ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track!
GAMP® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the 2023 ISPE Annual Meeting and at several local GAMP® events held around the globe. At the upcoming 2023 ISPE Europe Annual Conference, you will have an excellent opportunity to hear about GAMP® 5 directly from the authors, discuss the content of the guide with peers and regulators, and ask all the questions you did not get answers to until now. As technologies continue to evolve and are being adopted by the pharmaceutical industry at the same time when companies are facing new challenges like pandemics, supply chain issues and drug shortages, it has become even more important that validation approaches smartly address the risks to Patent Safety, Data Integrity, and Product Quality. Computer System Validation should not be a hindrance to innovation. On the contrary, it should enable innovation by ensuring that systems are fit for the intended purpose without creating an excessive documentation burden. It should ensure that investments into novel solutions will improve quality and efficiency in the development, manufacturing, and distribution of treatments that we all might need at some time. This is why validation can never be an exercise in mindlessly filling in templates and completing checklists. Validation is about thinking things through, assessing risks carefully and making justified decisions. This is what GAMP 5 is all about!