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!
The online seminar with details on development, quality, CMC, approval and market access for advanced therapy medicinal products. Secure your place in our virtual seminar via Zoom.
Get know-how on the LATEST CHANGES (EECC 114) in the EAEU Upgrade Procedure - This online training provides you with in-depth knowledge on Regulatory Affairs, CMC and GMP requirements in EAEU countries.
Are you looking for comprehensive expertise to prepare your company's IT for external controls in a compliance-compliant manner with regard to validation processes? On the other hand, do you want to organise the corresponding workflows as efficiently as possible? Get the tools you need to successfully implement your validation projects in our seminar!
Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration of the archiving system into your daily work processes. The three experts will show you some practical approaches to typical pitfalls.
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.