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Pharmaceutical and Medical Device Validation by Experimental Design
Language: en
Pages: 272
Authors: Lynn D Torbeck
Categories: Medical
Type: BOOK - Published: 2007-06-26 - Publisher: CRC Press

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This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory
Validation by Design
Language: en
Pages: 200
Authors: Lynn D. Torbeck
Categories: Experimental design
Type: BOOK - Published: 2010 - Publisher:

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Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry
Language: en
Pages:
Authors: Eugenia Gabriela Carrillo-Cedillo
Categories: Drugs
Type: BOOK - Published: 2022 - Publisher:

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"This book gives the reader an up-to-date overview of the medical device manufacturing process and its influence on current regulations highlighting the importa
Leachables and Extractables Handbook
Language: en
Pages: 702
Authors: Douglas J. Ball
Categories: Science
Type: BOOK - Published: 2012-01-24 - Publisher: John Wiley & Sons

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A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Pac
Solid Oral Dose Process Validation
Language: en
Pages: 99
Authors: Ajay Babu Pazhayattil
Categories: Medical
Type: BOOK - Published: 2018-11-16 - Publisher: Springer

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Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, W