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TOP 5 GMP Downloads

1. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.

 

3. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.

 

4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.

 

5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance

 

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You need GMP information that is reviewed by GMP experts and is guaranteed reliable. Our advisory board includes members from US, Europe and Japan. They supervise the content and development of the GMP MANUAL. More than 50 experts around the world write articles that are peer-reviewed. You get the best GMP information when you need it.

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Author

Study of law at Ruhr-University-Bochum
First and Second State Law Examination at OLG Düsseldorf graduated as Doctor of Law
(4 semester of math and physics at University Essen; geriatric nursing assistant)

Attorney at law and specialist solitor at medicinal law, founder of the Law Office Lücker MD-Law

since 1998: medical device law
Teaching: law relating to economic offences, medicinal law and criminal law as a scientific assistant on a legal chair at Ruhr-University-Bochum; speaker at the University of Augsburg and in several training sessions (TÜV Akademie; Eurocat, PTS, Atrium ex Atrio, Akademie of Heidelberg, MedInform; BVMed a.o.)

Publications: e.g. : Orthopädie im Profil, Medizin & Technik and Arthroskopie; adjudication of the OVG NRW regarding reprocessing of medical devices, ambulant operieren 2008, 76; conflict between medical device law and the law of the health insurance, NZS 2007, 401; EuGH and problems of demarcation, MPJ 2007, 189; combination of equipment, MTD 2007, 74; medical devices and medicinal products, MPR 2006, 77

Co-editor of the german journal "Medizinprodukte Journal" and the reference book "Schorn, Kommentar zum Medizinprodukterecht"

Commentator of the chapter medical devices law in the reference book „Spickhoff, Medizinrecht, Gesamtkommentar"

Member of German Attorney Association for Medical Law; German-American-Lawyer-Association and a part of BVMED e.v. (national association of medical device manufacturer)

Publications at Maas & Peither GMP Publishing: