+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Raw Materials in Pharma/Biotech Production - Webinar (Recorded)

  • Webinar

  • 90 Minutes
  • June 2019
  • Compliance Online
  • ID: 4899971
Why Should You Attend:

This presentation is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing. By the end of this program, you will understand the requirements for raw material selection, receipt, testing, storage, and use. Guidance and skills for practical implementation of regulatory requirements will be presented.

The program will address approaches to selecting primary and secondary suppliers of raw materials, developing an incoming receipt and testing process, adequate and appropriate storage, and other considerations for the raw materials used in drug product processing. The information obtained will also enable completion of the raw material information in Module 3 of a CTD application.

Areas Covered in the Webinar:

Selecting raw material suppliers
Receipt, Testing and Storage of starting materials
Control strategy
Submission of information
Life cycle management

Speakers

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).