Nelson Laboratories

This webcast reviews contamination control strategy, how to identify and assess risk, prepare mitigation pathways, and define preventive actions associated with contamination in sterile product manufacturing.

https://www.pharmtech.com/pt_w/contamination-control

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.

Learn about elements for developing a containment control strategy.

Know what to expect from the technical report.

Understand practical considerations for containment control strategy.

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


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.




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.

Webcasts

Webinar Date/Time: Wed, Jul 19, 2023 1:00 PM EDT

Developing Contamination Control Strategy

Articles

Importance of compatibility studies for drug-device products
How to test for in-use stability, chemical compatibility, and biocompatibility

When Drug Meets Device: How to Assess Compatibility

This paper describes the existing regulatory framework for combined products and focuses on stability testing to assess drug or biological-device compatibility.