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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

1994-1999 graduate engineer, Physics, Hochschule Ravensburg-Weingarten (University of applied science)

1999-2001 Vetter Injekt System GmbH & Co. KG., Ravensburg, Validation: Concept and implementation of computer system validation; validation of production and laboratory systems and equipment; Audit Support, retrospective computer system validation, project management support

2001-2003 Propack Data GmbH - Rockwell Automation, Karlsruhe, Quality Project Management: Quality Project Manager GMP projects, electronic batch recording systems (EBR), Quality Release Management und application development, support Quality Management and auditing

2003-2006 Invensys Validation Technologies, Montreal, Kanada, Senior Validation Consultant: Several global compliance projects and validation services (USA, Europe, Asia), Audit Management, Project Manager, Coaching and Trainer

2006-2009 Systec & Services, Karlsruhe, Director Compliance Management: Director Compliance Management/Quality Management System, Quality Assurance, Medical device consultant, DMS and IT infrastructure qualification

since 2009 comes compliance services, Ravensburg, Management: Independent Consultant and Auditor; Business Management Compliance Projects and Support, Audit Service Center, GMP Projects

2003-2011 Trainer at Pharma-Trainingsservice (PTS), Arnsberg

2007 Founder and Member of "IT Pharma Validation Europe"

since 2008 ISPE (International Society of Pharmaceutical Engineering) Ambassador for the DACH affiliates (Germany - Austria - Switzerland)

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of Chapter 9 Computer System Validation, chapter 15.F Electronic Batch Recording and Batch Release and chapter 15.G Document Management Systems)
  • Computer System Validation - PDF Download
    (Chapter 9 of the GMP MANUAL for Download)