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CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
30 November-2 December 2011
Who Should Attend
This course will be of particular value to individuals responsible for:
• Pharmaceutical and Biologics Manufacturing, Laboratories
• Medical Device Systems Development
• System Quality Control
• System Management and Development
• Computer System Validation Description
The FDA’s regulation 21 CFR Part 11 has been designed and updated to provide guidance for the use and validation of computer systems utilized in the pharmaceutical, device, and biological industries. The application of a testing methodology is of particular importance in design, operation and quality control of manufacturing and laboratory systems, where computers are integrally used in product control and inventory tracking.
This course is designed to provide the necessary skills for mastering the principles and techniques of developing and implementing a system validation and testing plan for computer systems. The course uses a combination of lecture/discussions, case studies, and multimedia presentations to provide a living case of a computerized pharmaceutical system in need of a validation plan for cGMP information systems. The program will take participants stepby- step through the process of developing and implementing that plan, and will conclude with a session adapting the plan to each participant’s unique environment and products.
Features of the Course Include:
Specification of a methodology for meeting FDA and PMA guidelines for manufacturing systems involving computers
Practical experience in applying that methodology to actual computerized manufacturing systems
Comparison of FDA computer guidelines with EMEA, TGA, ANVISA, Kiro Shu, and other regulatory agencies worldwide
New update on 21 CFR Part 11
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Dr. Sandy Weinberg; Senior Journal Editor, CLINICAL RESEARCH AND REGULATORY AFFAIRS, Professor of Regulatory Affairs, Clayton State University (Atlanta)
Dr. Sandy Weinberg, Senior Editor of the international journal CLINICAL RESEARCH AND REGULATORY AFFAIRS, is a professor of regulation the the largest United States Health Care Management program, Clayton State University. He has serves as VP, Regulatory, TIKVAH Therapeutics, and is former Sr. Director, Fast Trak Vaccines, GE Healthcare and has been the leader in the field of system validation for more than twenty years. He has consulted to the FDA, most other regulatory agencies worldwide, and the industry on techniques for assuring data quality and control since first identifying significant data problems in 1976. Dr. Weinberg is the author of numerous system validation books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, and System Validation Annual.His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.
Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas related to system validation. Recent projects include the auditing and certification of a chromotography control system; auditing and advisory services related to a pharmaceutical inventory system; and validation of a Laboratory Information Management System (LIMS).
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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