Presentation of the new perspectives for the pharmaceutical industry linked to EU GMP Part I Chapter 3 and 5 about prevention of Cross contamination in Production, EU GMP Annex 15 Chapter 10 Cleaning Validation and the EMA Guideline 2018 “EMA/CHMP/CVMP/SWP/246844/2018”.
This webinar will present all new aspect of the latest regulatory text about pharmacological and toxicological approach with the new HBELs approach, Q&A and outcome associated:
Each document points will be developed and discussed. Comparison between each point will be treated to give to the participants the best view of the regulatory expected point.
Focus will be on the points that have not been retained or modified and the subjects that have been fleshed out or completed in the Q&A or outcome guideline.
The webinar will help people to understand the current context with the inclusion of toxicity data (PDE/ADE) in the calculation of cross-contamination acceptance limits, to understand the implementation of the different risk assessment expected to justify cleaning validation strategy and routine control and to be able to adapt technical and organisational measures for a good contamination management depending on the manufactured products
We will provide answers to the following questions:
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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