|
Pharmaceutical and Biopharmaceutical Microbiology 101 |
Join David Matsuhiro, Cleanroom Compliance, Inc., June 9-13, as he leads you through a comprehensive course comprised of microbiological sampling, testing and identification techniques. Pharmaceutical and Biopharmaceutical Microbiology 101 is a laboratory course that details the principles behind microbiological practices to better understand, troubleshoot and solve many issues related to environmental and personnel monitoring, water systems, cleaning and disinfection, and other microbiological testing performed in your QC-Microbiology Laboratory. Seating list limited.
 Learn more
Register |
|
|
 |
2008 PDA Virus & TSE Safety Forum
June 3-5 | Berlin, Germany
Conference | Exhibition | Workshop
The forum will create a platform for discussion about critical issues and new technologies in virus and TSE safety. Special focus will be given to study design for filtration steps, quality of virus spike preparations and the use of in-house data to shorten efforts to demonstrate virus safety of biopharmaceuticals. Presentations also will focus on the infectivity of tissue, TSE spike preparations, TSE sanitization and new development in screening tests for detection of TSE in blood.
Learn
More
Register
|
2008 PDA Technical Reports: A Fresh Look
June 12, 2008 | San Francisco, California
Join colleagues for discussions on implementation of several important PDA guidance documents. Highlights from the meeting agenda are below:
PDA Technical Report No. 45, Filtration of Liquids using Cellulose-Based Depth Filters
George Quigley, President, Ertel Alsop
For the first time, TR-45 provides guidelines for the selection, validation and use of cellulose-based depth filters in pharmaceutical and bio-pharmaceutical applications that is useful in all regulatory environments. This report also provides information on physical and performance characteristics of cellulose-based depth filter products in sheet, lenticular cartridge (modules) and capsule configurations.
PDA Technical Report No. 26, Revised 2008, Sterilizing Filtration of Liquids
Jean Bender, Senior Engineer, Genentech, Inc., will discuss the 2008 revisions which provide recommendations on correlating integrity test results to bacterial retention as well as setting integrity test limits for product-wetted filters. This revision also includes new sections on single use disposable systems, process risk assessments and a glossary as well as an expanded section on filter integrity testing. Updated charts on validation requirements and illustrations complete this revision.
Learn
more
Register
|
Seminar on PDA Technical Report No. 1, Revised 2007, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control
June 26-27 | Montreal, Canada
Michael Sadowski, Manager, Sterile Product and Process Development, Baxter Healthcare Corporation will lead a discussion of Section 3 – Sterilization Science of TR-1, which covers the role of microbiology in the development of moist heat sterilization processes. Keith Shuttleworth, Senior Consultant, Shuttleworth and Associates, will finish the presentation on sterilization science with a discussion of Thermal Science and Steam Quality. A panel discussion on these and other topics will allow attendees to ask questions of the presenters and discuss challenges that your company faces.
Download agenda
Learn
more
Register
|
2008 PDA/FDA Joint Regulatory Conference
Harmonization, Implementation and Modernization: Achieving a Future Vision
September 8-12, 2008 | Washington, D.C.
Conference | Exhibition | Courses
During Plenary Session 3, FDA representatives will provide an Agency point of view on:- Impact of current Quality System activities
- How Quality System thinking is changing the way FDA does business
- What regulatory issues have accompanied the further enhancement of Quality Systems
- Efforts by FDA to develop formal Quality Systems
- Impact of ICH Q10 and FDA’s Quality Systems guidance on Agency activities
- Status and impact of proposed changes to the drug product GMPs
FDA’s Martine Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance, CVM has been confirmed as a participant. FDA representatives from ORA and the offices of compliance for CBER, CDER and CDRH have been invited to speak.
Learn
more
Register
|
2008 Discussion Forum on: Revision of EU GMP Annex 1 – Issues and Challenges
September 29 | Milano, Italy
Workshop | Exhibition
GMP Annex 1 for Sterile Medicines - What Does it Mean to You?
Join Inspectors like Paul Hargreaves (MHRA, UK) and colleagues in Milan, 30 September, to learn about the recently published EU GMP Annex 1, Manufacture of Sterile Medicinal Products. If you are involved with aseptic or terminally sterilized medicinal products, anywhere in the world, you will be affected by this GMP Annex. Discussion topics include clean room classification, environmental monitoring, media fills, bioburden, vial capping and more. Click here for a copy of Annex 1.
The forum will be lead by Paul Hargreaves, MHRA Senior Inspector, and leader of the Inspector Working Group that drafted the revised Annex 1.
Learn
more
Register
|
The Universe of Pre-filled Syringes and Injection Devices
October 6-7 | San Diego, California
Conference | Exhibition
A two-part plenary session will examine case studies on manufacturing, new facilities, technology transfer and extractables/leachables. During the eight concurrent sessions, industry speakers will cover topics such as:
- End-user and marketing benefits
- Supplier and quality issues
- New injection devices
- Regulatory strategies
- Development
- Safety
- Machine technology
- Risk Assessment and Management
This year’s forum will be packed with informative sessions and speakers, and will include ample time for discussions and networking. In addition, exhibitors will be on hand to display commercially-available technology and services.
Learn
more
Register
|
PDA Development and Regulation of Clinical Trial Supplies Conference
November 10-11 | Boston, Massachusetts
Conference | Exhibition
Come together with international regulatory and industry representatives at the PDA Development and Regulation of Clinical Trial Supplies Conference to learn about the challenges and opportunities facing organizations involved in the manufacture, packaging, release and shipment of materials to clinical trial sites. Industry leaders will share expertise on topics ranging from proof of concept to marketing authorization, and discuss lessons learned from actual case studies.
Learn
more
Register
|
 |
Raleigh Training Course Series
June 2-4, 2008 | Raleigh, North Carolina
Next week, PDA training comes to Raleigh, North Carolina! Seven courses are being offered: Achieving cGMP Compliance During the Development of a Biotechnology Product; Practical and Effective Application of Design Review as a Risk Management Tool; Pharmaceutical Water System Design and Validation; Preparing for an FDA Pre-Approval Inspection (PAI); Media Fills for Aseptic Processing; and Biosystems Fundamentals: Bioreactors, Fermentation and Cell Culture - Theory & Practice.
Learn more
Register
|
Developing a Moist Heat Sterilization Program within FDA Requirements
June 4-6, 2008 | Bethesda, Maryland
The PDA Training and Research Institute facility will host a hands-on laboratory class beginning on June 4. Developing a Moist Heat Sterilization Program within FDA Requirements gives you the necessary methods and data requirements for cycle development, product sterilization of solutions, container/closures and device type combination products.
Learn more
Register
|
 |
Metro Chapter
PDA wants to welcome the new chapter leaders for the Metro Chapter. On May 14, 2008, the Metro chapter held elections for the 2008-2010 term. The new officers are: -
Lara Soltis, President
- Robert Johnson, President-Elect
- Robert Seltzer, Secretary
- Lisa Smith, Treasurer
Congratulations to the new Metro Chapter Officers!
Learn more
|
West Coast Chapter
June 12, 2008│ Burlingame, California
This meeting, which will be held in conjunction with and immediately following the 2008 PDA Technical Reports: A Fresh Look meeting on June 12, will feature Harold Baseman, Chief Operations Officer, Valsource, LLP, who will give a presentation on PDA Technical Report No. 44, Quality Risk Management for Aseptic Processes.
Learn more
Register
|
Delaware Valley Chapter
June 17, 2008│ Malvern, Pennsylvania
Are you interested in the "new and improved" worldwide standards and requirements for product labeling? Guest speaker Barbara Fenelli will lead a discussion on the development of worldwide product labeling and how labeling development parallels the drug development process. She will describe how good labels include the required information about the safe and effective use of the product and can include some of the other uses, too.
Learn more
Register
|
United Kingdom Chapter
June 12, 2008│Epsom, United Kingdom
All members are welcome to attend the June 12, 2008, PDA United Kingdom Chapter Board Meeting.
Learn more
|
 |
| New Job Opportunities PDA’s Career Center can help you connect with leading companies looking to hire qualified individuals like you. New career opportunities are being posted every day at our Career Center. Check out these new openings:
Learn
more
|
|
|
| 
CONFERENCES
2008 PDA Virus & TSE Safety Forum
Berlin, Germany
June 3-5, 2008
2008 Technical Reports - A Fresh Look
San Francisco, California
June 12, 2008
2008 PDA/EBE on Biopharmaceutical Development and Manufacturing
Dublin, Ireland
June 24-25, 2008
Seminar on PDA Technical Report No. 1, Revised 2007, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control
Montreal, Canada
June 26-27, 2008
2008 PDA/FDA Joint Regulatory Conference
Washington, D.C.
September 8-12, 2008
2008 Pharmaceutical Freeze Drying Technology
Brussels, Belgium
September 23-24, 2008
The Universe of Pre-filled Syringes and Injection Devices
San Diego, California
October 6-7, 2008
More
Conferences
|
TRAINING
COURSES
Environmental Monitoring Database and Trending Technologies
Bethesda, Maryland
June 11-13, 2008
Rapid Microbiological Methods
Bethesda, Maryland
August 4-8, 2008
Computer Product Supplier Auditing Process Model: Auditor Training
Bethesda, Maryland
August 14-15, 2008
More
Courses |
| WEB
SEMINARS
Steam Sterilization Validation to Meet European Requirements
Online
June 5, 2008
On-Demand
Web Seminars
More
Web Seminars |
| CHAPTERS
Mountain States Chapter
Golf Tournament
June 6, 2008
United Kingdom Chapter
Board Meeting
June 12, 2008
Southeast Chapter
Eighth Annual PDA Southeast Chapter Golf Social
June 13, 2008
Capital Area Chapter
Detection of Microbial Contamination by Rapid RT-PCR
June 25, 2008
Chapter
Events |
| BOOKSTORE
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I and II
Edited by Richard Prince, PhD
Radiation Sterilization: Validation and Routine Operations Handbook
By Anne F. Booth |
|
Help
shape the PDA Connector by sending us your ideas
on how to improve the way you receive the latest PDA news.
Your feedback will help the PDA Connector better
suit your needs and those of your colleagues.
Please contact
Faramarz Kolivand, Webmaster: kolivand@pda.org.
|
|
|
Help us improve the PDA website by completing this 
