Global Event Calendar and Registration

Standardizing Sterility Risk Assessments

Tue, 02 Feb 2010 08:28:06 GMT

N/A

ICH Quality Implementation Working Group (Q-IWG) Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10

Fri, 15 Jan 2010 15:06:53 GMT

Dates & Location: June 2, 2010 Tallinn, Estonia, October 5-8, 2010, Washington, DC USA

Cover Image

Mon, 01 Feb 2010 12:57:00 GMT

N/A

Registration Form

Mon, 01 Feb 2010 12:52:53 GMT

N/A

Risk-Based Inspections

Thu, 14 Jan 2010 15:06:38 GMT

N/A

2010 PDA/FDA Pharmaceutical Supply Chain Workshop

Mon, 04 Jan 2010 13:46:10 GMT

The 2010 PDA/FDA Pharmaceutical Supply Chain Workshop will focus on solutions to reduce the risk to Product Quality in Pharmaceutical Supply Chain. Recent experiences in the market have highlighted the need for effective regulations and controls. There is a surge in global cooperation and efforts toward harmonization of Good Manufacturing and Distribution Practices (GMPs and GDPs) and controls pertaining to the Supply Chain among members of industry and the regulatory agencies. Understanding and securing the entire ingredient manufacturing and distribution chain increases confidence in and helps ensure the quality and safety of medicines for our patients.

Agenda

Mon, 25 Jan 2010 08:58:26 GMT

N/A

Registration Fees

Tue, 12 Jan 2010 15:52:13 GMT

N/A

Registration Form

Tue, 12 Jan 2010 15:36:07 GMT

N/A

Exhibition and Sponsorships

Tue, 12 Jan 2010 15:21:25 GMT

N/A

Venue

Mon, 11 Jan 2010 12:03:42 GMT

N/A

Impurities in Drug Substance and Drug Product

Tue, 22 Dec 2009 09:44:25 GMT

Impurities in drug products frequently are the cause of side effects and must be controlled. This talk will define impurities and impurity profiles in both drug products and drug substances, discuss impurity limits then discuss the difference in older products of USP testing versus impurity profile testing. The ICH classification of impurities and analytical methods for impurity detection will be followed by discussion of the difficulty in detecting low levels of adventitious contamination as well as the deliberate contamination of products such as glycerine and heparin.

PDA's 5th Annual Global Conference on Pharmaceutical Microbiology

Tue, 15 Dec 2009 14:00:07 GMT

PDA's 5th Annual Global Conference on Pharmaceutical Microbiology will bring together all levels of industry professionals to network and benefit from a program that demystifies the underlying science of microbiology and seeks to solve the problems that our industry faces on a daily basis.

Venue

Fri, 05 Feb 2010 11:22:31 GMT

N/A

Microbiology PDA TRI Course Series

Wed, 03 Feb 2010 13:34:46 GMT

N/A

Call for Papers

Tue, 26 Jan 2010 11:21:53 GMT

N/A

Registration Fees

Fri, 18 Dec 2009 10:41:58 GMT

N/A

Registration Form

Fri, 18 Dec 2009 10:39:36 GMT

N/A

Exhibition and Sponsorships

Thu, 17 Dec 2009 08:20:21 GMT

N/A

2010 Pharmaceutical Freeze Drying Workshop

Tue, 15 Dec 2009 13:57:49 GMT

Freeze drying is a standard process in the pharmaceutical industry to stabilize drug products. An increasing number of molecules, particularly from biotech, are not stable in liquid water and the way to increase stability and shelf life is by means of freeze drying.

Registration Fees

Tue, 12 Jan 2010 15:54:03 GMT

N/A

Registration Form

Tue, 12 Jan 2010 15:44:33 GMT

N/A

Exhibition and Sponsorships

Thu, 17 Dec 2009 08:21:48 GMT

N/A

The Universe of Pre-Filled Syringes and Injection Devices

Tue, 15 Dec 2009 13:22:15 GMT

Pre-filled syringes and injection devices continue to be a growing market improving administration, compliance, safety, costs, and accuracy of drug delivery.

Call for Papers

Mon, 25 Jan 2010 09:51:34 GMT

N/A

Registration Form

Fri, 18 Dec 2009 11:05:42 GMT

N/A

Registration Fees

Fri, 18 Dec 2009 11:02:23 GMT

N/A

Exhibition and Sponsorships

Thu, 17 Dec 2009 08:22:44 GMT

N/A

Venue

Fri, 22 Jan 2010 10:21:00 GMT

N/A

2010 PDA Extractables/Leachables Workshop: Container Closure Systems, Impact to Drug Product Quality

Tue, 08 Dec 2009 15:35:40 GMT

N/A

Venue

Tue, 26 Jan 2010 10:57:57 GMT

N/A

2010 PDA/FDA Joint Regulatory Conference

Wed, 20 Jan 2010 08:57:50 GMT

N/A

Exhibition and Sponsorships

Wed, 09 Dec 2009 10:36:59 GMT

N/A

PDASE Executive Committee Meeting

Thu, 03 Dec 2009 09:20:57 GMT

PDASE Executive Committee Meeting Monthly Meeting For more details contact: Debora Steenson at pdase@bluestarservices.net

Sterile Process Technology New Facility Tour

Fri, 13 Nov 2009 11:30:45 GMT

Johnson & Johnson recently completed their state of the art Sterile Process Technology (SPT) center in Raritan, NJ. REGISTRATION IS LIMITED TO THE FIRST 75

Lean Manufacturing: What is the State of Lean/Six Sigma in Pharma and Biotech?

Fri, 06 Nov 2009 13:36:24 GMT

N/A

Agenda

Fri, 18 Dec 2009 17:16:55 GMT

N/A

2010 PDA Annual Meeting

Wed, 11 Nov 2009 11:36:57 GMT

N/A

Registration Form

Wed, 11 Nov 2009 11:29:21 GMT

N/A

Venue

Mon, 09 Nov 2009 13:51:48 GMT

N/A

2010 PDA Vaccine Conference

Thu, 05 Nov 2009 16:14:17 GMT

N/A

Agenda

Fri, 05 Feb 2010 10:27:13 GMT

N/A

Registration Form

Tue, 12 Jan 2010 15:49:18 GMT

N/A

Venue

Tue, 12 Jan 2010 11:15:39 GMT

N/A

Registration Fees

Thu, 07 Jan 2010 12:11:20 GMT

N/A

Exhibition and Sponsorships

Wed, 11 Nov 2009 14:54:35 GMT

N/A

PDA Southeast Chapter Laboratory Conference 2009

Tue, 27 Oct 2009 14:36:02 GMT

Laboratory Conference 2009 to be held on Thursday, November 12 at BTEC NCSU Centennial Campus, Raleigh, NC

2009 Dinner Meeting Series - A Revised Vision for Effective Enforcement and Benefits to the Public Health

Mon, 26 Oct 2009 15:40:32 GMT

N/A

Quality by Design Nov 9 SoCal PDA Irvine

Thu, 08 Oct 2009 13:21:43 GMT

N/A

NEPDA April 2010 Business Meeting

Thu, 08 Oct 2009 13:05:17 GMT

N/A

NEPDA February 2010 Business Meeting

Thu, 08 Oct 2009 12:53:00 GMT

N/A

NEPDA December 2009 Business Meeting

Thu, 08 Oct 2009 12:49:41 GMT

N/A

NEPDA October 2009 Business Meeting

Thu, 08 Oct 2009 11:36:55 GMT

N/A

New England Chapter May 2010 Dinner Meeting and Facility Tour

Thu, 08 Oct 2009 11:24:53 GMT

N/A

New England Chapter March 2010 Dinner Meeting and Facility Tour

Thu, 08 Oct 2009 11:19:32 GMT

N/A

Changes to USP Sterilization Chapters

Thu, 08 Oct 2009 09:04:09 GMT

N/A

Capital Area Chapter Meeting, USP: Quality Standards for Medicines

Mon, 28 Sep 2009 14:37:17 GMT

N/A

Midwest Chapter 1 Day Workshop on Sterilization and Quality Agreements

Thu, 24 Sep 2009 15:31:53 GMT

N/A

Implementation of Rapid Microbiological Methods

Thu, 10 Sep 2009 09:40:25 GMT

Presented by Michael J. Miller

An Insider Guide to Understanding ICH Q10: Pharmaceutical Quality Systems

Wed, 09 Sep 2009 16:24:23 GMT

Presented by Zena Kaufman of Abbott

PDA Southeast Chapter Winter Social

Wed, 09 Sep 2009 15:52:26 GMT

You are cordially invited to our Annual Winter Social to mingle with your colleagues and celebrate the accomplishments of our 2009 Student Scholarship Winners on Thursday, December 10, 2009 from 5:30 - 7:30pm. The event will be held at Bogart's Restaurant located at 510 Glenwood Avenue, Ste. 109, Raleigh. This year we are asking attendees to "pay it forward" by supporting the Helping Hand Mission by bringing an item(s) from their most needed list. Most Needed Items. Food, Clothing, Blankets, Toys, Hygiene Items (Toothpaste, Shaving Items, Soap, etc.) and Infant Products (Diapers, Wipes, Formula, Infant Cereal) We will arrange for all the items to reach the Mission the day after the event. Enjoy hor d'oeuvres and a complimentary beverage. Introduce your peers to the PDA Southeast Chapter by inviting them to this special event. DONATIONS NEEDED! Please consider donating warm clothing, or non perishable food items. Your donations will be greatly appreciated by a needy family this year! Register NOW! To register, please send an e-mail with your name and company name to pdase@bluestarservices.net by December 7th. Please include your member number and if you will be bringing a guest. Please provide your guest's name and their contact information.

Vendor Show followed by Ms. Diana Amador-Toro, FDA NJ District Director

Mon, 31 Aug 2009 09:35:52 GMT

"State of the Industry in the New Jersey District"

PDA Mountain States Chapter October 2009 Vendor Show and Speaker Dinner

Thu, 27 Aug 2009 16:14:05 GMT

N/A

Designing & Managing a World Class CAPA System

Thu, 20 Aug 2009 14:53:11 GMT

N/A

PDA & NIBRT: Animal Cell Culture: A Practicial Approach

Tue, 28 Jul 2009 09:33:45 GMT

N/A

Ireland at the Competitive Edge, Excellence in Quality, Operations and Innovation

Mon, 20 Jul 2009 11:35:19 GMT

PDA, ISPE and PharmaChemical Ireland present the second biannual Quality and Innovation Conference Ireland at the Competitive Edge: Excellence in Quality, Operations and Innovation Please find attached details of the event on the 3rd and 4th November at the Crowne Plaza Hotel, Santry, Dublin 9. For further information and bookings please contact Hazel Heggie at hazelheggie@eircom.net or Una Clarke at una.clarke@ibec.ie.

Assessing Risks of Changing Sterile Drug Manufacturing Sites Workshop

Mon, 06 Jul 2009 14:06:16 GMT

N/A

Venue

Thu, 09 Jul 2009 09:08:51 GMT

N/A

Registration Fees

Thu, 09 Jul 2009 08:07:07 GMT

N/A

Agenda

Wed, 08 Jul 2009 12:33:51 GMT

N/A

2009 PDA/FDA Joint Regulatory Conference Course Series

Mon, 06 Jul 2009 14:13:30 GMT

N/A

PDA Combination Products Workshop

Mon, 06 Jul 2009 14:12:33 GMT

N/A

2009 PDA/FDA Joint Regulatory Conference

Mon, 06 Jul 2009 14:11:27 GMT

N/A

Quebec City Fall Dinner Conference - Hotel Quebec

Mon, 15 Jun 2009 14:07:37 GMT

N/A

Montreal Fall Dinner Conference - Hilton Garden Hotel

Mon, 15 Jun 2009 13:33:29 GMT

N/A

Hot Topics in Visual Inspection

Thu, 11 Jun 2009 16:26:30 GMT

N/A

PDA UK Chapter Event at BioCity Nottingham, 10 September 2009

Thu, 11 Jun 2009 10:16:21 GMT

PDA UK Chapter Event

Southeast Chapter Executive Committee Meeting

Wed, 10 Jun 2009 08:55:56 GMT

N/A

PDA Southeast Chapter 2009 Annual Fall Conference

Fri, 05 Jun 2009 17:12:24 GMT

N/A

Ninth Annual PDA Southeast Chapter Golf Social

Fri, 05 Jun 2009 17:05:46 GMT

N/A

Breaking the Rapid Microbiological Method Financial Barrier

Fri, 05 Jun 2009 14:48:37 GMT

N/A

Toronto Dinner Meeting & Networking Boat Cruise

Fri, 05 Jun 2009 14:40:47 GMT

N/A

New England Chapter Dinner Meeting: TR45 - Depth Filtration

Tue, 02 Jun 2009 14:23:40 GMT

N/A

Half-Day Educational Conference on Data Integrity and Risk Management

Tue, 02 Jun 2009 13:51:50 GMT

N/A

2010 PDA/FDA Joint Regulatory Conference

Tue, 02 Jun 2009 10:28:04 GMT

The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues.

2010 PDA Extractables/Leachables Workshop: Container Closure Systems, Impact to Drug Product Quality

Wed, 20 Jan 2010 08:56:16 GMT

N/A

Speaker Manual

Wed, 14 Oct 2009 17:00:52 GMT

N/A

Venue

Fri, 05 Jun 2009 09:05:59 GMT

N/A

Exhibition and Sponsorships

Tue, 02 Jun 2009 10:39:50 GMT

N/A

Container Closure Integrity Dinner Meeting

Thu, 19 Feb 2009 16:16:12 GMT

PDA Technical Report 27: "Container-Closure Integrity" Speakers: Roger Asselta, Vice President of Technical Affairs, Genesis Packaging Technology Heinz Wolf, General Manager, Packaging Technologies and Inspection LLC

MSPDA Round Table

Fri, 08 May 2009 16:22:09 GMT

N/A

PDA New England Chapter Presents: PDA TR-15: Validation of Tangential Flow Filtration in Biopharmaceutical Applications

Fri, 08 May 2009 08:08:28 GMT

N/A

NEPDA Dinner Meeting - Hot Topics in Environmental Monitoring

Fri, 08 May 2009 08:59:05 GMT

N/A

2010 PDA Pharmaceutical Cold Chain Management Conference

Wed, 06 May 2009 09:25:17 GMT

April 12-15, 2010

Request a Brochure

Mon, 04 Jan 2010 14:14:51 GMT

N/A

Interactive Brochure

Wed, 25 Nov 2009 09:04:29 GMT

N/A

PDF Brochure

Wed, 25 Nov 2009 09:00:07 GMT

N/A

Continuing Education Credit

Thu, 05 Nov 2009 08:21:27 GMT

N/A

Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems

Mon, 02 Nov 2009 10:47:57 GMT

N/A

Program Agenda

Fri, 16 Oct 2009 11:44:53 GMT

N/A

Speaker Manual

Wed, 14 Oct 2009 16:58:58 GMT

N/A

Venue

Mon, 06 Jul 2009 11:25:14 GMT

N/A

Cold Chain 2010 Web Banner

Mon, 29 Jun 2009 09:41:30 GMT

N/A

Registration Fees

Tue, 16 Jun 2009 11:16:05 GMT

N/A

Registration Form

Tue, 16 Jun 2009 11:12:02 GMT

N/A

Call for Papers

Mon, 08 Jun 2009 08:45:39 GMT

N/A

Exhibition and Sponsorships

Fri, 08 May 2009 10:28:00 GMT

N/A

Australian Chapter Dinner Meeting - Biotech Validation

Tue, 07 Apr 2009 10:49:41 GMT

Dinner Meeting at Bruce County, Blackburn Road Blackburn

Australian Chapter Dinner Meeting - Lean Processes

Tue, 07 Apr 2009 10:45:09 GMT

Dinner Meeting at Metropole Hotel Conference Centre in Fitzroy

Risk Management

Tue, 07 Apr 2009 10:42:21 GMT

Dinner Meeting at Bruce County Motor Inn, Blackburn Road Blackburn.

Show All

Wed, 25 Mar 2009 14:14:53 GMT

N/A

2010 PDA Annual Meeting

Tue, 10 Mar 2009 13:54:04 GMT

Manufacturing Excellence March 15-19, 2010 | Orlando, Florida

Request a Brochure

Mon, 14 Dec 2009 17:02:15 GMT

N/A

Networking Events

Tue, 16 Jun 2009 10:37:34 GMT

Network at the 2010 PDA Annual Meeting.

Registration Form

Mon, 16 Mar 2009 13:57:32 GMT

N/A

Registration Fees

Mon, 16 Mar 2009 13:50:09 GMT

N/A

Venue

Fri, 13 Mar 2009 16:03:27 GMT

N/A

2010 PDA Annual Meeting Web Banner

Tue, 10 Mar 2009 14:15:45 GMT

N/A

Exhibition and Sponsorships

Tue, 10 Mar 2009 14:10:51 GMT

N/A

2010 PDA Biennial Training Conference

Wed, 07 Jan 2009 08:36:43 GMT

October 11-15, 2010 | Baltimore, Maryland
Join colleagues and connect with innovative leaders at the 2010 PDA Biennial Training Conference and take home the knowledge and skills you need to train your workforce.

Registration Form

Fri, 18 Dec 2009 10:58:11 GMT

N/A

Registration Fees

Fri, 18 Dec 2009 10:51:55 GMT

N/A

2010 PDA Biennial Training Conference Course Series

Thu, 03 Dec 2009 08:11:23 GMT

N/A

2010 Biennial Call for Papers

Thu, 22 Oct 2009 10:32:10 GMT

N/A

Venue

Thu, 09 Apr 2009 15:32:38 GMT

N/A

Exhibition and Sponsorships

Wed, 07 Jan 2009 09:34:34 GMT

N/A

Program Planning Committee

Wed, 07 Jan 2009 09:33:49 GMT

N/A

2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference

Tue, 25 Nov 2008 10:08:10 GMT

June 15-19, 2009 | Shanghai, China

Eric Berg

Fri, 15 May 2009 12:37:16 GMT

Director of Supplier Quality, Amgen, Inc.

Hung Chich Chang, PhD

Fri, 15 May 2009 12:34:40 GMT

Research Advisor, Product R&D, Eli Lilly and Company

Nevin Chang

Fri, 15 May 2009 12:32:14 GMT

Technical Manager, Colorcon China and Chair, IPEC China

Yi Chengdong, M.D., PhD

Fri, 15 May 2009 12:29:59 GMT

Deputy Director General of Shanghai, FDA

Rick Friedman

Fri, 15 May 2009 12:26:12 GMT

Director, Division of Manufacturing & Product Quality, CDER, FDA

Daniel Gold, Phd

Fri, 15 May 2009 12:11:40 GMT

President, D.H. Gold Associates, Inc.

Dittmar K. Nerger, PhD

Fri, 15 May 2009 12:08:24 GMT

Head of Strategic Sourcing Healthcare, Bayer Healthcare Ltd.

David R. Schoneker

Fri, 15 May 2009 12:06:08 GMT

Director of Global Regulatory Affairs, Colorcon

Janeen Skutnik

Fri, 15 May 2009 12:02:21 GMT

Chair-Elect, International Pharmaceutical Excipients Council (IPEC)

Anthony William Storey

Fri, 15 May 2009 11:59:22 GMT

Contract Operations Quality Assurance Manager, Pfizer

Brenda Uratani, PhD

Fri, 15 May 2009 11:56:08 GMT

Senior Compliance Officer, Center for Drug Evaluation and Research, FDA

Martin VanTrieste

Fri, 15 May 2009 11:29:05 GMT

Vice President Quality, Commercial Operations Amgen, Inc.

Weibing Wang

Fri, 15 May 2009 11:23:29 GMT

Vice President of Quality, Zhejiang Hisun Pharmaceutical Co. Ltd.

Neil Wilkinson

Fri, 15 May 2009 11:15:49 GMT

Partner, David Begg Associates

Season Xu

Fri, 15 May 2009 11:10:32 GMT

Director of Manufacturing, Sigma-Aldrich (WuXi) Life Science Technology Co. Ltd.

Keynote Presenters-Yi Chengdong and Rick Friedman

Thu, 16 Apr 2009 11:03:28 GMT

Yi Chengdong, Deputy Director General of Shanghai FDA and Rick Friedman, Director of the Division of Manufacturing & Product Quality in the Center for Drug Evaluation and Research (CDER), Office of Compliance, US FDA will be the Keynote Presenters.

PDA Membership Benefits-Chinese

Wed, 15 Apr 2009 14:16:48 GMT

N/A

PDA Membership Benefits-English

Wed, 15 Apr 2009 15:30:39 GMT

N/A

SIFDS-PDA Shanghai Joint Development Center-SHJDC

Wed, 01 Apr 2009 08:04:22 GMT

In order to enhance quality in China's pharmaceutical manufacturing, to improve pharmaceutical technology and quality control,to achieve international standards in pharmaceutical manufacturing and to boost the expertise of supervision in China.

Program Planning Committee

Fri, 13 Mar 2009 14:12:29 GMT

N/A

Agenda - Chinese

Thu, 12 Mar 2009 15:47:04 GMT

N/A

Agenda - English

Wed, 04 Mar 2009 10:25:00 GMT

N/A

Brochure - English

Tue, 24 Mar 2009 10:04:35 GMT

N/A

Brochure - Chinese

Tue, 14 Apr 2009 11:56:46 GMT

N/A

2009 PDA/FDA Asia Pacific Pharmaceutical Ingredient Supply Chain Conference Training Courses

Tue, 24 Feb 2009 10:21:08 GMT

N/A

Mayfair Penta Room Reservation Form

Thu, 19 Feb 2009 15:43:36 GMT

N/A

Mayfair Deluxe Room Reservation Form

Thu, 19 Feb 2009 15:40:40 GMT

N/A

CIBT-Visas and Passports

Fri, 13 Feb 2009 10:29:33 GMT

N/A

Visa Information-Chinese Embassy

Fri, 13 Feb 2009 10:27:13 GMT

N/A

Message from the Committee Co-Chairs

Thu, 05 Feb 2009 10:39:48 GMT

N/A

Banner

Thu, 29 Jan 2009 10:42:56 GMT

N/A

China PDA Chapter

Fri, 15 May 2009 10:51:10 GMT

N/A

PDA FDA SHFDA logo

Thu, 15 Jan 2009 08:50:32 GMT

N/A

Venue

Tue, 13 Jan 2009 14:55:50 GMT

Venue for 2009 PDA-FDA Asia Pacific Ingredient Supply Chain Conference

Registration Form

Tue, 09 Dec 2008 10:47:07 GMT

N/A

Registration Fees

Tue, 25 Nov 2008 10:37:15 GMT

N/A

Exhibition and Sponsorships

Tue, 25 Nov 2008 10:33:29 GMT

N/A

PDA Workshop: Cleanroom Technology and Contamination Control

Sat, 08 Nov 2008 11:06:35 GMT

April 19, 2009 | Las Vegas, Nevada

Program Committee

Thu, 15 Jan 2009 11:22:50 GMT

N/A

Venue

Wed, 31 Dec 2008 10:08:04 GMT

N/A

Exhibition and Sponsorships

Fri, 12 Dec 2008 10:11:10 GMT

N/A

Agenda

Tue, 09 Dec 2008 09:45:42 GMT

N/A

Registration Fees

Wed, 19 Nov 2008 12:04:23 GMT

N/A

2009 PDA Annual Meeting

Sat, 08 Nov 2008 11:36:16 GMT

N/A

About PDA Conferences

Fri, 07 Nov 2008 04:55:27 GMT

N/A

Obtaining a U.S. Visa

Fri, 07 Nov 2008 04:53:42 GMT

N/A

European Events

Thu, 06 Nov 2008 04:11:57 GMT

N/A

2010 PDA Europe Conference: Innovative Aseptic Technologies

Fri, 05 Feb 2010 09:53:29 GMT

10-11 June, 2010 | Basel, Switzerland Aseptically manufactured products are susceptible to contamination from many sources. Usually the most critical ones are microbial contaminants. Safety of these products is of...

2010 PDA Europe Conference on Endotoxin

Fri, 05 Feb 2010 05:51:48 GMT

April 13-14, 2010 | Barcelona, Spain This edition focuses on the results achieved by the PDA and SFSTP experts working on a document that will give an overview on...

ICH Quality Implementation Working Group (Q-IWG) Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10

Thu, 04 Feb 2010 10:43:40 GMT

Dates & Location: June 2, 2010 Tallinn, Estonia, October 5-8, 2010, Washington, DC USA

Interest Group Meeting: Technology Transfer

Thu, 28 Jan 2010 08:46:38 GMT

March 25, 2010 | Frankfurt, Germany

Interest Group Meeting: Visual Inspection

Thu, 28 Jan 2010 08:24:56 GMT
April 22, 2010 | Frankfurt, Germany

Interest Group Meeting: Pre-filled Syringes

Tue, 26 Jan 2010 11:22:37 GMT
April 15, 2010 | Berlin, Germany

PDA Vaccines Workshop: New Technologies for the 21st Century

Mon, 25 Jan 2010 04:26:45 GMT
June 16, 2010 | Berlin, Germany Advances in research are leading to development of new vaccines to be used for new diseases. Recent events such as the H1N1 Influenza Pandemic, the threat of...

Interest Group Meeting: Freeze Drying

Fri, 15 Jan 2010 11:43:10 GMT
N/A

PDA Workshop on Advanced Therapy Medicinal Products: ATMPs - 21st Century Pharmaceuticals, a New Paradigm

Wed, 13 Jan 2010 11:29:05 GMT
June 15, 2010 | Berlin, Germany The emergence of gene therapy, cell therapy and tissue engineering reflect biomedical advancements which offer great...

2010 PDA Europe Visual Inspection Forum

Thu, 17 Dec 2009 06:10:34 GMT
N/A

Interest Group Meeting Filtration

Wed, 16 Dec 2009 08:35:05 GMT
09 February, 2010 | Brussels, Belgium

2010 PDA Europe Workshop on Filtration

Fri, 11 Dec 2009 09:30:43 GMT
13-14 April, 2010 | Berlin, Germany

2010 PDA Europe Conference on Pharmaceutical Cold Chain Management: Temperature Controlled Pharmaceutical Supply Chain - From Manufacturing to the End-User

Fri, 11 Dec 2009 08:51:10 GMT
7-8 October, 2010 | Berlin, Germany

Workshop on Biofilms: The Impact of Biofilms on Pharmaceutical and Biopharmaceutical Manufacturing

Fri, 11 Dec 2009 08:21:18 GMT
20-21 April, 2010 | Frankfurt, Germany
Biological contamination of water systems continues to present significant challenges to the pharmaceutical, biotechnology, and medical device industries. Bacteria, in particular, are well...

PDA 3rd Monoclonal Antibodies Workshop: Managing the Challenges of Comparability: Scientific and Regulatory Considerations for Monoclonal Antibodies

Fri, 11 Dec 2009 05:38:11 GMT
June, 17-18 2010 | Berlin, Germany

2010 PDA Europe Workshop on Stoppers & Elastomers

Fri, 11 Dec 2009 04:58:34 GMT
March 24-25, 2010 | Cologne, Germany
The workshop gives a comprehensive overview of elastomeric components relevant for...

PDA Europe 2010 Training Course: Rapid Microbiology Methods

Thu, 10 Dec 2009 11:56:21 GMT
March 9-11, 2010 | Berlin, Germany

PDA Europe 2010 Training Course: Disposables/Single Use Systems

Thu, 10 Dec 2009 10:36:42 GMT
March 2-4, 2010 | Berlin, Germany

PDA Europe Workshop: Silicon oil and its Applications for Parenteral Products

Wed, 09 Dec 2009 12:40:10 GMT
March 23, 2010 | Cologne, Germany
Silicon oil is an important processing aid in the pharmaceutical and biopharmaceutical industry. It is used for...

2010 PDA Europe Workshop on Small Batch Production

Tue, 08 Dec 2009 05:37:04 GMT
February 23-24, 2010 | Berlin, Germany
The goal of the workshop is to give an update on the status of small batch production which includes...

Courses following PDA's Investigational Medicinal Products Conference

Tue, 01 Dec 2009 09:35:53 GMT
Courses following PDA's Investigational Medicinal Products Conference

Clinical Trial Formulation Development

Wed, 25 Nov 2009 09:15:58 GMT
N/A

2010 PDA Europe: Parenterals Conference

Tue, 13 Oct 2009 11:57:41 GMT
N/A

PDA Workshop on Technical Report 22: Process Simulation Testing for Aseptically Filled Products

Tue, 13 Oct 2009 10:44:50 GMT
February 25, 2010 | Berlin, Germany PDA's original TR-22, published in 1996, described the considerations and planning of a Aseptic Process Simulation Testing to an entire generation of pharmaceutical scientists and engineers. This revision will maintain clarity of prior version, reinforce scientific elements...

PDA Europe Conference on Pharmaceutical Microbiology

Wed, 30 Sep 2009 09:59:20 GMT
February 23-24, 2010 | Berlin, Germany PDA's Conference on Pharmaceutical Microbiology will bring together all levels of industry professionals to network and benefit from a program that....

PDA/EMEA Training Courses

Thu, 16 Jul 2009 03:21:00 GMT
There will be various post-conference training courses related to the conference topics...

PDA Workshop: Quality by Design - Putting Principles into Practice

Thu, 14 May 2009 10:49:14 GMT
September 22-23, 2009 | Frankfurt, Germany Quality by Design? What is really meant by this? What is different from how development and manufacturing as well as documentation has been conducted in the past? What do regulatory bodies understand by this? Do their expectations change with respect to dossier contents and during inspections? ...

Interest Group Meeting: Pre-filled Syringes

Tue, 03 Mar 2009 11:27:10 GMT
May 27, 2009 | Berlin, Germany The focus topic will be on Polymer Syringes and Advantages compared to Glass Syringes . Product related . Process related . User Perspective and more...

PDA Hands-on Workshop on Disposables/Single-Use-Technology

Wed, 28 Jan 2009 12:21:28 GMT
3-4 March 2009 | Munich, Germany Disposables, or single-use -technology/ systems, are still in an early stage concerning the industrial use. Indeed, we have a lot of experience with the traditional way of running processes using e.g. steel vessels, containers, separation systems and filling lines connected by steel tubing.

PDA/EMEA Joint Conference

Sat, 17 Jan 2009 16:20:52 GMT
13-14 October 2009 | Berlin, Germany

The 3rd PDA-EMEA Conference covers legislation, guidance and initiatives from the European Commission and EMEA. Three parallel tracks will address: (1) Supply chain quality, (2) Implementation of ICH Q8-9-10, and (3) Manufacturing and GMP.

2009 PDA Europe Conference on Endotoxins

Tue, 28 Oct 2008 08:18:24 GMT
17-18 March | Paris, France
This important event focuses on basic aspects of Endotoxins and Bacterial Endotoxin Testing (BET) as well as GMP issues.

PDA Workshop on Annex 1 EU GMP Guide and Its Impact on Media Fill Practices

Mon, 15 Sep 2008 12:44:55 GMT
N/A

Global Challenges for Investigational Medicinal Products

Mon, 15 Sep 2008 12:11:37 GMT
N/A

PDA Discussion Forum on Revision of Annex 1 to the EU GMP Guide: Issues and Challenges

Mon, 15 Sep 2008 10:52:15 GMT
N/A

Monoclonal Antibodies: Trends in Science, Technology and European Regulatory Considerations

Sun, 21 Sep 2008 16:09:38 GMT
N/A

Sterilisation Technologies in Development and Manufacturing of Parenterals

Mon, 15 Sep 2008 15:01:35 GMT
N/A

Accreditation

Mon, 11 Aug 2008 15:54:46 GMT
N/A

Speaker Opportunities

Mon, 11 Aug 2008 15:54:41 GMT
N/A

2009 PDA Visual Inspection Forum

Fri, 31 Oct 2008 12:29:55 GMT
October 19-22, 2009 | Bethesda, Maryland

Brochure

Mon, 06 Jul 2009 09:32:11 GMT
N/A

Agenda

Wed, 27 May 2009 10:06:08 GMT
N/A

Continuing Education Units

Fri, 22 May 2009 13:59:03 GMT
N/A

Program Planning Committee

Tue, 19 May 2009 13:20:02 GMT
N/A

An Introduction to Visual Inspection

Wed, 25 Feb 2009 11:17:52 GMT
N/A

PDA 2009 Visual Inspection Forum Banner

Tue, 24 Feb 2009 14:13:54 GMT
N/A

Exhibition and Sponsorships

Fri, 16 Jan 2009 15:15:03 GMT
N/A

Registration Form

Thu, 20 Nov 2008 11:43:00 GMT
N/A

Registration Fees

Wed, 19 Nov 2008 09:09:06 GMT
N/A

Venue

Tue, 11 Nov 2008 14:45:23 GMT
N/A

PDA's 4th Annual Global Conference on Pharmaceutical Microbiology

Fri, 31 Oct 2008 12:02:04 GMT
October 5-8, 2009 | Bethesda, Maryland

Venue

Mon, 11 Jan 2010 11:50:33 GMT
N/A

2010 Cold Chain Exhibitor Contract

Mon, 12 Oct 2009 09:53:56 GMT
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Presenter Bio's

Wed, 16 Sep 2009 14:36:27 GMT
N/A

Recommended Reading

Mon, 10 Aug 2009 13:13:19 GMT
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Brochure

Mon, 06 Jul 2009 09:31:05 GMT
N/A

Agenda

Mon, 18 May 2009 15:53:34 GMT
N/A

Continuing Education Units

Mon, 11 May 2009 10:04:18 GMT
N/A

Microbiology 2009 Web Banner

Thu, 26 Feb 2009 13:19:53 GMT
N/A

Microbiological Issues in Non-Sterile Manufacturing

Wed, 25 Feb 2009 11:23:20 GMT
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Microbiology of Water in a cGMP Environment

Wed, 25 Feb 2009 11:22:10 GMT
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Environmental Monitoring

Wed, 25 Feb 2009 11:20:09 GMT
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Program Committee

Thu, 15 Jan 2009 13:10:58 GMT
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Registration Form

Wed, 19 Nov 2008 11:41:48 GMT
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Registration Fees

Wed, 19 Nov 2008 08:54:12 GMT
N/A

Venue

Mon, 10 Nov 2008 17:57:05 GMT
N/A

Exhibition and Sponsorships

Fri, 31 Oct 2008 12:08:20 GMT
N/A

PDA's 4th Annual Global Conference on Pharmaceutical Microbiology Course Series

Tue, 24 Feb 2009 10:45:21 GMT
October 8, 2009

Conference Program Planning Committees

Mon, 11 Aug 2008 15:54:34 GMT
N/A

Program Advisory Board

Mon, 08 Sep 2008 16:10:58 GMT
N/A

PDA Combination Products Workshop

Thu, 30 Oct 2008 13:10:08 GMT
Solving Problems in an Evolving Regulatory Environment
September 16-17, 2009 | Washington, D.C.

Assessing Risks of Changing Sterile Drug Manufacturing Sites

Mon, 06 Jul 2009 14:16:12 GMT
N/A

Agenda

Mon, 06 Apr 2009 13:13:47 GMT
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Program Planning Committee

Wed, 21 Jan 2009 16:23:50 GMT
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Venue

Mon, 10 Nov 2008 17:18:41 GMT
N/A

Registration Fees

Fri, 31 Oct 2008 09:32:46 GMT
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Contamination Control Registration Form

Fri, 31 Oct 2008 08:31:37 GMT
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2009 PDA/FDA Joint Regulatory Conference

Thu, 30 Oct 2008 13:56:14 GMT
N/A

2009 PDA/FDA Joint Regulatory Conference

Thu, 30 Oct 2008 11:56:07 GMT
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Rabia Ballica, PhD

Tue, 01 Sep 2009 16:17:43 GMT
Rabia Ballica, PhD, CMC/Product Reviewer, CBER, FDA

Dennis M. Bensley, Jr., PhD

Tue, 01 Sep 2009 16:22:37 GMT
Dennis M. Bensley, Jr., PhD, Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM, FDA

Eric Berg

Tue, 01 Sep 2009 16:27:54 GMT
Eric Berg, Director of Supplier Quality, Amgen, Inc.

Michael W. Bonney

Fri, 22 May 2009 10:13:30 GMT
Michael W. Bonney, President and CEO, Cubist Pharmaceuticals, Inc.

Jon Clark

Tue, 01 Sep 2009 16:20:39 GMT
Jon Clark, Associate Director For Policy, CDER, FDA

Howard Drake

Tue, 01 Sep 2009 16:00:04 GMT
Howard Drake, Vice President, Ompi of America

Katherine Eban

Fri, 10 Jul 2009 10:04:41 GMT
Katherine Eban Investigative Journalist and Author

John Eltermann

Tue, 01 Sep 2009 16:19:10 GMT
John Eltermann, Director, Division of manufacturing and Product Quality, CBER, FDA

Joseph C. Famulare

Fri, 22 May 2009 13:11:53 GMT
Joseph C. Famulare, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, FDA

Thomas Friedli, PhD

Fri, 22 May 2009 13:06:33 GMT
Thomas Friedli, Managing Director Tectem, University of St. Gallen, Switzerland

Rick Friedman

Fri, 22 May 2009 13:00:32 GMT
Rick Friedman, Director, Division of Manufacturing and Product Quality, CDER, FDA

Betsy Fritschel

Tue, 01 Sep 2009 16:15:51 GMT
Betsy Fritschel, Director, Corporate Quality and Compliance Worldwide, Johnson & Johnson

Nigel Hamilton

Wed, 27 May 2009 10:00:45 GMT
Nigel Hamilton, Quality Director, Sanofi Aventis

Lothar Hartmann, PhD

Fri, 10 Jul 2009 10:07:02 GMT
Lothar Hartmann, PhD Head of External Relations - Global Quality, Hoffmann-La Roche

Brian Hasselbalch

Fri, 22 May 2009 12:52:17 GMT
Brian Hasselbalch,Team Leader, Guidance and Policy Team, FDA/CDER/Office of Compliance

Christian Helbig

Tue, 01 Sep 2009 16:14:08 GMT
Christian Helbig, Manager Business Development, SCHOTT North America Inc.

Malcolm Holmes

Fri, 10 Jul 2009 10:09:10 GMT
Malcolm Holmes Retired [previously director Quality Assurance GSK (Glaxosmithkline)]

Kirk Huber

Fri, 10 Jul 2009 10:11:11 GMT
Kirk Huber Executive Director and Global Head of Laboratory and Preclinical Quality Assurance, Novartis Pharmaceutical Corporation

Brian Johnson

Fri, 10 Jul 2009 10:19:15 GMT
Brian Johnson, Director/Team Leader of Contract Operations Quality Assurance, Pfizer Global Manufacturing

Christopher Joneckis, PhD

Tue, 01 Sep 2009 16:12:31 GMT
Christopher Joneckis, PhD, Senior Advisor for CMC Issues, Office of the Center Director CBER, FDA

Shane D. Killian, M.S.

Tue, 01 Sep 2009 16:10:54 GMT
Shane D. Killian, M.S., Manager, Johnson & Johnson Pharmaceutical Supply

Duncan Low, PhD

Tue, 01 Sep 2009 16:09:04 GMT
Duncan Low, PhD, Scientific Executive Director, Amgen, Inc.

Anthony Luttrell

Tue, 01 Sep 2009 16:06:12 GMT
Anthony Luttrell, President, Raland Technologies, LLC

Mary Anne Malarkey

Tue, 01 Sep 2009 16:04:47 GMT
Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA

Sei-ichi Manabe

Fri, 10 Jul 2009 10:22:34 GMT
Sei-ichi Manabe President, Sepa-Sigma, Inc.

Daniel G. McChesney, M.S., PhD

Wed, 03 Jun 2009 16:54:58 GMT
Daniel G. McChesney, M.S., PhD Director, Office of Surveillance & Compliance Center for Veterinary Medicine, FDA

Edwin Melendez

Tue, 01 Sep 2009 16:03:40 GMT
Edwin Melendez, Consumer Safety Officer, CDER, FDA

Karen Migliaccio

Tue, 01 Sep 2009 16:01:11 GMT
Karen Migliaccio, President, migliaccio Consulting, LLC

Charles Mignosa

Wed, 02 Sep 2009 15:10:28 GMT
Charles Mignosa, President, Business systems Architects, LLC

Paolomi Mukherji

Thu, 13 Aug 2009 17:00:50 GMT
Paolomi Mukherji, Manager, Clarkston Consulting

Richard Norgard

Fri, 10 Jul 2009 10:24:21 GMT
Richard Norgard Executive Director, Global Manufacturing Compliance, Pfizer

Stephen Notarnicola, PhD

Tue, 01 Sep 2009 15:57:48 GMT
Stephen Notarnicola, PhD, Principal Investigator,Biogen Idec

Ulku Oktem, PhD

Fri, 22 May 2009 12:38:49 GMT
Ulku Oktem, PhD, Adjunct Professor, Operations and Information Management Department, Wharton School of the University of Pennsylvania

Gerard Pearce

Fri, 10 Jul 2009 10:26:45 GMT
Gerard Pearce, Executive Vice President, SQA Services Inc.

Michael J. Popek, M.S.

Tue, 01 Sep 2009 15:56:24 GMT
Michael J. Popek, M.S., Supervisory Microbiologist, Center for Veterinary Medicine, FDA

Anurag S. Rathore, PhD

Fri, 22 May 2009 12:34:00 GMT
Anurag S. Rathore, PhD, Process Development, Amgen, Inc.

Edwin Rivera-Martinez

Tue, 01 Sep 2009 15:54:33 GMT
Edwin Rivera-Martinez, Chief, Manufacturing Assessment and Preapproval Complaince Branch Division of Manufacturing and Product Quality, Office of Compliance,CDER, FDA

Stephan Roenninger, PhD

Fri, 22 May 2009 13:48:41 GMT
Stephan Roenninger, PhD Global Quality Manager, F. Hoffmann-La Roche, Ltd.

Barbara A. Ryan

Fri, 22 May 2009 12:05:41 GMT
Barbara A. Ryan, Analyst, Deutsche Bank

Swroop Sahota, PhD

Tue, 26 May 2009 12:34:42 GMT
Swroop Sahota, PhD Vice-president of Global Quality Services, Schering-Plough

Robert Sausville

Tue, 01 Sep 2009 15:53:27 GMT
Robert Sausville, Supervisor, Consumer Safety,CBER, FDA

David R. Schoneker

Tue, 01 Sep 2009 15:50:18 GMT
David R. Schoneker, Director of Global Regulatory Affairs, Colorcon

Jacqueline Scott, J.D., M.L.

Fri, 22 May 2009 12:03:06 GMT
Jacqueline Scott, J.D., M.L., Professor, Harrison Institute for Public Law, Georgetown University

Joshua M. Sharfstein, MD

Wed, 27 May 2009 13:24:01 GMT
Joshua M. Sharfstein, MD, Principal Deputy Commissioner, FDA

James Shirey

Tue, 01 Sep 2009 15:49:13 GMT
James Shirey, Director/Team Leader, Pfizer, Inc.

Jeffrey Shuren, MD, J.D.

Fri, 10 Jul 2009 10:29:48 GMT
Jeffrey Shuren, MD, J.D. ,Associate Commissioner for Policy and Planning, FDA

Steven Silverman

Fri, 10 Jul 2009 10:33:38 GMT
Steven SilvermanAssistant Director, Office of Compliance, FDA

James Skrine

Fri, 22 May 2009 13:52:30 GMT
James Skrine, Executive Director / Site Head, Quality, Amgen, Inc.

Janeen Skutnik

Fri, 10 Jul 2009 10:35:48 GMT
Janeen Skutnik, Director/Team Leader of Quality & Regulatory Policy, Pfizer

Douglas Stearn

Tue, 01 Sep 2009 15:47:56 GMT
Douglas Stearn, Director, Division of Compliance Policy, Office of Regulatory Affairs, FDA

Wayne Taylor, PhD

Fri, 22 May 2009 13:59:01 GMT
Wayne Taylor, PhD, Chairman, Taylor Enterprises

Lynn Torbeck

Tue, 01 Sep 2009 15:46:27 GMT
Lynn Torbeck, Principal Statistician, Torbeck and Assoc., Inc.

Wallace Torres

Fri, 22 May 2009 14:02:42 GMT
Wallace Torres, QuaSaR Program Leader, Hoffman-La Roche Inc.

Kimberly Trautman

Fri, 10 Jul 2009 10:43:39 GMT
Kimberly Trautman Medical Device GMP/Quality Systems Expert, FDA

Timothy Ulatowski

Fri, 10 Jul 2009 10:50:56 GMT
Timothy Ulatowski, Director, Office of Compliance, CDRH, FDA

David Ulrich

Tue, 01 Sep 2009 15:45:00 GMT
David Ulrich, Distribution and Logistics QA Manager, Abbott Laboratories

Martin VanTrieste

Fri, 10 Jul 2009 10:53:14 GMT
Martin VanTrieste Vice President Commercial Quality, Amgen, Inc.

Greg Walker

Tue, 01 Sep 2009 15:43:37 GMT
Greg Walker, Director, Wyeth Pharmaceuticals

Steven Wolfgang, PhD

Fri, 10 Jul 2009 10:55:36 GMT
Steven Wolfgang, PhD, Consumer Safety Officer, CDER, FDA

Janet Woodcock, M.D.

Tue, 01 Sep 2009 16:54:25 GMT
Janet Woodcock, M.D., Director, CDER, FDA

Klaus Wuttke

Tue, 01 Sep 2009 15:36:25 GMT
Klaus Wuttke, DirectorGerresheimer Bunde GmbH

Victor Yamauchi

Tue, 01 Sep 2009 15:33:02 GMT
Victor Yamauchi, Director of Supplier Quality, Amgen, Inc.

Barbara Zinck

Fri, 10 Jul 2009 10:59:14 GMT
Barbara Zinck Senior Director, Corporate Compliance, Cambrex Corporation

Recommended Reading

Thu, 23 Jul 2009 07:50:56 GMT
N/A

Assessing Risks of Changing Sterile Drug Manufacturing Sites

Mon, 06 Jul 2009 14:17:37 GMT
N/A

Brochure

Wed, 06 May 2009 14:33:07 GMT
N/A

Agenda

Thu, 02 Apr 2009 15:50:13 GMT
N/A

Registration Fees

Fri, 31 Oct 2008 08:58:23 GMT
N/A

Exhibition and Sponsorships

Thu, 30 Oct 2008 12:37:57 GMT
N/A

Continuing Education Units

Wed, 15 Apr 2009 16:07:18 GMT
N/A

Program Planning Committee

Wed, 19 Nov 2008 11:44:07 GMT
N/A

PDA Combination Products Workshop

Thu, 30 Oct 2008 13:17:30 GMT
N/A

Registration Form

Thu, 30 Oct 2008 12:54:57 GMT
N/A

2009 PDA Regulatory Conference Courses

Thu, 30 Oct 2008 12:49:53 GMT
N/A

Web banner

Thu, 30 Oct 2008 12:41:35 GMT
N/A

Venue

Wed, 08 Apr 2009 15:06:29 GMT
N/A

Chapter Events

Tue, 28 Oct 2008 10:49:08 GMT
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The Importance of rapid Methods Technology in the Pharma Industry" and "Recombinant Factor C Procedure for the Detection of Gram Negative Bacterial Endotoxin

Wed, 11 Mar 2009 14:22:39 GMT
N/A

PDA Technical Report 27: "Container-Closure Integrity"

Wed, 11 Mar 2009 14:12:49 GMT
N/A

CRITICAL UTILITY CASE STUDY: L'OREAL WATER SYSTEM

Thu, 20 Nov 2008 11:40:10 GMT
N/A

Training Courses

Fri, 10 Oct 2008 14:09:22 GMT
N/A

Bioassay Development and Validation

Mon, 25 Jan 2010 18:45:10 GMT
November 3 - 4, 2010 This two-day course covers the fundamental concepts behind the statistical methods that inform development, analysis, validation, and monitoring of biological assays.

Achieving cGMP Compliance During Development of a Biotechnology Product

Mon, 25 Jan 2010 18:38:37 GMT
May 7, 2010 This participant-interactive lecture is designed to provide attendees guidance on how cGMP regulations and guidance's should be interpreted and applied across the product lifecycle from product development through the final stages of biotechnology drug manufacture and approval (i.e. preclinical through phase III).

Integration of Risk Management into Quality Systems - Extended

Mon, 25 Jan 2010 18:30:28 GMT
May 5 - 6, 2010 This workshop will focus on methods to imbed risk management concepts into elements of the quality systems and utilize current quality data to develop a closed-loop and "living" risk management program.

PDA's 5th Annual Global Conference on Pharmaceutical Microbiology Course Series

Mon, 25 Jan 2010 16:56:04 GMT
In conjunction with PDA's 5th Annual Global Conference on Pharmaceutical Microbiology, the PDA Training and Research Institute (PDA TRI) is offering four courses related to the latest technologies, newly-enacted regulations and updated proceses in the pharmaceutical and biopharmaceutical industries.

Choosing the "Right" Microbial Identification Program for Your Biopharmaceutical/Pharmaceutical Quality Control Laboratory

Wed, 02 Dec 2009 09:33:49 GMT
This two day lecture, including case studies on the second day, will give you the knowledge needed to develop a robust microbial identification program for your site.

2010 Saint Louis Course Series

Mon, 23 Nov 2009 10:06:07 GMT
April 8 - 8, 2010 Five Pharmaceutical and biopharmaceutical courses straight from the experts.

2010 San Diego Course Series

Tue, 10 Nov 2009 15:22:24 GMT
February 22 - 24, 2010 5 Pharmaceutical and Biopharmaceutical courses straight from the experts.

Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems

Thu, 05 Nov 2009 16:41:03 GMT
N/A

2010 PDA Annual Meeting Course Series

Mon, 26 Oct 2009 14:20:46 GMT
In conjunction with the 2010 PDA Annual Meeting, the PDA Training and Research Institute (PDA TRI) is offering courses related to the latest technologies, newly-enacted regulations and updated processes in the pharmaceutical and biopharmaceutical industries. All courses will be held on March 18-19, at the Gaylord Palms Resort and Convention Center.

2010 Aseptic Processing Training Program

Wed, 24 Sep 2008 08:24:22 GMT
Training and information needed to properly evaluate and improve your aseptic processes to ensure sterile product.

2009 PDA/FDA Joint Regulatory Conference Course Series

Fri, 17 Oct 2008 16:19:59 GMT
Septmber 17-18, 2009
Ten courses covering topics focused on or related to regulatory issues in the pharmaceutical and biopharmaceutical industry.

Downstream Processing: Separations, Purifications and Virus Removal

Tue, 04 Nov 2008 13:39:03 GMT
July 20-23, 2010

Development of Pre-filled Syringes

Tue, 03 Feb 2009 14:40:23 GMT
April 28-30, 2010
Bethesda, Maryland
This course will provide an overview of the relevant practical aspects of developing and processing pre-filled syringes focusing on process steps such as siliconisation, filling, stoppering and visual inspection. The participant will also learn about the relevant methods for in-process controls and functionality testing of syringes: silicon oil determination and distribution in the syringe, friction force measurements and particulates determination.

Fermentation/Cell Culture Technologies Training Workshop

Thu, 09 Oct 2008 10:59:47 GMT
June 23-25, 2010
This workshop will provide an insight and overview into the fundamentals of Bioreactors and Fermentation Technology for both experienced individuals and those who have a rudimentary understanding of the processes.

Autoclave Operations

Wed, 08 Oct 2008 09:24:31 GMT
September 2 - 4, 2009
Using the Fedagari Autoclave, this course will focus on principles and processes related to sterilization science.

Safety Ventilation in Biotech and Pharmaceutical Cleanrooms; Risk Assessment of Airborne Contamination

Thu, 09 Oct 2008 09:27:39 GMT
September 9 -11, 2009
This three-day course covers the fundamentals of airborne contamination and their application in pharmaceutical and biotech cleanrooms.

Fundamentals of D, F, and z Value Analysis

Mon, 29 Sep 2008 16:58:56 GMT
October 6 - 7, 2009
Bethesda, Maryland
Acquire the necessary knowledge to determine D, F, and z values, which you can use immediately when you return to your job.

Validating a Steam Sterilizer

Mon, 29 Sep 2008 17:19:50 GMT
October 8 - 9, 2009
Bethesda, Maryland
Experience hands-on training with a fully functional steam autoclave and thermal validation equipment.

2009 New Brunswick Course Series

Fri, 19 Dec 2008 15:08:06 GMT
OCTOBER 19-21, 2009
This PDA TRI course series features seven pharmaceutical and biopharmaceutical courses led by industry experts.

San Francisco Course Series

Mon, 06 Apr 2009 15:47:37 GMT
November 2-4, 2009
9 Pharmaceutical and Biopharmaceutical courses straight from the experts.

Pharmaceutical Water System Microbiology

Wed, 15 Oct 2008 15:09:18 GMT
March 3-5, 2010
This course will consist of lecture and lab components focused on microbiological issue with biopharmaceutical Purified Water and WFI systems.

An Introduction to Visual Inspection

Tue, 24 Feb 2009 12:55:18 GMT
May 11-12, 2010
This course covers the fundamentals of visual inspection and their application to injectable products.

Advanced Environmental Mycology Identification Workshop

Fri, 20 Feb 2009 12:52:44 GMT
October 28 - 30, 2009
Over the course of three days, this hands-on laboratory course will build upon what participants learned in the PDA Environmental Mycology Identification Workshop.

Sterile Filtration in the Biopharmaceutical Industry, Course II

Fri, 30 Jan 2009 16:28:08 GMT
October 27 - 29, 2009

Contamination Control

Fri, 20 Feb 2009 12:38:58 GMT
November 2 - 5, 2009
This course is intended to give you a complete understanding of what is involved in developing a complete contamination control program.

Effective Application of a Quality Systems Approach to Pharmaceutical cGMPs in Compliance with the FDA Guidance

Mon, 22 Dec 2008 13:43:39 GMT
June 1-2, 2009
Effective Application of a Quality Systems Approach to Pharmaceutical cGMPs in Compliance with the FDA Guidance. This course will define the concepts behind the application of the Quality Systems to drug operations and the specific elements as discussed on the FDA guideline: Quality Systems Approach to Pharmaceutical cGMP Regulations.

Methods Validation

Mon, 22 Dec 2008 13:23:32 GMT
May 4 - 6, 2009

Developing a Moist Heat Sterilization Program within FDA Requirements

Tue, 04 Nov 2008 11:13:15 GMT
June 2-4, 2010

Cleaning Validation

Wed, 29 Oct 2008 15:22:26 GMT
April 7-9, 2010

Environmental Mycology Identification Workshop

Thu, 09 Oct 2008 10:06:38 GMT
May 5-7, 2010

Developing an Environmental Monitoring Program

Thu, 09 Oct 2008 08:49:36 GMT
March 10-12, 2010

Detecting Microbial Contamination Using Rapid Microbiological Methods

Thu, 09 Oct 2008 08:28:15 GMT
N/A

Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems

Thu, 16 Oct 2008 15:05:35 GMT
March 25-26, 2009

Rapid Microbiological Methods

Tue, 04 Nov 2008 15:15:08 GMT
August 2-6, 2010
This five-day workshop offers you a unique opportunity to evaluate several different Rapid Microbiological Systems in a laboratory-based environment.

Standard Training Course Time Schedule

Fri, 13 Mar 2009 16:46:07 GMT
N/A

In-House Training

Wed, 18 Mar 2009 12:28:38 GMT
PDA TRI can work with you to bring custom training solutions and expert instructors right to your doorstep.

PDA Training and Research Institute Discounts

Fri, 05 Jun 2009 13:03:34 GMT
N/A

2010 Boston Course Series

Mon, 23 Nov 2009 13:58:47 GMT
May 24 - 26, 2010 5 Pharmaceutical and Biopharmaceutical courses straight from the experts.

2010 PDA Biennial Training Conference Course Series

Tue, 01 Dec 2009 10:55:24 GMT
October 14-15, 2010 The PDA Training and Research Institute (PDA TRI) will offer 4 courses to immediately follow the 2010 PDA Biennial Training Conference.

On-Demand Web Seminars

Thu, 02 Oct 2008 13:02:47 GMT
N/A

Designing a Cleaning and Disinfection Program in GMP Controlled Environments

Thu, 02 Oct 2008 13:46:23 GMT
N/A

Web Seminars

Mon, 29 Sep 2008 12:02:30 GMT
N/A

Reducing the Burden of Equipment Cleaning by Employing Risk & SPC Based

Tue, 26 Jan 2010 15:01:30 GMT
February 17, 2010
In this case study we will show how existing CIP cycles were optimized by employing statistical process control techniques to reduce water, time and chemical requirements. Further optimizations were realized by employing risk based techniques to group and better sequence cleaning circuits. We found that it was possible to realize annual WFI reductions of 90%. Not only does this greatly reduce utility and chemical costs, but it frees up valuable capacity for additional manufacturing. In addition, with the movement towards more sustainable corporate citizenry and 'greener' operations, optimized equipment cleaning regimes can reduce a facility's carbon footprint by 1000's of tons of CO2. Effective equipment cleaning programs represent a prime opportunity for furthering a facility's operational excellence

Development and Validation of an Integrity Test Method for Large Volume 3D Bag Chambers

Tue, 26 Jan 2010 14:49:37 GMT
February 17, 2010
This web seminar will discuss large volume single-use 3D bags that are increasingly used for the storage, processing and shipping of high value products, such as bulk drug substances and vaccines. Large volume 3D bags are also used to support continuous cell culture processes, specifically for media preparation and storage. For these critical applications, it is important to test the integrity of the flexible containers before use to prevent ingress of microbial contamination. This presentation will focus on a non-destructive, 100% on-line package integrity testing method, incorporated in a 3D bag production line. The performances of the integrity test will be discussed, with an emphasis on the methods developed to verify the ability of the flexible containers to meet the established leak rate specifications. Correlation between the liquid leak, microbial ingress, pinhole size and testing sensitivity will be reviewed

Fundamentals of Lyophilization in Syringes

Tue, 26 Jan 2010 14:51:41 GMT
March 11, 2010
This web seminar will compare and give an overview of the lyophilization in syringe vs. vial, as well as discuss challenges involved in freeze-dried products in syringes. It will describe the standard commercial filling and lyophilization equipment that was utilized and the modifications that were required to successfully perform lyophilization in pre-filled syringes. The lyophilization cycle development will be discussed and compared to similar products lyophilized in vials. Challenges such as stopper placement and the significance of stopper placement will be discussed. Validation of the process with media fills will be considered. The feasibility of dual chamber syringes with lyo and diluent will be presented.

Environmental Monitoring in Isolators

Tue, 26 Jan 2010 14:14:24 GMT
March 9, 2010
During this web seminar, we will be exploring the following:

Fundamental principles
Current EM Approaches and Practices
Sampling Frequency or Intensity
Surface and "Personnel" Monitoring
Monitoring Targets
Trends
The Myth of Aseptic Sterility Assurance
Symptoms of Absolutism

Process Validation Excellence - It's Simple as 1, 2, 3

Tue, 26 Jan 2010 14:30:27 GMT
February 16, 2010
This discussion will address the impact of recent industry initiatives with a focus on the new FDA (draft) Guidance for Process Validation. The new guidance builds upon the concepts of the 1987 guidance and emphasizes a 3 stage lifecycle approach. By implementing tools for each validation stage, firms can develop a compliant and science based program as simply as 1, 2, 3. Industry has generally focused process validation efforts on three qualification lots. It is clear that process validation now extends far beyond testing process streams for yield and purity to include concepts such as Critical Process Parameters, multivariate analysis, orthogonal analytical methods, justified acceptance criteria and statistical analysis

Development and Validation of an Integrity Test Method for a Sterile Connection Device: Correlation of Integrity Test Limits to Loss of Integrity of Devices

Tue, 26 Jan 2010 13:54:12 GMT
March 2, 2010
Disposables are known to offer a variety of advantages to users within biopharmaceutical manufacturing. The adoption of disposable systems requires suppliers to provide the industry with adequate disposable alternatives of existing, non disposable technologies. Sartorius Stedim Biotech developed a new connector for sterile fluid transfer that has been qualified applying the most stringent and innovative test regimes. This presentation will focus on the development and validation of an integrity test method for the Opta SFT sterile connector.

Adopting ICH Q10 to Achieve Competitive Compliance

Tue, 26 Jan 2010 13:42:47 GMT
February 11, 2010
This web seminar provides compelling reasons why and how industry should adopt and implement ICH Q10. Many pharmaceutical companies still find it difficult to devise a business case, and overwhelmed by the daily business, implementation is almost always postponed.

Pharmaceutical Water Mythology

Tue, 26 Jan 2010 12:50:10 GMT
February 9, 2010
This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies.

Knowledge Management: Application of Project Management and Program Management Best Practices to Lean Manufacturing and Lean Laboratory Projects

Thu, 10 Dec 2009 17:54:45 GMT
April 8, 2010
This web seminar explores the lean philosophy of one CMO. The audience will benefit from the lessons learned and case studies which will be presented within the paper.

Intrinsic Foreign Particulate Matter Identification and Application of ISO 16232 cleanliness testing procedures and qualified equipment to control and minimize foreign particulate matter in parenterals down to 1 µm.

Thu, 10 Dec 2009 17:33:30 GMT
March 31, 2010
This web seminar explores visible rejects and high quality production of parenterals it is crucial to detect foreign particles. Especially for the quite sensitive protein pharmaceuticals that can form agglomerates from particulate impurities. Several factors contribute to the release of foreign particles from certain surfaces such as the smoothness, the electrical charge and the geometry of the primary packaging material. The pharmaceutical industry should apply principles from the automotive industry and integrate reliable and reproducible parameters for quality cleanliness parts testing to determine the FPM levels of pre-fill-able syringes.

Implementation of QbD in downstream processes for plasma derived and recombinant proteins products

Thu, 10 Dec 2009 17:17:08 GMT
March 4, 2010
This web seminar explores how to increase the speed of development and the understanding of the Downstream Process of Biologicals (mainly others than Mabs), Design of Experiments (DoE) and other QbD tools are being implemented in LFB Biotechnologies.

Software Implementation in One Third of the Time and Cost

Fri, 11 Sep 2009 11:32:03 GMT
April 8, 2010
This web seminar explores proven techniques that reduce validation project time, often to one third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.

Automated Validation Lifecycle Management - A Working Model

Fri, 28 Aug 2009 16:54:15 GMT
May 13, 2010
This web seminar presents a platform that changes the status quo completely. The automated validation lifecycle management platform eliminates paper completely and changes the current paradigm. This platform increase efficiencies and thus while saving millions of dollars for the FDA regulated industry. Attendees will witness this paperless platform in action

Web Seminars Registration form

Tue, 26 May 2009 13:34:49 GMT
N/A

Efficiency Improvements in the Purification of Protein-Based Therapeutics Using Highly Specific Designed Affinity Ligands

Fri, 15 May 2009 12:54:19 GMT
October 1, 2009

Registration-New Technologies to Meet Temperature Challenges during Storage and Transportation

Sun, 05 Apr 2009 16:27:36 GMT
N/A

Registration-Thermal Vaidation

Sun, 05 Apr 2009 16:23:23 GMT
N/A

Registration-ExcelSpreadsheets

Sun, 05 Apr 2009 16:18:39 GMT
N/A

Registration_Optimal Cold Chain Management North American Distribution Networks

Sun, 05 Apr 2009 16:10:36 GMT
N/A

Registratationform_Process Analytical Technology-Case Study

Sun, 05 Apr 2009 16:03:45 GMT
N/A

Registration form - Automated Real-Time On-Line Measurement of Bacteria

Tue, 03 Mar 2009 12:20:55 GMT
N/A

Registration form - Paperless Validation, A Case Study

Fri, 30 Jan 2009 18:54:26 GMT
N/A

Registration form Excipients On Demand

Wed, 14 Jan 2009 12:26:36 GMT
Excipients On Demand

Registration Form - On Demand Recorded Webcast - Supply Chain

Tue, 30 Dec 2008 16:55:26 GMT
N/A

Registration form - Process Analytical Technology for the Automation of Quality Assurance and Control

Wed, 24 Dec 2008 15:45:46 GMT
N/A

Registration form - Quality System Framework Approach to Risk Management

Wed, 24 Dec 2008 15:43:51 GMT
N/A

Registration form - How do I Implement QbD?

Wed, 24 Dec 2008 15:34:35 GMT
N/A

02-19-2009 WS Registration Form

Wed, 17 Dec 2008 11:04:28 GMT
N/A

Registration form - Quality Oversight of Electronic Data & Computerized Systems

Tue, 16 Dec 2008 16:17:17 GMT
Reg form for Quality Oversight of Electronic Data & Computerized Systems

Registration Form - Supply Chain Web Seminar - new date

Tue, 09 Dec 2008 15:53:15 GMT
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Registration Form - Excipients

Mon, 08 Dec 2008 15:31:58 GMT
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Registration Form - Supply Chain Conference

Mon, 01 Dec 2008 10:00:46 GMT
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Registration Form - December 2008 Web Seminars

Wed, 26 Nov 2008 11:34:33 GMT
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FAQs

Mon, 11 Aug 2008 15:54:28 GMT
FAQs Online Learning

Online Learning Presentation Guidelines

Thu, 10 Jul 2008 13:32:57 GMT
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System Requirements

Tue, 16 Sep 2008 12:49:24 GMT
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Excipients: What You Need to Know from GMPs, GDPs and Beyond

Mon, 29 Sep 2008 12:27:10 GMT
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Microbial Failure Investigations - A Systematic Approach

Mon, 08 Sep 2008 16:10:44 GMT
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Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control

Fri, 26 Sep 2008 07:10:01 GMT
Join members of the PDA Task Force on PDA Technical Report No. 1 and industry representatives at the workshop on PDA Technical Report No. 1, 2007 Revision - Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control to discuss the recommendations in the 2007 revision. The product of new contributions and original text revisions by 40 contributors with scientific and regulatory backgrounds, the 2007 revision of PDA Technical Report No. 1 contains consensus scientific guidance and recommendations on how to establish a moist heat sterilization program that may be applied globally.

Featured Speakers

Fri, 17 Oct 2008 14:17:29 GMT
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Registration Fees

Tue, 14 Oct 2008 16:15:33 GMT
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Directions

Mon, 11 Aug 2008 15:52:07 GMT
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PDA_TR1_web_banner

Fri, 03 Oct 2008 10:57:44 GMT
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Agenda

Fri, 26 Sep 2008 14:09:54 GMT
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List of Area Hotels

Thu, 10 Jul 2008 13:27:34 GMT
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Registration Form

Fri, 26 Sep 2008 14:01:46 GMT
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PDA Canada Chapter 2008 Fall Dinner Conference, Quebec City

Thu, 25 Sep 2008 13:27:59 GMT
Topic Abstracts: Challenges in Today`s Regulated Supply Chain - Risks of Supply Chain, Securing Through Technology and Risk Based Qualification

PDA Canada Chapter 2008 Fall Dinner Conference, Montreal

Thu, 25 Sep 2008 13:14:51 GMT
Leveraging Commissioning Work and or Vendor Start Up into Equipment Qualification can save time and make compliance less painful. This session will explore the Commission and Qualification Baseline Guide and the ASTM Standard and how to apply them to meet the compliance goals while not performing repetitive work. But how do you apply it to maintain equipment and systems in regulated companies according to the ISPE Maintenance Baseline Guide? How do you apply maintenance and equipment repairs that are economic from a business sense as well as the regulated side of the business? We will drill deeper into the ISPE Baseline Guide for Maintenance and apply the principles learned from other baseline guides to adjust our maintenance

08_pda-ispe_pics_regform

Thu, 10 Jul 2008 12:52:01 GMT
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devprefilled2008nov

Thu, 18 Sep 2008 17:06:46 GMT
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DVCD - Course Brochure

Thu, 10 Jul 2008 13:15:14 GMT
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Training Workshop on PDA Technical Report No.1, Revised 2007

Mon, 15 Sep 2008 12:06:04 GMT
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Jianguo Garden Hotel

Thu, 18 Sep 2008 14:41:03 GMT
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Agenda

Mon, 08 Sep 2008 16:07:18 GMT
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Training Workshop on PDA Technical Report No. 26, Revised 2008

Mon, 15 Sep 2008 11:51:13 GMT
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Jianguo Garden Hotel

Thu, 18 Sep 2008 14:41:03 GMT
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Agenda

Mon, 08 Sep 2008 16:07:33 GMT
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Training Workshop on PDA Technical Report No. 26, Revised 2008

Mon, 08 Sep 2008 16:07:26 GMT
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PDA Conference on the Development and Regulation of Clinical Trial Supplies

Mon, 15 Sep 2008 11:08:49 GMT
The fastest growing sector in the pharmaceutical industry is biologics. "Quality by Design (QbD)" and "The process is the product" have become long-time mottos for the regulators and companies developing new medicinal products also in this segment of the industry. Increased use of a wide variety of new technologies and expression systems makes GMP practices even more difficult to apply. Earlier stages of development and advancement of the product lifecycle through clinical stages to marketing can cause confusion about the regulatory status, since three branches of the Food and Drug Administration (FDA) are involved: the Center for Biologics Evaluation and Research (CBER); the Center for Drug Evaluation and Research (CDER); and the Office of Regulatory Affairs (ORA). In addition, compliance with international regulatory agencies is increasingly becoming a challenge.

Speaker Biographies

Mon, 20 Oct 2008 14:42:45 GMT
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Hyatt Cambridge

Wed, 24 Sep 2008 18:33:43 GMT
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Agenda

Mon, 08 Sep 2008 15:29:42 GMT
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Registration Fees

Mon, 08 Sep 2008 15:29:48 GMT
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Networking Opportunities

Mon, 08 Sep 2008 15:29:54 GMT
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Exhibitors and Sponsorships

Thu, 18 Sep 2008 22:19:42 GMT
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Program Committee

Mon, 08 Sep 2008 15:30:06 GMT
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Venue

Mon, 08 Sep 2008 15:30:19 GMT
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Continuing Education Credits

Mon, 08 Sep 2008 15:30:25 GMT
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Recommended Reading

Mon, 08 Sep 2008 15:30:31 GMT
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Brochure

Thu, 18 Sep 2008 16:49:50 GMT
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Banner

Thu, 18 Sep 2008 21:56:57 GMT
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Hyaluron Contract Manufacturing Tour/Open House

Mon, 08 Sep 2008 16:04:21 GMT
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Pharmaceutical Freeze Drying Technology

Mon, 15 Sep 2008 10:39:20 GMT
This is the abstract.

Registration Fees

Mon, 08 Sep 2008 15:32:04 GMT
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Networking Opportunities

Mon, 08 Sep 2008 15:32:10 GMT
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Exhibition and Sponsorship

Tue, 16 Sep 2008 11:50:45 GMT
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Program Committee

Mon, 08 Sep 2008 15:32:23 GMT
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PDA TRI Training Courses

Mon, 08 Sep 2008 15:32:29 GMT
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Venue

Mon, 08 Sep 2008 15:32:35 GMT
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Continuing Education Credit

Mon, 08 Sep 2008 15:32:41 GMT
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Recommended Readings

Mon, 08 Sep 2008 15:32:47 GMT
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Brochure

Thu, 10 Jul 2008 12:48:50 GMT
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Agenda

Thu, 10 Jul 2008 12:48:46 GMT
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Banner Image

Wed, 17 Sep 2008 08:54:47 GMT
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More Training Course Info

Wed, 17 Sep 2008 09:25:16 GMT
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On-Demand Web Seminar

Fri, 05 Sep 2008 12:09:02 GMT
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Process Validation of Protein Manufacturing - PDA Technical Report No. 42

Mon, 11 Aug 2008 16:38:16 GMT
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Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals, PDA TR-28 2006 Revision - Interpretation and Perspectives

Mon, 11 Aug 2008 17:18:24 GMT
01/31/2008

EU Regulations: An Overview

Mon, 11 Aug 2008 17:18:19 GMT
01/17/2008

FDA's "Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production" - An Overview

Mon, 11 Aug 2008 17:15:19 GMT
11/15/2007

Technical Report No. 1: Process Performance Qualification (Section 5)

Mon, 11 Aug 2008 16:59:50 GMT
08/21/2007

Technical Report No. 1: Sterilization Process Development (Section 4)

Mon, 11 Aug 2008 16:59:45 GMT
08/07/2007

Technical Report No. 1: Sterilization Science and Technology (Section 3)

Mon, 11 Aug 2008 16:59:39 GMT
07/25/2007

Pharmacy Compounding - Potential Impact on Pharmaceutical Manufacturers

Mon, 11 Aug 2008 17:25:17 GMT
03/06/2008

The Closed Vial Technology: A New Concept in Aseptic Filling to Increase Patient Safety

Mon, 11 Aug 2008 16:50:05 GMT
04/19/2007

Parametric Release of Drug Products Terminally Sterilized by Moist Heat

Mon, 11 Aug 2008 16:33:39 GMT
01/18/2007

Oversight Program for Transport Providers of Shipments of Temperature Sensitive Products

Mon, 11 Aug 2008 16:58:39 GMT
07/12/2007

Online Liquid Chromatography as a PAT in Biotech Process Development and Manufacturing

Mon, 11 Aug 2008 16:36:44 GMT
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Qualifying Operators in their Jobs

Mon, 11 Aug 2008 17:28:57 GMT
05/08/2008

Quality in Healthcare - Anticipation and Management

Mon, 11 Aug 2008 16:35:26 GMT
02/01/2007

FDA Final Guidance: Investigating Out of Specification Test Results

Mon, 11 Aug 2008 16:43:42 GMT
03/08/2007

Designing a Cleaning and Disinfection Program in GMP Controlled Environments

Mon, 11 Aug 2008 16:01:31 GMT
11/15/2006

Applying Lean Six Sigma Principles to Environmental Monitoring Processes

Mon, 11 Aug 2008 16:46:29 GMT
04/26/2007

The Universe of Pre-Filled Syringes and Injection Devices

Wed, 03 Sep 2008 16:37:06 GMT
October 6-7, 2008 | San Diego, California

Speaker Bios

Tue, 14 Oct 2008 13:46:48 GMT
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Registration Form

Thu, 18 Sep 2008 16:58:32 GMT
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Brochure

Fri, 26 Sep 2008 15:40:18 GMT
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Hard Rock San Diego

Thu, 18 Sep 2008 08:35:31 GMT
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Hyatt San Diego

Thu, 18 Sep 2008 08:31:06 GMT
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Registration Fees

Wed, 03 Sep 2008 17:27:22 GMT
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Networking Opportunities

Wed, 03 Sep 2008 17:29:34 GMT
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Exhibition and Sponsorship

Wed, 17 Sep 2008 13:09:50 GMT
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Program Committee

Fri, 12 Sep 2008 11:50:38 GMT
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bd_sponsor

Thu, 10 Jul 2008 09:26:04 GMT
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Gary Hall Jr. Press Release

Wed, 17 Sep 2008 14:53:01 GMT
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gary_hall_full

Thu, 10 Jul 2008 09:26:57 GMT
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Agenda

Wed, 03 Sep 2008 17:05:22 GMT
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Gary Hall photo

Wed, 03 Sep 2008 16:58:39 GMT
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pre-filled banner

Wed, 03 Sep 2008 16:54:45 GMT
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Venue

Thu, 18 Sep 2008 08:26:26 GMT
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Continuing Education Credit

Wed, 17 Sep 2008 15:17:58 GMT
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About Gary Hall Jr.

Thu, 10 Jul 2008 09:29:43 GMT
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2009 PDA Annual Meeting

Mon, 11 Aug 2008 15:30:40 GMT
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Exhibitor logos

Mon, 13 Apr 2009 10:38:09 GMT
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2010 PDA Annual Meeting

Fri, 20 Mar 2009 07:28:19 GMT
Manufacturing Excellence
March 15-19, 2010 | Orlando, Florida

PDA Workshop: Cleanroom Technology and Contamination Control

Sat, 08 Nov 2008 11:33:54 GMT
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Workshop on FDA's New Guidance on Process Validation

Thu, 18 Dec 2008 10:59:11 GMT
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Brochure

Wed, 08 Oct 2008 15:14:17 GMT
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Test Banner

Tue, 02 Dec 2008 10:48:51 GMT
Banner that is longer and allows for messaging on the far right...

Registration Form

Wed, 26 Nov 2008 15:45:22 GMT
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Networking Events Registration Form

Wed, 04 Feb 2009 16:11:03 GMT
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Message from the Program Chair

Thu, 06 Nov 2008 14:11:56 GMT
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Agenda

Wed, 05 Nov 2008 12:31:40 GMT
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Keynote Speakers

Mon, 06 Oct 2008 15:38:54 GMT
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FDA-Speakers

Mon, 06 Oct 2008 15:07:18 GMT
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Registration Fees

Mon, 11 Aug 2008 17:37:26 GMT
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2009 PDA Annual Meeting: Exhibition and Sponsorships

Fri, 19 Sep 2008 13:58:00 GMT
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Networking Opportunities

Wed, 18 Mar 2009 08:14:34 GMT
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PDA's 5th Annual Career Fair

Tue, 21 Oct 2008 10:21:37 GMT
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Program Committee

Mon, 11 Aug 2008 17:37:42 GMT
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Venue

Mon, 11 Aug 2008 17:37:53 GMT
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Continuing Education Credit

Mon, 11 Aug 2008 17:37:58 GMT
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Recommended Reading

Mon, 11 Aug 2008 17:38:04 GMT
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Red Rock Hotel

Sun, 21 Sep 2008 12:25:06 GMT
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2009 Banner

Fri, 05 Sep 2008 12:38:05 GMT
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2008 PDA Conference on Quality by Design

Mon, 11 Aug 2008 15:30:11 GMT
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How to Handle out of Specification Results - A Comprehensive Guide to OOS Regulations

Thu, 18 Sep 2008 11:12:22 GMT
PDA #500 | ACPE #116-000-05-500-L04-P | 0.6 CEUs Location: Frankfurt/Offenbach, Germany Date: 6 October Duration: 1 day Time: 09:00 - 17:00

Sheraton Frankfurt

Wed, 24 Sep 2008 17:29:25 GMT
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08-pda-qbd-agenda

Thu, 18 Sep 2008 16:58:01 GMT
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Message From the Chair

Thu, 10 Jul 2008 12:54:05 GMT
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Brochure

Thu, 10 Jul 2008 12:54:01 GMT
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Registration Fees

Mon, 11 Aug 2008 17:33:39 GMT
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Networking Opportunities

Mon, 11 Aug 2008 17:33:45 GMT
N/A

Exhibition and Sponsorship

Thu, 18 Sep 2008 08:59:15 GMT
N/A

Program Committee

Mon, 11 Aug 2008 17:33:56 GMT
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Venue

Mon, 11 Aug 2008 17:34:07 GMT
N/A

Continuing Education Credits

Mon, 11 Aug 2008 17:34:12 GMT
N/A

Recommended Readings

Mon, 11 Aug 2008 17:34:17 GMT
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Calls for Papers-Posters

Fri, 07 Nov 2008 04:47:23 GMT
Any open calls for papers or posters for upcomming conferences.

Sterilization Technology Today and Tomorrow

Mon, 22 Dec 2008 14:09:23 GMT
November 18-19, 2009
The Sterilization Technology Today and Tomorrow conferences will review existing and future technologies for the sterilization of materials, components and finished products in the healthcare industry. Presentations from industry and regulatory experts will cover the range of available technologies in current use, along with expected new approaches for the manufacture of sterile products.

Continuing Education Credit

Tue, 26 May 2009 15:45:48 GMT
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Message from the Program Chairs

Tue, 26 May 2009 15:42:48 GMT
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Brochure

Wed, 04 Feb 2009 11:39:03 GMT
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Exhibition and Sponsorships

Tue, 27 Jan 2009 11:24:31 GMT
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Agenda

Mon, 26 Jan 2009 10:48:37 GMT
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Registration Fees

Tue, 06 Jan 2009 11:54:44 GMT
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Program Invited Presenters

Wed, 21 Jan 2009 12:14:21 GMT
List of Invited Presenters for the Sterilization Technology Today and Tomorrow Conference Series.

Program Planning Committee

Thu, 08 Jan 2009 11:39:50 GMT
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Registration Form

Tue, 13 Jan 2009 12:59:05 GMT
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Venue

Mon, 29 Dec 2008 15:29:19 GMT
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Workshop on FDA's New Guidance on Process Validation

Mon, 29 Dec 2008 13:40:01 GMT
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Workshop on FDA's New Guidance on Process Validation

Wed, 24 Dec 2008 10:49:16 GMT
November 20, 2009
FDA representatives who were actively involved in the preparation of the draft Process Validation: General Principles and Practices have been invited to provide their perspective on the approaches taken, and a representative of FDA's office of Regulatory Affairs has been asked to discuss what investigators will expect when they come into your plants for an inspection.

Brochure

Tue, 20 Oct 2009 10:32:21 GMT
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Program Planning Committee

Tue, 20 Oct 2009 10:31:28 GMT
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Continuing Education Credit

Tue, 20 Oct 2009 10:29:57 GMT
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Agenda

Mon, 26 Jan 2009 11:59:59 GMT
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Selection and Implementation of Advanced Aseptic Processing Techniques

Wed, 14 Jan 2009 13:39:05 GMT
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Registration Form

Tue, 13 Jan 2009 12:55:17 GMT
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Venue

Thu, 08 Jan 2009 15:35:23 GMT
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Registration Fees

Tue, 06 Jan 2009 11:37:15 GMT
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Sterilization Technology Today and Tomorrow

Mon, 29 Dec 2008 12:07:56 GMT
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Exhibition and Sponsorships

Wed, 24 Dec 2008 11:25:09 GMT
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