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The Center for Professional Advancement, An Online Training Format
November 4, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
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
- Managers of automated laboratories, automated manufacturing systems and automated clinical testing/analysis systems
- Regulatory/QA Managers and Directors
- 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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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Sandy Weinberg; IIndependent Consultant to FDA Regulated Industries and former consultant to the FDA, Health Canada, NIH, CDC, EMEA, and the Swiss Ministry of Health
Dr. Sandy Weinberg has been an international consultant on system validation and 21 CFR Part 11 for more than twenty years. He has worked with the USFDA and equivalent agencies in Europe, Asia, and South America to develop clear and achievable standards, and is the author of five chapters on Part 11 in industry texts. He currently serves as a professor of Healthcare Management (Regulation), and as an independent consultant to the industry and regulatory agencies.
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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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info@cfpa.com
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