This article, published in The PDA WCC Insider, was authored by Senior Consultant Patrick Mains.

By: Steve Langille

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.