Author: Jürgen Ortlepp
What is the key to a successful audit or inspection?
Good planning and preparation, smooth implementation, and finally, timely follow-up.
Get all the relevant basics or bring yourself up to date with this whitepaper regarding: definition of terms and audit types, regulatory basics and typical audit focuses.
If you are interested in further support on GMP-relevant topics, please contact us. We offer a wide range of training opportunities in the field, both for beginners and professionals.
Download now the white paper 'GMP audits and inspections'. We hope you enjoy reading it!
This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.
Would you like to feel more confident presenting your CMC/quality data clearly and in full compliance with regulatory standards? Our two experts will share their extensive regulatory expertise in "advanced" CMC writing with you, providing you with real-world examples and practical tools.
The conference will cover recent updates and practical implications of the EU pharmaceutical legislation, the application of AI in RA, and the new EU Variation regulation. Additionally, it will address the latest developments in quality (draft) guidelines: ICH M13a and M13B, ICH M4Q, EU GMP Annex 11, New Annex 22 on AI, and an update on the ongoing discussions on nitrosamine "contaminations".
