EU GMP Volume 4 - An Update on Annex 1 & How to Develop an Effective Contamination Control Strategy

Upcoming

Virtual Learning
November 10, 2020

Italia

1 day

Register
Virtual Learning
June 22, 2021

1 day

Register

About This Course

International regulators and industry experts agree that the most economic and effective way of assuring the sterility of your products is through a contamination control strategy (CCS). This interactive one-day course takes a deep dive into how you can generate a CCS to help you mitigate risk and improve product quality.

How can you ensure that your strategy for contamination control meets the requirements of EU GMP Volume 4 Annex 1 and helps you to drive down quality risk, non-compliance and waste? Join us on this course to gain insight into the cGMP expectations of EU GMP Volume 4 Annex 1, including how to generate an end-to-end contamination control strategy that balances precautions to risk.

If you choose our virtual learning option, training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent to you following registration.

Purpose of the Course

Understanding the background, derivation and specific requirements of Annex 1 will enable your colleagues to ensure compliance to cGMP, and a phased implementation of any required changes. This course emphasizes the priorities and clarifications in Annex 1, including any likely future interpretations.

The contamination control strategy (CCS) is a document that identifies and assesses risk, explores the mitigating options and defines the preventive actions that may be associated with the full range of sources of viable contamination of sterile products. This document consolidates all the measures found in the pharma quality system that contribute to sterility assurance and evaluates their effectiveness and resilience.

Preparing, evaluating and deploying the CCS is a key step in meeting cGMP and providing effective sterility assurance. This course provides practical guidance and examples so that your CCS is proactive and comprehensive in its approach.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • An overview of changes in the new Annex 1 as well as their implications and how to interpret them
  • Team creation, methodology, format and content in preparing the CCS (we provide a detailed guide)
  • Expectations of regulatory bodies regarding the CCS and how they will use it to assess compliance with the cGMP of your sterile facility

Who Should Attend

QA, production, microbiology and technical services professionals and anyone tasked with reducing the common risks in sterile production.

Course Tutor

John Johnson - Vice President at NSF, John Johnson has vast experience in preparing sites for regulatory GMP inspections, preparing or remodeling bio pharma and steriles facilities, installing quality systems and helping companies embed the right culture for long-term sustainable growth. A passionate educator, John has a track record of improving service and margin to ensure perpetual GMP inspection readiness.

Discounts

Discounts offered to NHS staff, regulators and charities.