How to Develop an Effective Pharmaceutical Contamination Control Strategy
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. This interactive one-day course takes a deep dive into how you can develop a contamination control strategy to help you mitigate risk and improve product quality.
How can you ensure that your strategy for contamination control meets the requirements of the revised 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 how to generate an end-to-end pharmaceutical contamination control strategy that balances precautions to risk.
The 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
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.
Learning Outcomes
On completion of this contamination control strategy 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.
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