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Committee Member of the Pharmaceutical Microbiology Interest Group (Pharmig), Copyright © 2020 Elsevier, except certain content provided by third parties, Cookies are used by this site. 0000152644 00000 n
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If you decide to participate, a new browser tab will open so you can complete the survey after you have completed your visit to this website. 0000152149 00000 n
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Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC, Presents the latest developments in both regulatory expectations and technical advancements, Provides guidance on statistical tools for risk assessment and trending of microbiological data, Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks, COVID-19 Discipline-Specific Online Teaching Resources, Peer Review & Editorial Office Management, The Editor's Role: Development & Innovation, People In Research: Interviews & Inspiration. Please enter a star rating for this review, Please fill out all of the mandatory (*) fields, One or more of your answers does not meet the required criteria. startxref
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He is also is an elected member of the General Chapters Microbiology Expert Committee of the Unites States Pharmacopoeia 20152020 revision cycle. 0000018428 00000 n
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Tim Sandle, PhD, is a chartered biologist and holds a first-class honours degree in Applied Biology, a Master’s degree in education, and a doctorate from Keele University in the UK. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig). 0000212718 00000 n
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David Roesti, PhD, works at Novartis Pharma AG in Stein, Switzerland, and is responsible for defining the microbial control strategy at the site and is a global subject matter expert in microbiology for the Novartis group. 0000151434 00000 n
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Dr. Sandle has written over 550 book chapters, peer reviewed papers and technical articles relating to microbiology; he has also authored the books Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals, and Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control. This is a dummy description. Would you like to change to the United States site? 0000126494 00000 n
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Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of 0000021839 00000 n
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495, 15.6 Quality and Documentation in Drug Manufacturing 499, 16 Practical Guide for Microbiological QA/QC of Non‐sterile Pharmaceuticals Manufacturing for EU 505Ina Bach, 16.3 Audit Assessment Tools of a Microbiological Laboratory 508, 16.4 Regulatory Audits in the Microbiology Department 514, 17 Which Microbiological Tests Can Better Be Performed In‐house and What Can Be Easily Outsourced 519Thomas Meindl and Ingo Grimm, 17.2 Advantages and Disadvantages of Outsourcing 522, 17.5 Quality Agreement Between the Contract Laboratory and the Requesting Company 529. Hydrocarbon Utilization/degradation by Bacteria, Good Microbiological Practices (GMIP ) In A Pharmaceutical Microbiology Laboratory. 0000036164 00000 n
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Edition 8 (1995) of the Bacteriological Analytical Manual (BAM-8) contained numerous …