ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today proudly announced two leadership team members will lead a live, interactive training webinar hosted by Pharma Webinars, “Are You Ready for Annex 1? Points to Consider When Doing an Annex 1 Self-Assessment.”
Guided by two ValSource experts, Stephen E. Langille, Ph.D., Senior Microbiology Consultant at ValSource, and Darius Pillsbury, Senior Consultant at ValSource, this inclusive live webinar will provide attendees with an overview of the history and changes to Annex 1, cover many of the topics necessary to ensure readiness for Annex 1 compliance, and describe the impact of this document on the global regulatory environment.
The specific topics to be discussed during the webinar include:
- The development and implementation of a contamination control strategy
- Risk assessments and quality risk management for sterile products
- Control of cleanrooms and environmental monitoring
- Sterile filtration and filter validation
- Control and use of isolators and RABS for aseptic processing
- Personnel qualification and behavior in aseptic environments
- Aseptic processing simulation requirements
Scheduled for Wednesday, April 28th at 10:30 a.m. until 12:30 p.m EST, to join “Are You Ready for Annex 1? Points to Consider When Doing an Annex 1 Self-Assessment,” attendees must register in advance at https://www.pharmawebinars.com/registration-form/.
Find more details at https://www.pharmawebinars.com/eu-gmp-annex-1.
About Stephen E. Langille, Ph.D.
Steve spent 19 years as a microbiologist with the FDA serving as a senior microbiology reviewer, branch chief, and director of the Division of Microbiology assessment in the Center for Drug Evaluation and Research. He now works for ValSource Inc. as a senior microbiology consultant, specializing in the areas of microbiological control and testing of non-sterile drug products, environmental monitoring, regulatory compliance and GMPs, sterility assurance for parenteral products, visible particulate evaluation, and control, and microbiological control of pharmacy compounding operations. Steve Received his B.S. degree in biology from the University of Massachusetts and his Ph.D. in microbiology from the University of Maryland. Visit https://www.pharmawebinars.com/stephen-e-langille to learn more.
About Darius Pillsbury
Darius has over 20 years of experience in the life sciences and currently is a Senior Consultant working for ValSource. Darius currently consults on many topics related to the development, manufacturing, and quality of medicinal products with a primary focus in the Process Validation lifecycle including Control Strategy development, Process Performance Qualification, Product Comparability, Technology Transfer, and Continued Process Verification. Darius holds a Bachelor of Science in Chemical Engineering from Tufts University. Learn more at https://www.pharmawebinars.com/darius-pillsbury/.
About Pharma Webinars
Pharma Webinars is revolutionizing the technical training experience for the pharmaceutical industry with a unique approach to designing and delivering live online training programs. All scheduled and privately delivered training sessions are offered exclusively as live, interactive, real-time experiences. To view the complete list of upcoming webinars, visit https://www.pharmawebinars.com/upcoming-live-webinars.
About ValSource
ValSource is the premier provider of consulting and advisory services for the biological, medical device, and pharmaceutical industries. The company specializes in program and project delivery
including capital project execution, procurement, commissioning, qualification and validation, compliance, and quality risk management – serving clients as advisors, trusted consultants, and
highly experienced program managers. ValSource is committed to helping projects get to a qualified and validated state with the most efficient solutions. To learn more, visit www.valsource.com.