Strategies for 21 CFR Part 11 Cost Effective Compliance Using a Risk-based Approach
November 04 - 04, 2008
90 Minute Accredited Online Training
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This course is available as a client site course. Please click here for more information.
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