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Roles and Responsibilities of the Qua...
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Roles and Responsibilities of the Qualified/Authorised Person 21 – 23rd Sept 2015
Upcoming Events & Interviews
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Aim: This subject is designed to provide the qualified (or authorised) person with key requirements for being able to release finished product (and APIs) for supply. It will include workshops to provide practical application of the key requirements. There will also be a number of tools provided to assist in the release for supply process. It will focus on Annex 16 of the EU GMP Guide, the EMA Template for the Qualified Person and the Guidance on Release for Supply by the TGA. Day 1 Examination and interpretation of EU and PIC/S GMP Regulations and Requirements Day 2 Release for Supply – theory, tools and workshops, including use of risk management Day 3 Authorised/Qualified Person and the Supply Chain

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