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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
October 26, 2010 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training is intended toward professionals in the Pharmaceutical, Biologics and Medical Device industries. It will be especially valuable to Regulatory managers, Production managers, IT managers and their staff members. Any personnel wishing to learn more about the basics and the future trends of GAMP will benefit from this training. Description
As the production environment, laboratory, and quality processes of the pharmaceutical, medical device, and biologics industries become increasing automated, regulatory agencies throughout the world are struggling to keep up with appropriate controls of computer systems. The Good Manufacturing Practices (GMPs) are quickly evolving into Good AUTOMATED Manufacturing Practices (GAMPS).
This 90-minute accredited training course follows the efforts of the USFDA, the EU's EMEA, Australia's TGA, and other agencies to update and develop appropriate GAMPS that will both provide a template for today's automated systems and remain sufficiently flexible to handle tomorrow's developments. This course reviews those efforts, identifies the key elements of GAMPs, and looks at the future developments on the immediate horizon.
Module 1: Automating the GMPs:
• Need for computer-related regulations
• US GMPs + 21 CFR Part 11
• EMEA GAMPs (GAMP5)
• Moving toward harmonization
Module 2: The Key Elements:
• Audit trails
• Electronic signatures
• Automated QA/QC: PAT
• Data Integrity
• Validation
Module 3: GAMP Future:
• QbD
• More Automation = general guidelines
• US: New GMPs incorporating automation
Question and Answer Session
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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, Associate Professor of Health Care Management (Regulation) at Clayton State University, part of the Georgia State University System; retired regulatory professional from the drug, device and vaccine industries.
Dr. Weinberg is teaching and researching Regulation and Biodefense. He is a consultant to the FDA regulated industries and is a former consultant to the FDA and other international regulatory agencies including Health Canada, NIH, CDC, EMEA and the Swiss Ministry of Health.
He has been a leader in the field of system validation for more than twenty years, and a practitioner in regulatory submissions, auditing, international liaison and biodefense vaccine development. Dr. Weinberg is the author of numerous books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, Good Laboratory Practice Regulations, and The Handbook of Drug Regulatory Submissions. His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.
Dr. Weinberg is a member of the Board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands. Recently retired, Dr. Weinberg was Senior Director for Biodefense at GE Healthcare and Vice President of Tikvah Therapeutics; as well as an investor in and Board member of several international biomedical companies.
Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas. Recent projects include the auditing and certification of a chromatography control system; a business development and fund raising project for a biodefense vaccine company; an Orphan Drug submission; and the validation of a Laboratory Information Management System. Much of Dr. Weinberg’s practice is centered in the US, Western Europe and Israel.
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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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