Webinar

Contamination Control Strategy

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

Key Learn 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.

 

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    Presenters

    Susan Schniepp

    Susan Schniepp

    RCA Distinguished Fellow

    With more than 40 years of industry experience in quality control and quality assurance, Sue has had responsibilities for complaints, labeling, investigations, compendial affairs, and other quality systems. In addition to RCA, she has held leadership roles at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott; and Hospira.

    She has served the Parenteral Drug Association (PDA) as a member of the Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of PDA's Regulatory Affairs / Quality Advisory Board. She was also awarded PDA's Distinguished Service Award in 2008.

    Martell Winters

    Scientific Competency Expert

    BS, RM/SM (NRCM), CISS-RAD

    Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.