Syed Erfan Asif's Books

Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

By: Syed Imtiaz Haider,Syed Erfan Asif

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Quality Control Training Manual

Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories

By: Syed Imtiaz Haider,Syed Erfan Asif

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences

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Page Count

484

Publisher

CRC Press

Published Date

ISBN 10

143985016X

ISBN 13

9781439850169

Biotechnology

A Comprehensive Training Guide for the Biotechnology Industry

By: Syed Imtiaz Haider,Anika Ashtok

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Biotechnology

A Comprehensive Training Guide for the Biotechnology Industry

By: Syed Imtiaz Haider,Anika Ashtok

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnolo

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Page Count

868

Publisher

CRC Press

Published Date

ISBN 10

1420084496

ISBN 13

9781420084498

Cleaning Validation Manual

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

By: Syed Imtiaz Haider

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Cleaning Validation Manual

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

By: Syed Imtiaz Haider

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-

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Page Count

608

Publisher

CRC Press

Published Date

ISBN 10

1439826617

ISBN 13

9781439826614

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

By: Syed Imtiaz Haider,Erfan Syed Asif

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Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

By: Syed Imtiaz Haider,Erfan Syed Asif

To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.

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Page Count

586

Publisher

CRC Press

Published Date

ISBN 10

1439886903

ISBN 13

9781439886908

Book's by Syed Erfan Asif

Quality Control Training Manual

Quality Control Training Manual

Biotechnology

Biotechnology

Cleaning Validation Manual

Cleaning Validation Manual

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

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