Developing Your Roadmap to Annex 1 Compliance

The 2022 revision to Annex 1 introduced the industry to the concept of a contamination control strategy (CCS) as well as reinforcing the need to utilize Quality Risk Management (QRM) principles to guide decision making.  The development of an effective and sustainable CCS should include a strong strategic plan that invokes the quality system as an enabler and risk-based decision-making to prioritize the knowledge collected.  This course will provide attendees with the tools necessary to interpret the revisions to Annex 1 and begin their journey toward compliance.

Attendees of this course will be able to:

  • Identify the changes to Annex 1 and document gaps with current contamination control program
  • Define the steps necessary to appropriately address compliance gaps
  • Select appropriate Quality Risk Management tools to prioritize and implement CAPAs
  • Develop a strategy to author and maintain an effective Contamination Control Strategy
  • Evaluate the effectiveness of the contamination control strategy over time


Amanda McFarland
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Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. McFarland is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, and an instructor for the PDA. She has a B.S. in entomology and an M.S. in mycology, both from the University of Florida.

James Wamsley
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Mr. Wamsley has been with ValSource since 2022 as a Microbiology Consultant focusing on the development, establishment and improvement of contamination control programs, environmental monitoring and trending programs and aseptic practices. James has nearly 20 years of experience in the pharmaceutical industry.  He started his career at PDA’s Training and Research institute with responsibility for management, development and delivery of laboratory training courses in Bethesda, Md. and for the in-house training programs.  Most recently he was responsible for leading the site microbial control and environmental monitoring teams for a vaccine and gene therapy manufacturing facility.  He holds a B.S. degree from the University of Maryland, Baltimore County in Biological Sciences. 

Next Date and Location

May 10, 2023
8:30 a.m. - 5 p.m. Central TIme
Intercontinental St. Paul Riverfront*
St. Paul, Minnesota
During ESTECH 2023
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*Virtual option also available.