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.
Learn more below about the presenters.
Martell Winters, Scientific Competency Expert, Nelson Labs
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.
Susan Schniepp, Distinguished Fellow, RCA
Susan has over 40 years of quality-assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award. Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011 to 2013 and from 2016 to 2019 and is currently the Chair of the board of directors. She has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing-data-integrity issues and participating in PDA’s ANSI’s standard-setting activities regarding purchasing controls and quality culture.
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