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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Contamination Control For Pharmaceutical Products: Real-World Moist-Heat-Validation Pitfalls And Proper Verification of Sterility

Published Date: July 27, 2022

Moist-heat sterilization is a commonly used and widely accepted process in pharmaceutical processes. As such it is critical that it be carried out correctly. In this webinar we will address real-world observations relating to moist-heat-sterilization processes, discuss the science behind the observations, and present solutions to result in a successful validation outcome.

As a contamination-control program is meant to result in microbiologically acceptable product, usually with a sterile claim, it is also critical to be capable of demonstrating sterility. Although demonstration or verification of sterility is commonly accomplished by performance of a test for sterility via USP<71>, that test only represents one slide in the complete movie of contamination control, thus a fuller perspective of verification of sterility must be considered and will be addressed.

Learn more about the presenters below.

Martell Winters

Martell Winters

BS, RM/SM (NRCM), CISS-RAD
Scientific Competency Expert

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.

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Susan Schniepp

RCA Distinguished Fellow, Regulatory Compliance Associates

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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Steve Lynn

Executive VP, Pharmaceuticals, Regulatory Compliance Associates

Steve has over 20 years of quality- and regulatory-compliance experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in compliance matters related to Current Good Manufacturing Practices (CGMP) and has significant experience with other GxP quality- and regulatory-compliance issues.

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Jason Pope

Senior Scientist

Jason Pope is a certified quality auditor and specializes in providing consultations for clients about sterilization of reusable medical devices, endoscopes, and pharmaceuticals and general sterilization validation process development. He has over 19 years of experience working in research and development, validation, and routine control of various sterilization processing modalities including, but not limited to, steam, ethylene oxide (EO), dry heat, and H2O2 gas plasma sterilization. His experience includes commissioning of sterilization vessels for clients including IQ/OQ/PQ performance. As a member of the American Association of Medical Instrumentation (AAMI), he plays an active role, in concert with the FDA and regulatory committees, in developing standards and voting on changes to those standards.

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