Stability testing for APIs and Finished Products MasterClass – Overview EU requirements

Professional stability testing is based on a profound knowledge of all regulatory and scientific necessities, which are the content of this masterclass. As stability testing is GMP-relevant respective processes and QA measures are often questioned during inspections.

17-18 October, 2023, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

Stability testing of active pharmaceutical ingredients and medicinal products is a central topic that is important for both successful marketing authorisation and GMP compliance. From planning and execution to evaluation and reporting, questions about details and strategic concepts regularly arise. Professional stability testing is based on a profound knowledge of all regulatory and scientific necessities, which are the content of this masterclass. As stability testing is GMP-relevant respective processes and QA measures are often questioned during inspections. In this respect, it is of crucial importance to know exactly the diverse requirements for the different types of stability studies.

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RECOMMENDATION

Who should attend?

• People in charge for stability testing for small molecule APIs
• People in charge for pharmaceutical development and stability testing of medicinal products
• Regulatory Affairs Personnel
• Heads personnel of quality control units and QC laboratories
• EU Qualified Persons