Global Event Calendar and Registration

New England Chapter - CGMP Compliant Personnel Training Systems

Mon, 19 Jul 2010 11:24:36 GMT

N/A

PDA Australia: Good Distribution Practice

Tue, 06 Jul 2010 09:29:28 GMT

N/A

PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop

Wed, 23 Jun 2010 11:04:41 GMT

This workshop is being organized as a result of viral contamination events that have occurred in the past few years. The Parenteral Drug Association (PDA), along with the FDA, wants to encourage modernization in the industry with respect to viral detection and control measures; the goal is to discuss gaps in our current ability to detect, control and clear adventitious viruses; to discuss availability of emerging technologies in areas where gaps exist; to clarify CGMP expectation for adventitious virus detection and control and consequences for non compliance.

Venue

Thu, 15 Jul 2010 12:23:10 GMT

N/A

Registration Fees

Wed, 23 Jun 2010 13:40:47 GMT

N/A

Registration Form

Wed, 23 Jun 2010 13:39:21 GMT

N/A

2010 Student Night - Awards to the research scientists of tomorrow!

Wed, 26 May 2010 16:47:29 GMT

N/A

NEPDA December 2010 Business Meeting

Wed, 19 May 2010 15:55:59 GMT

N/A

NEPDA October 2010 Business Meeting

Wed, 19 May 2010 15:43:27 GMT

N/A

NEPDA June 2010 Business Meeting

Wed, 19 May 2010 15:29:31 GMT

N/A

2010 Southeast Chapter Golf Social

Wed, 19 May 2010 14:59:01 GMT

N/A

West Coast Chapter: Virus Contamination of Cell Culture Manufacturing Operations - A Question of When, Not If

Wed, 19 May 2010 13:56:44 GMT

N/A

Mountain States Chapter Aseptic Processing & Autoclave Validation Seminars

Mon, 17 May 2010 13:32:56 GMT

N/A

PDA Technical Report Workshop: Moist Heat Sterilizer Systems, Steam in Place and Parametric Release of Pharmaceutical and Medical Device Products Terminally Sterilized by Moist Heat

Thu, 13 May 2010 14:03:56 GMT

N/A

Program Agenda

Tue, 13 Jul 2010 12:44:26 GMT

N/A

Registration Form

Mon, 24 May 2010 08:15:46 GMT

N/A

Venue

Thu, 13 May 2010 15:43:02 GMT

N/A

Registration Fees

Thu, 13 May 2010 14:30:11 GMT

N/A

PDA Workshop on Aseptic Processing: Issues and Approaches

Mon, 10 May 2010 08:34:21 GMT

In May of 2008, PDA conducted a memorable and successful symposium on Risk Management and Aseptic Processing, to present methods to better understand the challenges of aseptically manufacturing sterile products. This November 15th and 16th 2010, PDA will continue its exploration of better methods for meeting those challenges by bringing together industry experts and regulators to present, listen to, and clarify ideas during its Aseptic Processing: Issues and Approaches Workshop

Agenda

Thu, 22 Jul 2010 12:29:02 GMT

N/A

Registration Form

Mon, 24 May 2010 08:16:28 GMT

N/A

Venue

Thu, 13 May 2010 14:55:49 GMT

N/A

Registration Fees

Wed, 12 May 2010 12:29:31 GMT

N/A

PDA Delaware Valley Chapter, Overview of CMC Regulatory Submissions

Fri, 16 Apr 2010 14:41:13 GMT

N/A

May 24th 2010 Supply Chain - Intro to RX360 at SoCal Chapter of PDA

Thu, 15 Apr 2010 15:24:27 GMT

N/A

Assessing Risks of Changing Sterile Drug Manufacturing Sites

Mon, 12 Apr 2010 15:09:08 GMT

N/A

Web Seminars

Wed, 07 Apr 2010 16:28:18 GMT

N/A

Exhibit and Sponsorship

Wed, 07 Apr 2010 16:29:20 GMT

N/A

PDA UK Chapter Presents: Disinfection - Latest Trends

Tue, 06 Apr 2010 10:06:43 GMT

N/A

Australia Chapter: Quality Risk Management - Effective Implementation

Tue, 30 Mar 2010 11:29:01 GMT

N/A

Contamination, Control, Inactivation & Removal

Fri, 26 Mar 2010 08:34:32 GMT

N/A

Technological Advances to Improve Laboratory and In-Process Analysis Time

Fri, 19 Mar 2010 15:55:40 GMT

N/A

Pre-filled Syringe Interest Group Workshop

Tue, 16 Mar 2010 11:08:29 GMT

N/A

Agenda

Tue, 20 Apr 2010 14:15:59 GMT

N/A

Venue

Mon, 29 Mar 2010 15:07:54 GMT

N/A

Registration Fees

Tue, 16 Mar 2010 15:39:13 GMT

N/A

Registration Form

Tue, 16 Mar 2010 15:38:13 GMT

N/A

Pre-filled Interest Group Workshop Flyer

Tue, 16 Mar 2010 11:26:42 GMT

N/A

2011 PDA Annual Meeting

Fri, 05 Mar 2010 15:03:18 GMT

N/A

Registration Form

Thu, 03 Jun 2010 14:58:34 GMT

N/A

Venue

Wed, 02 Jun 2010 10:18:16 GMT

N/A

Registration Fees

Fri, 14 May 2010 11:27:28 GMT

N/A

Exhibition and Sponsorships

Tue, 11 May 2010 13:17:48 GMT

N/A

PDA Southeast Chapter 2010 Spring Conference: Emerging Regulatory and Compliance Topics

Tue, 09 Feb 2010 08:15:33 GMT

Annual Spring Conference addressing the HOT Topics of 2010! Tuesday, April 13th at BTEC on NCSU's Centinnial Campus.

Sterility Assurance Risk Management

Tue, 02 Feb 2010 08:28:06 GMT

Gloria Berrios of Eli Lilly & Co. will share how sterility assurance risk management was recently revamped at Lilly's parenteral manufacturing facility in Indianapolis and benchmark how the Lilly program compares to similar programs conducted at other firms.

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

DC Venue

Mon, 29 Mar 2010 15:54:23 GMT

N/A

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

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.

Request a Brochure

Fri, 23 Jul 2010 08:57:04 GMT

N/A

cover

Thu, 15 Jul 2010 16:21:50 GMT

N/A

PDF Brochure - Current as of 7/13, For Most Current Information, See Agenda

Wed, 14 Jul 2010 13:06:59 GMT

N/A

justification cover

Thu, 01 Jul 2010 12:18:08 GMT

N/A

Justification Letter

Tue, 29 Jun 2010 13:34:04 GMT

N/A

USP logo

Mon, 14 Jun 2010 16:24:33 GMT

N/A

Agenda

Tue, 08 Jun 2010 17:45:07 GMT

N/A

Exhibition and Sponsorships

Tue, 11 May 2010 13:11:32 GMT

N/A

Venue

Fri, 05 Feb 2010 11:22:31 GMT

N/A

Microbiology Conference PDA TRI Course Series

Wed, 03 Feb 2010 13:34:46 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

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.

Venue

Wed, 23 Jun 2010 15:20:57 GMT

N/A

Agenda

Mon, 17 May 2010 16:14:25 GMT

N/A

PDA TRI Course: Fundamentals of Lyophilization

Tue, 27 Apr 2010 14:33:13 GMT

N/A

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.

Request a Brochure

Tue, 06 Jul 2010 11:26:45 GMT

N/A

brochure cover

Tue, 06 Jul 2010 11:24:29 GMT

N/A

PDF Brochure - Current as of 6/24/10, for Most Current Information, See Agenda

Thu, 01 Jul 2010 08:17:11 GMT

N/A

Justification Letter

Mon, 14 Jun 2010 07:55:19 GMT

N/A

Continuing Education Credit

Tue, 01 Jun 2010 15:18:46 GMT

N/A

Agenda

Thu, 27 May 2010 13:19:44 GMT

N/A

Keynote Ballot

Wed, 17 Mar 2010 10:43:27 GMT

N/A

The Universe of Pre-filled Syringes and Injection Devices Course Series

Tue, 23 Feb 2010 14:36:39 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 and Leachables Workshop

Tue, 08 Dec 2009 15:35:40 GMT

N/A

flyer-cover

Mon, 26 Jul 2010 15:50:13 GMT

N/A

Flyer

Thu, 15 Jul 2010 15:15:53 GMT

N/A

2010 PDA/FDA Joint Regulatory Conference Courses

Thu, 27 May 2010 10:51:03 GMT

N/A

PDF Brochure - Current as of 5/18/10, For Most Current Information See Agenda

Thu, 27 May 2010 10:45:12 GMT

N/A

Interactive Brochure - Current as of 5/18/10, for Most Current Information, See Agenda

Thu, 27 May 2010 10:43:27 GMT

N/A

Agenda

Thu, 06 May 2010 14:35:45 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

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 Dinner Meeting and Facility Tour - Maintaining Supply Chain Security

Thu, 08 Oct 2009 11:24:53 GMT

N/A

NEPDA Presents: The Last Mile: PDA Tech Report 46, and "Avoiding Logistical Nightmares"

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.

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.

Request a Brochure

Thu, 15 Jul 2010 16:23:47 GMT

N/A

hamburg-photo

Mon, 12 Jul 2010 16:08:37 GMT

N/A

Justification Letter

Fri, 11 Jun 2010 16:26:09 GMT

N/A

PDA/FDA Joint Regulatory Conference

Tue, 01 Jun 2010 17:04:46 GMT

N/A

Continuing Education Credit

Tue, 01 Jun 2010 15:15:09 GMT

N/A

cover

Thu, 20 May 2010 15:59:35 GMT

N/A

Request a Brochure

Thu, 20 May 2010 15:54:56 GMT

N/A

Interactive Brochure - Current as of 5/18/10, for Most Current Information, See Agenda

Thu, 20 May 2010 15:50:01 GMT

N/A

PDF Brochure - Current as of 5/18/10, For Most Current Information See Agenda

Wed, 19 May 2010 09:24:43 GMT

N/A

Agenda

Mon, 03 May 2010 13:39:23 GMT

N/A

2010 PDA/FDA Joint Regulatory Conference Courses

Fri, 26 Mar 2010 11:39:21 GMT

N/A

Registration Fees

Mon, 15 Feb 2010 14:10:30 GMT

N/A

Registration Form

Mon, 15 Feb 2010 14:09:22 GMT

N/A

2010 PDA Extractables and Leachables Workshop

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

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 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.

Interactive Brochure - Current as of 6/10/10, for Most Current Information, See Agenda

Thu, 17 Jun 2010 09:24:39 GMT

N/A

borchure cover

Thu, 17 Jun 2010 09:11:55 GMT

N/A

Request a Brochure

Thu, 17 Jun 2010 09:05:03 GMT

N/A

PDF Brochure - Current as of 6/10/10, for Most Current Information, See Agenda

Fri, 11 Jun 2010 10:36:39 GMT

N/A

Breakout Session Selection Sheet

Thu, 10 Jun 2010 12:55:51 GMT

N/A

Agenda

Thu, 20 May 2010 16:49:17 GMT

N/A

Continuing Education Credit

Fri, 14 May 2010 09:35:43 GMT

N/A

justify-cover

Mon, 03 May 2010 09:49:17 GMT

N/A

Justification Letter

Thu, 29 Apr 2010 10:04:29 GMT

N/A

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

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

About PDA Conferences

Fri, 07 Nov 2008 04:55:27 GMT

N/A

European Events

Thu, 06 Nov 2008 04:11:57 GMT

N/A

NEW! PDA Post-Conference Training Course: Development of a Freeze Drying Process

Tue, 20 Jul 2010 12:01:56 GMT

N/A

Interest Group Meeting Pre-filled Syringes

Mon, 19 Jul 2010 06:07:07 GMT

N/A

NEW! PDA Trainings Course: Contract Manufacturing

Mon, 19 Jul 2010 05:33:58 GMT

N/A

NEW! PDA Trainings Course: Parenterals 2010 - Integrating Process, Technology and Regulation

Mon, 19 Jul 2010 05:21:33 GMT

N/A

PDA Workshop on Contract Manufacturing

Fri, 28 May 2010 14:10:23 GMT

30 Nov - 1st Dec, 2010 | Amsterdam, The Netherlands

Workshop on Near IR - Manufacturing Uses & Recent Regulatory Guidance

Fri, 28 May 2010 13:56:57 GMT

November 22, 2010 | Vienna, Austria

2010 Pharmaceutical Freeze Drying Technology: Modern Trends in Production

Tue, 25 May 2010 12:22:35 GMT

November 23-24, 2010 | Vienna, Austria Freeze Drying is one of the most popular routes for stability enhancement of temperature sensitive products. Even though it has been used in...

PDA Workshop on Analytical Method and Procedure Validation: - An In-depth Review of the Global Requirements Governing Test Method and Procedure Development and Validation

Thu, 20 May 2010 05:24:29 GMT

November 11-12, 2010 | Vienna, Austria This Workshop will provide participants with an in-depth review of the laboratory and documentary standards providing guidance on...

PDA Training Course: An Introduction to Visual Inspection

Fri, 07 May 2010 10:45:52 GMT

N/A

PDA Presents a Series of Biopharmaceutical Events in Europe!

Wed, 05 May 2010 16:43:08 GMT

N/A

2010 PDA Europe Conference: Modern Biopharmaceutical Manufacturing - Current Best Practice

Thu, 15 Apr 2010 08:39:44 GMT

December 7-8, 2010 | Paris, France This pan-European Conference closes out PDA's 2010 scientific and educational offerings with a survey of the science and...

PDA Europe Workshop on Lean Manufacturing

Wed, 14 Apr 2010 04:32:39 GMT

September 21-22, 2010 | Dublin, Ireland

NEW! PDA Training Course: Good Distribution Practice

Wed, 24 Mar 2010 12:57:46 GMT

N/A

Parenterals 2010: Integrating Process, Technology and Regulation

Fri, 26 Feb 2010 06:39:19 GMT

October 26-28, 2010 | Berlin, Germany

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

2010 PDA Europe Visual Inspection Forum

Thu, 17 Dec 2009 06:10:34 GMT

N/A

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

Fri, 11 Dec 2009 08:51:10 GMT

7-8 October, 2010 | Berlin, Germany

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

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/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

Conference Program Planning Committees

Mon, 11 Aug 2008 15:54:34 GMT

N/A

Chapter Events

Tue, 28 Oct 2008 10:49:08 GMT

N/A

5th Annual PDA Metro Chapter Day Symposium: "Compliance in the New Decade of FDA Enforcement"

Wed, 24 Feb 2010 09:52:58 GMT

Featuring Jim Agalloco, Ellen Moskowitz, Kelli Dobilas, Robert Seltzer, Joel Schwartzman, and Radhakrishna S. Tirumalai. Last day to register is April 2, 2010.

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

Developing a Robust Supplier Management Process

Tue, 15 Jun 2010 14:42:19 GMT

November 4, 2010 Participants will be familiar with current regulatory expectations regarding supplier management and be able to implement these concepts in their own company to reduce the risks associated with supplier management.

Specialized Courses

Thu, 20 May 2010 11:05:57 GMT

N/A

Aseptic Courses

Thu, 20 May 2010 11:04:05 GMT

N/A

Quality Courses

Thu, 20 May 2010 11:02:09 GMT

N/A

Microbiology Courses

Tue, 18 May 2010 15:59:16 GMT

N/A

Training Courses

Tue, 18 May 2010 15:57:33 GMT

N/A

2010 Biotechnology Courses

Fri, 14 May 2010 15:33:52 GMT

N/A

The PDA Training and Research Institute Presents

Thu, 13 May 2010 14:25:01 GMT

N/A

Developing the Regulatory Rationale for the Reduction of Environmental and Utility Testing within an Environmental Monitoring Program

Wed, 12 May 2010 17:49:41 GMT

September 28-29, 2010

2010 Validation Courses

Wed, 05 May 2010 14:30:47 GMT

N/A

Computer Product Supplier Auditing Process Model: Auditor Training

Thu, 01 Apr 2010 17:12:22 GMT

September 30 - October 1, 2010 This two-day course provides specific auditor training in all phases of the audit cycle outlined in the PDA process model: Audit initiation, Preparation and pre-work, Conducting the audit, Observations and reporting, Decision-making, Follow-up and close-out.

Basic Microbiology for Aseptic Processes

Wed, 31 Mar 2010 11:25:40 GMT

N/A

2010 PDA/FDA Joint Regulatory Conference Course Series

Fri, 19 Mar 2010 14:05:27 GMT

N/A

Fundamentals of Lyophilization

Mon, 08 Mar 2010 14:46:54 GMT

This course is designed for participants to develop an understanding of the basic principles and practical aspects of lyophilization technology.

Six Sigma in Process Validation

Mon, 08 Mar 2010 14:42:09 GMT

This one day course will introduce the class to six sigma DMAIC tools and how they can be used in Commissioning, Qualification and Validation.

Writing Standard Operating Procedures

Mon, 08 Mar 2010 14:37:35 GMT

This one day interactive course will provide an overview of the requirements for Standard Operating Procedures and the rationale for their development and implementation.

Bioassay Development and Validation

Mon, 22 Feb 2010 17:06:21 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, 22 Feb 2010 17:01:04 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 - Expanded

Mon, 22 Feb 2010 16:54:35 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.

2010 PDA/FDA Vaccine Conference Course Series

Fri, 12 Feb 2010 16:41:55 GMT

Immediately following the 2010 PDA/FDA Vaccine Conference, the Training and Research Institute will be holding three half-day courses from May 19-20, 2010. The courses will be held at the Training and Research Institute in Bethesda, MD.

2010 New Brunswick Course Series

Fri, 12 Feb 2010 15:00:18 GMT

The PDA Training & Research Institute is brining 6 in-depth courses to New Brunswick, NJ, at the Heldrich Hotel from November 16 - 18, 2010.

Elements of Risk Management

Fri, 12 Feb 2010 14:03:01 GMT

June 3 - 4, 2010 This class covers the elements of an integrated risk management system, including policy level requirements for risk evaluation, mitigation, and reporting for product design as well as manufacturing and quality processes.

2010 Universe of Pre-Filled Syringes and Injection Devices - TRI Course Series

Fri, 12 Feb 2010 10:19:30 GMT

Expand your knowledge of Pre-Filled Syringes and Injection Devices by attending full-day courses offered by PDA's Training and Research Institute. Two courses wil be offered following PDA's Universe of Pre-Filled Syringes and Injection Devices Conference. Courses will be held October 20 - 21, 2010 at the same location as the conference, JW Marriott Las Vegas Resort & Spa, in Las Vegas, NV.

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 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

NEW DATES! December 14-16, 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 19-20, 2010
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 21-22, 2010
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

August 30 - September 1, 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.

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

October 26-29, 2010
This course is intended to give you a complete understanding of what is involved in developing a complete contamination control program.

Application of Disposables in Biopharmaceutics

Tue, 04 Nov 2008 15:27:51 GMT

August 26-27, 2010

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

August 24-26, 2010

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

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.

Denver Course Series

Wed, 28 Apr 2010 14:08:06 GMT

The PDA Training and Research Institute and PDA's Mountain States Chapter is pleased to bring you three training courses by popular vote and by responding directly to our members' training needs.

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

Virtual Volunteer Orientation

Thu, 29 Jul 2010 14:51:25 GMT

N/A

Cost-Effective Industry-Academia Partnering to Promote Manufacturing Excellence: A Case Study

Mon, 19 Jul 2010 12:05:03 GMT

August 17, 2010
During this web seminar, we will be exploring the following:
This web seminar will present a case study of the varied and innovative ways that Stevens Institute of Technology, a US News and World Report top-100 university, is partnering with the pharmaceutical industry to provide valuable and practical employee development options - worldwide!

PDA's Paradigm Change in Manufacturing Operations (PCMO)

Mon, 24 May 2010 14:00:25 GMT

This web seminar will explain the purpose, goals and content of the Paradigm Change in Manufacturing Operations. This webinar will provide you with an opportunity to become familiar with the infrastructure of this initiative. The primary goal of the PCMO is to utilize the PDA's membership expertise to promote the establishment of "best practices" for upcoming documents, training events, and to aid the pharmaceutical manufacturers (IMP and commercial products) to implement ICH Q8, Q9 and Q10.

PDA's Paradigm Change in Manufacturing Operations SM (PCMO) Webinar

Tue, 18 May 2010 10:08:21 GMT

N/A

Risk Management: A Way of Thinking and Its Practical Applications

Tue, 20 Apr 2010 09:19:57 GMT

August 26, 2010
In this web seminar there will be presented examples from selected processes such as, product development, validation, annual product review, change control, failures and deviations, auditing and inspections, training, documentation etc. Also, the obstacles to get risk management into the way people think and act will be discussed.

Biopharmaceutical Manufacturing: New Membrane Combinations and their Comparative Performance with Classical Membranes

Tue, 20 Apr 2010 09:03:47 GMT

November 11, 2010
The attendees will receive a good overview of various sterile filtration steps used in Biopharm. manufacturing along with the range of throughputs observed across different membrane polymers & combinations at these process steps. Exposure will also be provided to new membrane combinations & filter constructions available from several filter manufacturers.

Heavy Metals Testing: An Analytical Review of the Current Status and the Impact on the Manufacture of Drug Products

Thu, 25 Mar 2010 10:15:35 GMT

October 05, 2010
This seminar will review heavy metals testing from a historical perspective and discuss the proposed changes and limits, analytical method and instrumentation requirements and limitations and the potential impact on manufacturing.

Determination of Trace Levels of Silicone in Pre-filled Syringes and Container Closure Systems

Thu, 25 Mar 2010 10:08:21 GMT

December 16, 2010
This seminar will examine several different aqueous and organic extraction strategies for the determination of trace levels of silicone

Current Perspectives in Biofilms Growth

Wed, 24 Mar 2010 12:01:42 GMT

September 14, 2010
This presentation will discuss how biofilms form, how they affect industrial and medical systems, why they are resistant to treatment, and methods we use to study and eradicate them.

How To Use Part 11 To Add Value To Your Work (For More Than Gap Analysis And Remediation)

Thu, 18 Mar 2010 16:40:10 GMT

November 9, 2010
This seminar will allow the attendees to accomplish three tasks: create requirement specifications for new automated systems to comply with existing regulations, quickly assess existing automated systems for compliance, and remediate (existing automated systems) for gaps in compliance.

Review by Exception- Implementing MES and Maintaining Compliance

Thu, 18 Mar 2010 16:26:15 GMT

November 4, 2010
This web seminar will present on how to implement MES and maintain compliance

State of Art Design of Vaccine Facilities

Thu, 18 Mar 2010 16:06:31 GMT

October 7, 2010
This web seminar will present you with background information about what to take into account in today's design of vaccine facilities, whether they are single- or multi product facilities, including the necessary focus on containment. The seminar will include cases.

Myths And Realities In Validating Pharmaceutical, Biotechnology, and Medical Device Facilities

Thu, 18 Mar 2010 15:36:19 GMT

September 28, 2010
The presenter discusses myths and realities experienced over 20+ years of validating facilities for pharmaceutical, biotechnology, and medical device firms. Five key concepts are then presented which are essential to completing the commissioning and validation of these facilities right, first time, and on-budget.

Security by Design, Modernizing Controlled Substance Tracking

Thu, 18 Mar 2010 15:26:40 GMT

September 22, 2010
This web seminar presentation will discuss the challenges of controlled substance management, the solutions developed to meet the needs, and the benefits that this company was able to obtain from implementing paperless processes in LabWare.

Batch Definition and Logistic Systems for the Supply of Primary Packaging Materials made of Tubular Glass

Thu, 18 Mar 2010 15:13:12 GMT

September 2, 2010
This presentation offers valuable information about the topics of logistics and batch release for the supply of primary packaging materials. The audience will receive important information about the logistic challenges arising as well as the relevant options for a solution offered by capable suppliers.

Scale-up of filters for sterilizing filtration of liquids

Thu, 18 Mar 2010 14:59:53 GMT

August 19, 2010
This talk will highlight key principles for reliable scale up of microfiltration devices and present new advances in scaling methodologies for sterilizing filtration of liquids.

Energy Efficient Temperature, Humidity, and Microbial Control for Pharmaceutical Manufacturing with Liquid Desiccant Dehumidification

Thu, 18 Mar 2010 14:02:21 GMT

December 1, 2010
This web seminar will explore the pharmaceutical manufacturing processes and demand on precise conditions and clean air.

Application of a Risk-Based Approach to Optimize a Rapid Mycoplasma Test

Thu, 18 Mar 2010 13:42:30 GMT

July 15, 2010
This web seminar will explore 21 commercially available mycoplasma tests and ranking of critical risk attributes resulted in the selection of 4 methods for further evaluation. As well as explore how a formal risk assessment process using Failure Mode Effects Analysis (FMEA) identified areas of uncertainty in routine lot release testing. The evaluation of risk to the safety of cell therapy and tissue-engineered products should rely upon scientific knowledge and ultimately link to the protection of the patient.

The Employment of PAT-based Manufacturing Science to Solve Capacity Constraints and to Increase Production Efficiency

Thu, 18 Mar 2010 11:47:52 GMT

September 30, 2010
This web seminar will address the utilization of a PAT-based in-line buffer preparation system that prepares on-demand tens of thousands of liters of dilute buffers in a footprint of less than 35 ft². The elimination of buffer variability as well as the need for large tanks of dilute buffers, combined with "point of use" control of final buffer make-up, not permitted by mass flow controlled blending, alleviates both downstream capacity constraints and process inefficiencies, resulting in simple, lower cost operations with highest product quality as a result of QbD.

Use of Nanotechnology Instrumentation for Particle Size, Shape and Morphology in Drug Development

Thu, 18 Mar 2010 11:15:35 GMT

September 1, 2010
This web seminar will highlight the use of electron microscopy for the analysis of nanomaterials within the pharmaceutical industry. Specific sample characteristics will be discussed as well as the associated challenges in this type of analysis. Several example systems currently being used will be presented to demonstrate utility.

Coupling USP Methods and Automated Characterization Techniques to Facilitate a Quality by Design Approach

Wed, 17 Feb 2010 10:48:46 GMT

November 3, 2010
This web seminar will follow a scenario in which an industry standard is coupled with automated characterization techniques for foreign particulate matter analysis. The scenario will track the implementation of this process for quality assurance from pre-to post-production samples.

High Efficiency Single Use Mixing Systems for Biopharmaceutical Applications

Wed, 17 Feb 2010 10:19:47 GMT

April 29, 2010
This Web seminar will focus on the characterization of a single-use mixing solution, based on a levitated impeller and square tank geometry. Case studies for liquid -liquid blending and liquid-solid mixing will be discussed.

Virus Clearance

Thu, 04 Feb 2010 16:39:42 GMT

September 9, 2010
This web seminar covers basic theory and practical applications for the removal / inactivation of virus contamination in biopharmaceuticals and biological materials.

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

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.

Pharmaceutical Water Mythology

Tue, 26 Jan 2010 12:50:10 GMT

February 23, 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

November 10, 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.

Automated Validation Lifecycle Management - A Working Model

Fri, 28 Aug 2009 16:54:15 GMT

September 23, 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

N/A

Registration Form - Excipients

Mon, 08 Dec 2008 15:31:58 GMT

N/A

Registration Form - Supply Chain Conference

Mon, 01 Dec 2008 10:00:46 GMT

N/A

Registration Form - December 2008 Web Seminars

Wed, 26 Nov 2008 11:34:33 GMT

N/A

FAQs

Mon, 11 Aug 2008 15:54:28 GMT

FAQs Online Learning

Online Learning Presentation Guidelines

Thu, 10 Jul 2008 13:32:57 GMT

N/A

System Requirements

Tue, 16 Sep 2008 12:49:24 GMT

N/A

Excipients: What You Need to Know from GMPs, GDPs and Beyond

Mon, 29 Sep 2008 12:27:10 GMT

N/A

Microbial Failure Investigations - A Systematic Approach

Mon, 08 Sep 2008 16:10:44 GMT

N/A

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

N/A

Registration Fees

Tue, 14 Oct 2008 16:15:33 GMT

N/A

Directions

Mon, 11 Aug 2008 15:52:07 GMT

N/A

PDA_TR1_web_banner

Fri, 03 Oct 2008 10:57:44 GMT

N/A

Agenda

Fri, 26 Sep 2008 14:09:54 GMT

N/A

List of Area Hotels

Thu, 10 Jul 2008 13:27:34 GMT

N/A

Registration Form

Fri, 26 Sep 2008 14:01:46 GMT

N/A

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

N/A

devprefilled2008nov

Thu, 18 Sep 2008 17:06:46 GMT

N/A

DVCD - Course Brochure

Thu, 10 Jul 2008 13:15:14 GMT

N/A

Training Workshop on PDA Technical Report No.1, Revised 2007

Mon, 15 Sep 2008 12:06:04 GMT

N/A

Jianguo Garden Hotel

Thu, 18 Sep 2008 14:41:03 GMT

N/A

Agenda

Mon, 08 Sep 2008 16:07:18 GMT

N/A

Training Workshop on PDA Technical Report No. 26, Revised 2008

Mon, 15 Sep 2008 11:51:13 GMT

N/A

Jianguo Garden Hotel

Thu, 18 Sep 2008 14:41:03 GMT

N/A

Agenda

Mon, 08 Sep 2008 16:07:33 GMT

N/A

Training Workshop on PDA Technical Report No. 26, Revised 2008

Mon, 08 Sep 2008 16:07:26 GMT

N/A

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

N/A

Hyatt Cambridge

Wed, 24 Sep 2008 18:33:43 GMT

N/A

Agenda

Mon, 08 Sep 2008 15:29:42 GMT

N/A

Registration Fees

Mon, 08 Sep 2008 15:29:48 GMT

N/A

Networking Opportunities

Mon, 08 Sep 2008 15:29:54 GMT

N/A

Exhibitors and Sponsorships

Thu, 18 Sep 2008 22:19:42 GMT

N/A

Program Committee

Mon, 08 Sep 2008 15:30:06 GMT

N/A

Venue

Mon, 08 Sep 2008 15:30:19 GMT

N/A

Continuing Education Credits

Mon, 08 Sep 2008 15:30:25 GMT

N/A

Brochure

Thu, 18 Sep 2008 16:49:50 GMT

N/A

Banner

Thu, 18 Sep 2008 21:56:57 GMT

N/A

Hyaluron Contract Manufacturing Tour/Open House

Mon, 08 Sep 2008 16:04:21 GMT

N/A

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

N/A

Networking Opportunities

Mon, 08 Sep 2008 15:32:10 GMT

N/A

Exhibition and Sponsorship

Tue, 16 Sep 2008 11:50:45 GMT

N/A

Program Committee

Mon, 08 Sep 2008 15:32:23 GMT

N/A

PDA TRI Training Courses

Mon, 08 Sep 2008 15:32:29 GMT

N/A

Venue

Mon, 08 Sep 2008 15:32:35 GMT

N/A

Continuing Education Credit

Mon, 08 Sep 2008 15:32:41 GMT

N/A

Brochure

Thu, 10 Jul 2008 12:48:50 GMT

N/A

Agenda

Thu, 10 Jul 2008 12:48:46 GMT

N/A

Banner Image

Wed, 17 Sep 2008 08:54:47 GMT

N/A

More Training Course Info

Wed, 17 Sep 2008 09:25:16 GMT

N/A

On-Demand Web Seminar

Fri, 05 Sep 2008 12:09:02 GMT

N/A

Process Validation of Protein Manufacturing - PDA Technical Report No. 42

Mon, 11 Aug 2008 16:38:16 GMT

N/A

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

N/A

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

N/A

Registration Form

Thu, 18 Sep 2008 16:58:32 GMT

N/A

Brochure

Fri, 26 Sep 2008 15:40:18 GMT

N/A

Hard Rock San Diego

Thu, 18 Sep 2008 08:35:31 GMT

N/A

Hyatt San Diego

Thu, 18 Sep 2008 08:31:06 GMT

N/A

Registration Fees

Wed, 03 Sep 2008 17:27:22 GMT

N/A

Networking Opportunities

Wed, 03 Sep 2008 17:29:34 GMT

N/A

Exhibition and Sponsorship

Wed, 17 Sep 2008 13:09:50 GMT

N/A

Program Committee

Fri, 12 Sep 2008 11:50:38 GMT

N/A

bd_sponsor

Thu, 10 Jul 2008 09:26:04 GMT

N/A

Gary Hall Jr. Press Release

Wed, 17 Sep 2008 14:53:01 GMT

N/A

gary_hall_full

Thu, 10 Jul 2008 09:26:57 GMT

N/A

Agenda

Wed, 03 Sep 2008 17:05:22 GMT

N/A

Gary Hall photo

Wed, 03 Sep 2008 16:58:39 GMT

N/A

pre-filled banner

Wed, 03 Sep 2008 16:54:45 GMT

N/A

Venue

Thu, 18 Sep 2008 08:26:26 GMT

N/A

Continuing Education Credit

Wed, 17 Sep 2008 15:17:58 GMT

N/A

About Gary Hall Jr.

Thu, 10 Jul 2008 09:29:43 GMT

N/A

2009 PDA Annual Meeting

Mon, 11 Aug 2008 15:30:40 GMT

N/A

Exhibitor logos

Mon, 13 Apr 2009 10:38:09 GMT

N/A

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

N/A

Workshop on FDA's New Guidance on Process Validation

Thu, 18 Dec 2008 10:59:11 GMT

N/A

Brochure

Wed, 08 Oct 2008 15:14:17 GMT

N/A

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

N/A

Networking Events Registration Form

Wed, 04 Feb 2009 16:11:03 GMT

N/A

Message from the Program Chair

Thu, 06 Nov 2008 14:11:56 GMT

N/A

Agenda

Wed, 05 Nov 2008 12:31:40 GMT

N/A

Keynote Speakers

Mon, 06 Oct 2008 15:38:54 GMT

N/A

FDA-Speakers

Mon, 06 Oct 2008 15:07:18 GMT

N/A

Registration Fees

Mon, 11 Aug 2008 17:37:26 GMT

N/A

2009 PDA Annual Meeting: Exhibition and Sponsorships

Fri, 19 Sep 2008 13:58:00 GMT

N/A

Networking Opportunities

Wed, 18 Mar 2009 08:14:34 GMT

N/A

PDA's 5th Annual Career Fair

Tue, 21 Oct 2008 10:21:37 GMT

N/A

Program Committee

Mon, 11 Aug 2008 17:37:42 GMT

N/A

Venue

Mon, 11 Aug 2008 17:37:53 GMT

N/A

Continuing Education Credit

Mon, 11 Aug 2008 17:37:58 GMT

N/A

Red Rock Hotel

Sun, 21 Sep 2008 12:25:06 GMT

N/A

2009 Banner

Fri, 05 Sep 2008 12:38:05 GMT

N/A

2008 PDA Conference on Quality by Design

Mon, 11 Aug 2008 15:30:11 GMT

N/A

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

N/A

08-pda-qbd-agenda

Thu, 18 Sep 2008 16:58:01 GMT

N/A

Message From the Chair

Thu, 10 Jul 2008 12:54:05 GMT

N/A

Brochure

Thu, 10 Jul 2008 12:54:01 GMT

N/A

Registration Fees

Mon, 11 Aug 2008 17:33:39 GMT

N/A

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

N/A

Venue

Mon, 11 Aug 2008 17:34:07 GMT

N/A

Continuing Education Credits

Mon, 11 Aug 2008 17:34:12 GMT

N/A

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

N/A

Message from the Program Chairs

Tue, 26 May 2009 15:42:48 GMT

N/A

Brochure

Wed, 04 Feb 2009 11:39:03 GMT

N/A

Exhibition and Sponsorships

Tue, 27 Jan 2009 11:24:31 GMT

N/A

Agenda

Mon, 26 Jan 2009 10:48:37 GMT

N/A

Registration Fees

Tue, 06 Jan 2009 11:54:44 GMT

N/A

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

N/A

Registration Form

Tue, 13 Jan 2009 12:59:05 GMT

N/A

Venue

Mon, 29 Dec 2008 15:29:19 GMT

N/A

Workshop on FDA's New Guidance on Process Validation

Mon, 29 Dec 2008 13:40:01 GMT

N/A

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

N/A

Program Planning Committee

Tue, 20 Oct 2009 10:31:28 GMT

N/A

Continuing Education Credit

Tue, 20 Oct 2009 10:29:57 GMT

N/A

Agenda

Mon, 26 Jan 2009 11:59:59 GMT

N/A

Selection and Implementation of Advanced Aseptic Processing Techniques

Wed, 14 Jan 2009 13:39:05 GMT

N/A

Registration Form

Tue, 13 Jan 2009 12:55:17 GMT

N/A

Venue

Thu, 08 Jan 2009 15:35:23 GMT

N/A

Registration Fees

Tue, 06 Jan 2009 11:37:15 GMT

N/A

Sterilization Technology Today and Tomorrow

Mon, 29 Dec 2008 12:07:56 GMT

N/A

Exhibition and Sponsorships

Wed, 24 Dec 2008 11:25:09 GMT

N/A