Syed Imtiaz Haider'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

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

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484

Publisher

CRC Press

Published Date

ISBN 10

143985016X

ISBN 13

9781439850169

Environmental Management System ISO 14001: 2004

Handbook of Transition with CD-ROM

By: Syed Haider

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Environmental Management System ISO 14001: 2004

Handbook of Transition with CD-ROM

By: Syed Haider

Environmental Management System ISO 14001:2004 provides the information and practical know-how required to facilitate a smooth adoption and incorporation of the latest revisions and enhancements put forth by the International Organization for Standardization. This unique work shows how to adopt or transition to the documentation procedures required

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Page Count

599

Publisher

CRC Press

Published Date

ISBN 10

1439829403

ISBN 13

9781439829400

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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608

Publisher

CRC Press

Published Date

ISBN 10

1439826617

ISBN 13

9781439826614

Iso 9001

2000 Document Development Compliance Manual: A Complete Guide and CD-ROM

By: Syed Imtiaz Haider

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Iso 9001

2000 Document Development Compliance Manual: A Complete Guide and CD-ROM

By: Syed Imtiaz Haider

Don't reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM shows you how to develop and implement a documented quality management system based on ISO 9000 series standards. It supplies ready to use ISO 9001:2000 Templa

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Page Count

434

Publisher

CRC Press

Published Date

ISBN 10

1420025449

ISBN 13

9781420025446

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

Validation Standard Operating Procedures

A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

By: Syed Imtiaz Haider

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Validation Standard Operating Procedures

A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

By: Syed Imtiaz Haider

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

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Page Count

1144

Publisher

CRC Press

Published Date

ISBN 10

1420009419

ISBN 13

9781420009415

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

Pharmaceutical Vendors Approval Manual

A Comprehensive Quality Manual for API and Packaging Material Approval

By: Erfan Syed Asif

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Pharmaceutical Vendors Approval Manual

A Comprehensive Quality Manual for API and Packaging Material Approval

By: Erfan Syed Asif

This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications. This book provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements. Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.

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Page Count

110

Publisher

CRC Press

Published Date

ISBN 10

1000510026

ISBN 13

9781000510027

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

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Page Count

586

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CRC Press

Published Date

ISBN 10

1439886903

ISBN 13

9781439886908

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

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Page Count

608

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CRC Press

Published Date

ISBN 10

1439826617

ISBN 13

9781439826614

Validation Standard Operating Procedures

A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

By: Syed Imtiaz Haider

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Validation Standard Operating Procedures

A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

By: Syed Imtiaz Haider

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1144

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CRC Press

Published Date

ISBN 10

1420009419

ISBN 13

9781420009415

Pharmaceutical Master Validation Plan

The Ultimate Guide to FDA, GMP, and GLP Compliance

By: Syed Imtiaz Haider

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Pharmaceutical Master Validation Plan

The Ultimate Guide to FDA, GMP, and GLP Compliance

By: Syed Imtiaz Haider

The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.

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Page Count

208

Publisher

CRC Press

Published Date

ISBN 10

1574443305

ISBN 13

9781574443301

Book's by Syed Imtiaz Haider

Quality Control Training Manual

Quality Control Training Manual

Quality Control Training Manual

Quality Control Training Manual

Environmental Management System ISO 14001: 2004

Environmental Management System ISO 14001: 2004

Cleaning Validation Manual

Cleaning Validation Manual

Iso 9001

Iso 9001

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Validation Standard Operating Procedures

Validation Standard Operating Procedures

Biotechnology

Biotechnology

Pharmaceutical Vendors Approval Manual

Pharmaceutical Vendors Approval Manual

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Cleaning Validation Manual

Cleaning Validation Manual

Validation Standard Operating Procedures

Validation Standard Operating Procedures

Pharmaceutical Master Validation Plan

Pharmaceutical Master Validation Plan

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