Risk Assessment in Contamination Control - Live Online Training
Thursday, 29 September 2022 9 .00 - 15.30 h
Course No. 19612
Speakers
Arjan Langen
GE Healthcare
All times mentioned are CEST.
Objectives
Risk-based approaches have considerably gained 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 Live Online Training 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 course 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
Technical Requirements
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Testimonials
Seminar Programme as PDF