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Points to Consider When Doing an Annex 1 Self-Assessment – By Darius Pillsbury and Stephen Langille. December 8, 2020 | 10:30 AM – 12:30 PM | EST

ValSource senior consultants Darius Pillsbury and Stephen Langille will deliver a 2-hour live training event through Pharma Webinars to discuss this important document.

Led by two experts, 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. Among the specific topics to be discussed during the webinar will be 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, and aseptic processing simulation requirements.

Following this webinar, attendees will understand the major points of emphasis in Annex 1 with regard to the control of sterile product operations and be able to complete a basic self-assessment to gauge their preparedness for Annex 1 compliance.

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Environmental Monitoring and Sterility Assurance Control for Medical Devices and Combination Products

In this article for Pharmaceutical Online, ValSource Principal Consultants Melissa Stappen and Stephen Langille discuss the amount of environmental control, environmental monitoring, and finished product testing necessary to ensure medicinal product microbiological safety and product quality.

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Stephen Langille elected to US Pharmacopeia’s Compounding Expert Committee

Senior Microbiology Consultant Stephen Langille was recently elected to the United States Pharmacopeia’s Compounding Expert Committee for the 2020-2025 cycle. (USP). The role of this Expert Committee is to develop new and revise existing general chapters related to physical analysis (e.g., particles, powders, rheology).

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Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.