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Upcoming Global Events
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01/14/2009
:
Detecting Microbial Contamination Using Rapid Microbiological Methods
, Bethesda, Maryland
01/28/2009
:
Global Challenges for Investigational Medicinal Products
, Rome, Italy
02/03/2009
:
2009 PDA Conference on Rapid Microbiology Methods: Successful Implementation Strategies
, Berlin, Germany
02/09/2009
:
San Diego Course Series
, San Diego, California
03/23/2009
:
2009 PDA Pharmaceutical Cold Chain Management Conference
, Bethesda, Maryland
04/20/2009
:
2009 PDA Annual Meeting
, Las Vegas, Nevada
What's New!
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Recommended Reading
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PDA Visual Inspection Forum Call for Papers Deadline – April 1, 2009
Visual inspection is a vital element of the manufacturing process and affects the quality assurance of injectable products. PDA is currently seeking scientific abstracts for presentations at the 2009 PDA Visual Inspection Forum, October 19-23, 2009, Bethesda, Maryland.
Workshop: Cleanroom Technology and Contamination Control
Preceding the 2009 PDA Annual Meeting, this workshop will examine how to reach compliance with both US and European Union (EU) requirements in the areas of Cleanroom Technology and Contamination Control. Topics of discussion will cover conventional Aseptic Processing, Isolator Technology, RABS and Blow-Fill-Seal (BFS) technology.
Registration Now Open! Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems
Training from Rafik Bishara, PhD, on the concepts and practices of cold chain development and packaging distribution systems. March 25-26, 2009 at PDA TRI in Bethesda, Maryland.
Call for volunteers
The Combination Products Task Force and related sub-committees need additional PDA members with experience in combination products to help identify membership needs and determine PDA’s future role in combination products.
Expert, Bio-Pharmaceutical Training in San Diego, February 9-11
Expand your knowledge and learn new skills from the experts at the PDA TRI San Diego Course Series. As a participant, you will come away with the critical knowledge and expertise necessary to propel your career. Register by December 30, 2008, and save $100 on a one-day course or $200 on a two- or three-day course.
Agenda Now Available for 2009 PDA Annual Meeting
The conference program will feature technical presentations organized by five tracks: Manufacturing Process Science, Data Management, Quality Science, Process Development and Validation.
Registration Open for GMP 101 Course with Gregory Meyer, Compliance Media
This course is designed for new and experienced QA and regulatory professionals who need or want to be more familiar with manufacturing process steps and the GMP requirements for all parts of manufacturing.
Space is limited so sign up today!
Rosa J. Motta confirmed as 2009 Cold Chain Conference speaker
PDA is pleased to announce that FDA’s Rosa J. Motta, Senior Compliance Officer, CDER will speak on Points to Consider in Protecting Drugs from the Effects of Exposure to Temperature Variations During Transportation and Storage during the 2009 PDA Pharmaceutical Cold Chain Management Conference.
Call for Strategic Minds
PDA’s Strategic Planning Committee would like to ask for volunteers to work in specific topic task forces to analyze future requirements and formulate activity needs. Please contact Maik Jornitz, Strategic Planning Committee Chair, at
maik.jornitz@sartorius-stedim.com
to learn more about the different task force topics and/or to volunteer to work in one of the task forces.
Biological Indicators for Sterilization Processes
Editors: Margarita Gomez, PhD and Jeanne Moldenhauer
Risk-Based Compliance Handbook
Author: Siegfried Schmitt, PhD
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