Course description
EU GMP Volume 4 - An Update on Annex 1 & How to Develop an Effective 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 (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.
Upcoming start dates
Suitability - Who should attend?
QA, production, microbiology and technical services professionals and anyone tasked with reducing the common risks in sterile production.
Training Course Content
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
Course delivery details
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Discounts
Discounts offered to NHS staff, regulators and charities.