In order to meet regulatory requirements even after changes in the manufacturing process of active ingredients or pharmaceutical and biotechnological products and thus to maintain the necessary GMP compliance, an effective change control system is required.
The transitional period for the new EU Medical Device Regulation (MDR) ends on 26th May. It will bring significant changes for medical device manufacturers launching their products on the European market.
Live Online Training "The GDP Audit" of the ECA Academy on 28 and 29 October 2020 with Dr. Martin Melzer, Principal Consultant at gempex, as main speaker.
Will Switzerland liberalise pharmaceutical cannabis? What would this relief mean regarding GACP and GMP? What role does Swissmedic play in this context?
Implementing and improving systems, meeting regulatory requirements | ECA live online training on 6/7 October 2020 | Highlight: ICH Guideline Q12 "Technical and regulatory considerations for the management of the life cycle of pharmaceutical products.“
IDEXX Switzerland GmbH had itself audited for its veterinary diagnostics by the independent company Bureau Veritas and thus obtained GMP certification.
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