Risk-based approaches have gained considerably in importance in all branches in recent years. Pharmaceutical production, quality assurance and quality control would be unthinkable without them. Starting with the FDA initiative “cGMPs for the 21st Century” for the introduction of the risk-based approach, through the subsequent ICHQ9 guideline on risk management, which can now be found as Part III of the EU GMP guidelines, to the revised Annex 15 with a wealth of risk analyses, these principles are anchored everywhere. With the revision of Annex 1, risk management is also increasingly becoming part of the main guideline for the manufacture of sterile pharmaceutical products.
In this workshop on the principles, regulations and application of risk assessment in the context of contamination control, you will gain insight into the relevant underlying guidelines and guides as well as valuable pointers for practical implementation using practical examples. The following areas are covered:
General introduction on risk assessments
ICH Q8, Q9 and Q10 principles
How to apply risk assessments in contamination Control
Example of a Contamination Control Strategy
Interactive session: FMEA
Target Group
The workshop is designed for personnel of pharmaceutical companies, their suppliers and representatives of authorities with responsibilities in Contamination Control, Aseptic Manufacturing, Quality Assurance, Quality Control, Internal Quality Audits, External Inspections.
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
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Testimonials
Seminar Programme as PDF