The new version of Annex 1 has major updates, in bothstructure and content.
This session guides you through the changes, point by point.
This interactive training will be supported by many examples and group discussions around Sterile manufacturing issues. The new draft of EMA Annex 1 of Eudralex vol. 4 will be will be accurately reviewed and each new expectation will be deciphered and analyzed to be translated into operational terms .
The course will be illustrated from specific situations met by the speakers in Pharmaceutical companies.
The main objective of this session is to have an exhaustive overview and comprehension of the new draft of the Annex 1 published on February 2020.
This training is intended for personnel categories such as Quality Assurance, Sterility Assurance, Production, Facilities, Engineering, Auditors, Qualified Persons and all support functions involved in contamination in sterile environments.
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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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