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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!
Unser modularer Qualifikationslehrgang zum Quality Manager im GMP-Bereich vermittelt Ihnen, wie Sie die zahlreichen Aufgaben und Herausforderungen des Qualitätsmanagements bewältigen.
Mit diesem Qualifikationslehrgang können Sie sich in allen Qualitätsmanagement/-sicherungs-Themen strukturiert weiterbilden und dabei fachliche Schwerpunkte auf Change Control, Variations, Validierung, Datenintegrität u.v.m. legen.
This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in (Non-)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 via Zoom.
To make the most of ICH Q12 opportunities you as a lifecycle manager have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering QbD.
