Examining Quality Assurance Regulation Requirements

A session at Quality Assurance Masters Training

• Review guidelines for quality systems and controls
- GMPs for this century
- Q9 Quality Risk Management
- Q7A API Guidelines

• Assess 21 CFR Part 11 (Electronic Records and E-Signatures)
• Understand quality guidelines in order to meet requirements
• Compare and contrast domestic and international requirements

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Date Wed 5th December 2012

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