EU GMP Volume 4 - An Update on Annex 1 & How to Develop an Effective Contamination Control Strategy
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.
Richard Funnell - Richard spent 11 years with the MHRA, including seven as a Senior GMP Inspector with the lead for IMPs. Richard has special expertise in the knowledge of sterile manufacture and the manufacture of IMPs. Richard also spent seventeen years within a large pharmaceutical manufacturer in a variety of production and QA roles, including the manufacture of tablets, oral liquids, and sterile products (including aseptically filled lyophilised vials).
Discounts offered to NHS staff, regulators and charities.
A-Z of Sterile Products Manufacture
Whether you need to meet EU, FDA or other regulatory agency’s needs, this course provides the knowledge, skills and tools to succeed.
Quality Risk Management
This highly interactive workshop provides tools and techniques to improve your decision-making skills and better protect your company and the patient.
Designed to provide the knowledge and understanding needed to be able to assess microbiological risks in the pharmaceutical manufacturing environment.