Session 1

• Introduction and Expectations
• Components of a Batch Record
• Regulatory Requirements

Session 2

• Elements of the Batch Record Review Process
• Skills and Responsibilities of Batch Record Reviewer
• Production and Quality Review Processes

Session 3

• Documentation Practices
• Electronic Batch Records
• Tools for Effective Batch Record Review

Session 4

• Preparing for the Batch Record Review
• Handling and Responding to Batch Record Deviations
• Industry Trends: Observations and Warning Letters

• Reintroduction and Recap
• Training Program for the Batch Record Reviewer

Session 2

• Metrics and Record Keeping

Session 3

• Writing Batch Record Review Procedures and SOPs

• Communication Between Production and Quality
• Questions, Issues, Expectations and Answers
• Course Wrap-up and Conclusions