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New Book On Systems-Based Audits From Start To Finish: “Audit And Control For Healthcare Manufacturers”


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Audits are an important part of quality assurance and the
quality management system (QMS). They verify the effectiveness of a QMS and acts as a
hands-on management tool for achieving continual improvement. This book helps guide you
through:

  • GMP and ISO 9001 Requirements and Processes
  • Systems-Based Audits and Inspections
  • Defining Metrics
  • Risk Based Approach to Quality Auditing
  • Auditor Techniques
  • Documentation and Reporting Techniques
  • Computerized Systems Audits and Data Integrity Requirements

Also included: Auditing Cleanrooms, Culture Media, Sterile Facilities and many more relevant
discussions including a complete plan for Auditing the Microbiology Laboratory. This text is an
indispensable guide and reference for all healthcare manufacturers. This book is available in
both print and PDF formats. Site Licenses are available.

About the Authors: Dr. Tim Sandle, Head of Microbiology and Sterility Assurance at Bio
Products Laboratory, UK, has over 25 years experience of microbiological research and
biopharmaceutical processing. In addition, he is a visiting tutor with the School of Pharmacy
and Pharmaceutical Sciences, University of Manchester.

Jennifer Sandle is an experienced auditor of quality systems (GMP and ISO 9001), laboratory
operations, and, the Quality Assurance Manager at the National Institute of Biological Standards
and Control, which is part of the U.K. Medicines and Healthcare products Regulatory Agency.

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