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Developing Contamination Control Strategy

Wed, Jul 19, 2023 1:00 PM EDT{LOCAL_TZ}

Event Overview

Learn more about contamination control strategy (CCS), how to identify and assess risk, prepare mitigation pathways, and define preventive actions associated with contamination in sterile product manufacturing.

Key Learning Objectives
  • Learn about elements for developing a containment control strategy.
  • Know what to expect from the technical report.
  • Understand practical considerations for containment control strategy.
Who Should Attend
  • Packaging designers, engineers, QA/QC, design engineers, regulatory affairs, clinical, clinical research, compliance, drug safety, procurement, project management, R&D, regulatory affairs, supply chain, validation


Featured Speakers

Susan Schniepp
Susan Schniepp
Distinguished Fellow - Regulatory Compliance Associates®
Chair of Board of Directors - Parenteral Drug Association® (PDA)

Susan Schniepp is the knowledge leader for Regulatory Compliance Associates® and is Chair of the Parenteral Drug Association (PDA) Board of Directors. Her background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record review.

Speaker’s Email: s.schniepp@rcainc.com

Martell Winters, B.S.
Martell Winters, B.S.
RM/SM (NRCM)
CISS-RAD

Martell Winters is a Director of Science at Nelson Labs and a recognized authority and industry leader on radiation sterilization, bioburden, industrial microbiology, aseptic processing, environmental control, and tissue processing. He has over 25 years of experience on these topics and has worked with clients in all areas of the world speaking, training, and consulting in the medical device, tissue, and pharmaceutical industries. Martell is an active committee member of many working groups within AAMI.

For any technical questions please contact Jorge de la Bandera: JdelaBandera@mjhlifesciences.com