Authors

Syed Imtiaz Haider earned his PhD in chemistry and is a quality assurance and environmental specialist with over 20 years experience in aseptic and nonaseptic pharmaceutical processes, equipment validation, and in-process control and auditing. Dr. Haider is currently involved in several major biotechnology-based tasks, including cell-line qualification, process validation, bioanalytics, method validation, biosimilar comparative studies, organizing preclinical studies, and preparing the Central Technical Dossier (CTD) formatted for regulatory submission. Dr. Haider is the author and coauthor of more than 20 research publications in international refereed journals dealing with products of pharmaceutical interest, their isolation, and structure development. A professional technical writer, Dr. Haider has authored more than 2000 standard operating procedures based on FDA regulations, ISO 9001:2000, and ISO 14001:2004 standards. He is a certified Quality Management System (QMS) auditor of International Register of Certificated Auditors (IRCA) and a registered associate environmental auditor for Environmental Association of Registered Auditors (EARA). He has written more than 10 quality system manuals for multidisciplinary industries and provided consultancy to the Drug Control Laboratory of the Ministry of Health in the United Arab Emirates in developing a quality management system based on ISO 9003 and later transition to ISO 9001:2000.

Dr. Haider works as a quality affairs director at Julphar, Gulf Pharmaceutical Industries, and is involved in the preparation of several abbreviated new drug application (ANDA) files, which, after successful FDA, EU, and GMP inspections, will lead to the export of finished pharmaceutical products to the United States and European markets. He has also written ISO 9001:2000: Document Development Compliance Manual: A Complete Guide and CD-Rom and Pharmaceutical Validation Master Plan, The Ultimate Guide to FDA, GMP, GLP Compliance and Validation Standard Operating Procedures and Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry. Dr. Haider holds the intellectual copyright certificate of registration on an electronic documentation package on ISO 9000 and ISO 14001 from the Canadian Intellectual Property Office. He is also a contributing author of chapters on ISO 9001:2000 and ISO 14001 in international publications.

Dr. Haider has organized cGMP conferences in the region, resourcing competitive speakers from Europe, Canada, and the United States.

Erfan Syed Asif earned his PhD in organic chemistry and has expertise in various areas under the quality operations umbrella with 15 years of experience in pharmaceutical industries in Asia and North America. Dr. Asif currently holds the position of quality control manager in Gulf Pharmaceutical Industries. He has vast experience working in the U.S. FDA and Health Canada approved facilities in managerial positions, where his responsibilities included the administrative routine of the quality control laboratory, investigating and responding to market complaints, advisory to production and introduction of new products, and conducting annual requalification of analytical instruments. Dr. Asif has extensive experience in overseeing qualification projects for manufacturing equipment, utilities, systems, sterilization techniques, aseptic processes simulation, and sterile and nonsterile products manufacturing processes.

As a validation consultant he provided guidance on projects at Pharmacia Upjohn (Michigan), Glaxo Smith Kline (Canada), and Air Liquide, Canada (medical gas manufacturers) based on Health Canada and U.S. FDA regulations. He also provided extensive validation training to groups of validation specialists working in Canada and the United States.

Dr. Asif is the author of many research publications in various internationally published chemistry journals and conference proceedings.

Dr. Asif is also a regular appointee of the Board of Advanced Research and Studies of Karachi University, Pakistan, as an external examiner for thesis evaluation and viva voce of M.Phil and PhD degrees in pharmaceutical chemistry.

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