Quality (Pharmaceutical Engineering Series)

Erscheinungsjahr 2002
ISBN: 978-0-7506-5113-4
Verlag: BUTTERWORTH HEINEMANN

Buch, Englisch, Band 2, 275 Seiten, Format (B × H): 178 mm x 256 mm, Gewicht: 816 g

Reihe: Pharmaceutical Engineering

The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership.

Zielgruppe

Companies and organizations including pharmaceutical, biotechnology, medical device, bulk/intermediate, and diagnostic manufacturers, architecture/engineering/construction firms, government agencies, universities, equipment manufacturers and suppliers, consultancy firms.

Individual functions within these organizations include project/facility/maintenance engineering, production/manufacturing, quality control/assurance, process development, microbiology, regulatory affairs, training, materials management, marketing and sales management, purchasing and corporate and product management.

Autoren/Hrsg.

Mccormick, Kate

McCormick, Kathleen E.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Verfahrenstechnik, Chemieingenieurwesen
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)
• Technische Wissenschaften Maschinenbau | Werkstoffkunde Produktionstechnik Industrielle Qualitätskontrolle

Inhaltsverzeichnis

Quality Life CycleQuality Assurance and Quality ControlQuality SystemsGood Manufacturing PracticeManagement of QualityCost of QualityQualified PersonTechnology TransferCalibrationAuditing/InspectionsPharmaceutical MicrobiologyQuality Improvement ProgrammesQuality Tools and Techniques

Über Autor(innen)

McCormick, Kathleen E.
Dr. Kate McCormick is a pharmaceutical manufacturing consultant and trainer who has worked extensively with both regulators and companies in more than 50 countries. She is the author of a number of textbooks, and she was an editor of GMP Review and International Education Advisor for ISPE. Dr. McCormick has a degree in biochemistry, a doctorate in microbiology, and is also a Master of Business Administration.