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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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Experts

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.

Our panel has the right background and credentials to make sure that we provide the highest level of expertise and knowledge to the industry:

 

Author

1994–1998 Bachelor of Science in Biochemistry, Minor in Chemistry, University of Rochester, Rochester, NY

1999 Graduate Coursework at the Worcester Polytechnic Institute, Worcester, MA (Operations Management & Medical Device Quality & Regulations)

1998–2003 KMI/Parexel Consulting, Manager Equipment Qualification (Laboratory, Production, Filling, Packaging and Labeling), Process Validation (Biologics) and Computer Systems Validation (Lab Equipment, DCS, PLC, HVAC, LIMS, SAP, EDMS etc.) across Pharmaceuticals, Biologics and Medical Device industries. Compliance Audits, GMP Assessments & Supplier Qualification Assessments

since 2003 Clarkston Consulting, Regulatory & Compliance Manager: Delivery of strategy and solutions for regulatory compliance in FDA and EMEA regulated pharmaceutical, biotech, and medical device industries (business process improvement, product development, quality systems, and change management). Global project management in the areas of Regulatory and Quality Experience in implementing systems like LIMS, Packaging and Labelling, Clinical Trials Sample Tracking etc. Leader of the “Statutes and Regulations” Center of Excellence for two years; currently leading the “Regulatory Planning and Remediation” Business Solution within Clarkston.

1996–2004 Active membership within Professional Societies (ISPE, PDA, RAPS), Speaker at the Pharma Med Device Conference (2008) and the PDA/FDA Conference (2009), Participation at the Executive Development Program offered through the Northwestern Kellog School of Management on Regu-latory Strategy and Leadership.
Ms. Mukherji has earned the US Regulatory Affairs Certification (RAC) distinction.

Publications at Maas & Peither GMP Publishing:
  • GMP MANUAL
    (Author of chapter 11 Production)
  • Production - PDF Download
    GMP MANUAL Chapter 11 for Download