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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition (2 Volume Set)
  
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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition (2 Volume Set) [Loose Leaf]

Leonard Steinborn (Author)

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Loose Leaf, June 27, 2003 $499.95  
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Book Description

June 27, 2003 0849318491 978-0849318498 6

The world's most widely recognized QA manual has been updated to provide the audit system readers need to assess their compliance with new standards and regulations and those that continue in effect. This indispensable toolkit includes checklists that simulate FDA QSIT audits. The new edition-two volumes plus a software package-continues a two-decade tradition of providing expert guidance on performing successful audits and provides easy, objective, and quantifiable results for management track and trend compliance. Comprehensive in its coverage, this practical guide is an invaluable resource that offers effective training for new auditors and updates current auditors on new standards and regulations.


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Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
individual manufacturing quotas, estimated net disposal, such basic class, prescribing individual practitioner, freight forwarding facility, narcotic raw material, registered individual practitioner, aggregate production quota, master production instructions, possible labor strikes, member bodies casting, contract acceptor, drug product containers, fiber optic parts, quota pursuant, narcotic treatment program, audit program procedures, contract giver, audit team leader, management with executive responsibility, audit program objectives, sterile medicinal products, laboratory control records, intermediate manufacturer, registrant pursuant
Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Special Agent, Drug Enforcement Administration, Federal Register, Government Representative, Qualified Person, Department of Justice, Registration Unit, Cosmetic Act, Federal Food, Air Force, Administration Controlled Substances Code Number, International Electrotechnical Commission, Post Office Box, Public Health Service, Native American Church, Coast Guard, European Community, Marine Corps, Field Division Office of the Administration, National Formulary, Quality of Biotechnological Products
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