The new version of the GMPs Annex 1 published by the European Commission on 22 08 2022 has major updates, in both its structure and its content. This session guides you through the main new requirements by explaining change of Mindset (Quality Assurance and Sterility Assurance based on Quality Risk Management Approach), supporting by the international experience of the trainer specialized on coaching for preparation of audits and inspections of numerous Sterile Pharmaceutical Companies.
This interactive training will be supported by many examples and group discussions around Sterile manufacturing issues. The new version of EMA Annex 1 of Eudralex vol. 4 will accurately reviewed and each new expectation will be deciphered and analyzed to be translated into operational terms.
Passing in Review all the chapters by focusing on main topics and identifying operational impact of these regulatory change:
The course will be illustrated from specific situations met by the speakers in Pharmaceutical companies.
The course will be illustrated from specific situations met by the speaker in Pharmaceutical companies.
The main objective of this session is to have an exhaustive overview and a full understanding of the position of European inspectors and auditors regarding the new Annex 1.
This training is intended for Company Executives and Managers of Department involved such as Quality Assurance, Sterility Assurance, Production, Facilities, Engineering, Auditors, Qualified Persons and all support functions involved in Contamination Control Strategy.
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