Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing by Roesti, David

Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing (Hardcover) (ISBN-13: 9781119356073)

Vendor: David Roesti
Product type: Books
Format: Hardcover
$200.95
$200.95
$200.95
Subtotal: $200.95
Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing by Roesti, David

Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing

$200.95
Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing by Roesti, David

Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing

$200.95
Format: Hardcover
Description
Description
x

Relying on practical examples from the authors' experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals.

  • 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


Author: David Roesti
ISBN-10: 1119356075
ISBN-13: 9781119356073
Publisher: Wiley
Language: English
Published: 01/02/2020
Pages: 592
Format: Hardcover
Weight: 2.35lbs
Size: 9.10h x 6.10w x 1.20d
By David Roesti
By David Roesti
x

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. He is also is an elected member of the General Chapters Microbiology Expert Committee of the Unites States Pharmacopoeia 2015-2020 revision cycle.

Marcel Goverde, PhD, runs MGP Consulting GmbH for consulting, training and project management in GMP-relevant areas with a focus on microbiology, hygiene and deviation management. He is the Swiss expert in the EDQM group for Modern Microbiological Methods since 2003, which was then integrated into Group 1 (Microbiological Methods and Statistical Analysis) in 2015.

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