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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
July 15, 2010 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This course is designed for professionals in the pharmaceutical and medical device industries and those involved with clinical research within these areas. It will be especially beneficial to:
• IT Managers
• Regulatory/QA Managers and Directors
• Managers of automated laboratories, automated
manufacturing systems and automated clinical
testing/analysis systems
• Managers of computerized medical devices
Description
The FDA requires that computer systems involved with the generation, processing, storage or analysis of regulated data conform to 21 CFR Part 11, which provides guidance for system validation; archiving and storage, audit trails, (optional) electronic signatures and data integrity.
This 90-minute accredited online training course provides an overview of the requirements of 21 CFR Part 11 and provides a strategy for cost effective compliance.
Module 1: Overview of 21 CFR Part 11
• Background of the regulation
• Cost as an access issue
– Components of cost
– Minimizing unnecessary regulatory burdens
• Major Components
– System validation
– Audit Trails
– Archiving
– (Optional) electronic signatures
– Data integrity
Module 2: A Risk Based Approach to Cost Effective Compliance
• Risk as the defining characteristic
• A Multi-tier standard
• Low, Medium and High Risk situations
– Full validation
– Data integrity checks
– Audit trails
– Electronic signatures
– Archiving with confirmation
– Basic Validation
– Bare bones validation
Module 3: A Strategy for On-Going Control of Computer Systems
• Risk factors
– Frequency; severity
• Steps
– Inventory of systems
– Adoption of multi-tier plan
– Categorization of systems
– Progress toward compliance
• Summary; New developments
• Key issues
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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