Regulatory agencies expect firms to keep written procedures for production and process controls, known as batch records, and for the process used to review them. This 60-minute batch record review training walks through each element of a compliant review system.
A strong review process documents every critical processing parameter in the manufacture of pharmaceuticals, biologics and medical devices. You'll learn what to look for when reviewing a record, including good documentation practices, compliance with critical quality attributes and critical processing parameters.
The session also covers the skills and tools reviewers need, how production and quality reviews should line up, how to train reviewers until they are qualified, and what to do with discrepancies and deviations before product release.
WHY SHOULD YOU ATTEND?
Weak batch record review can let documentation errors and out-of-specification batches slip through to release. This session helps you meet regulatory requirements and build a review process that holds up.
It suits quality assurance batch record reviewers, production personnel and production managers who review batch records and need a consistent approach shared by production and quality.
AREA COVERED
- Regulatory requirements for batch records and batch record review
- What to check: good documentation practices, critical quality attributes and critical processing parameters
- Skills and responsibilities of an effective batch record reviewer
- Tools for effective batch record review
- Keeping production and quality reviews aligned
- A training plan for reviewers and when they count as qualified
- Handling batches that fail specifications: discrepancies and deviations
LEARNING OBJECTIVES
- Recognize regulatory requirements for batch records and their review
- Check batch records for good documentation practices, CQAs and critical processing parameters
- Define the qualifications and training a batch record reviewer needs
- Build a working relationship between production and quality reviewers
- Respond correctly when a batch fails to meet specifications
WHO WILL BENEFIT?
- Quality Assurance Batch Record Reviewers
- Production Personnel
- Production Managers who Review Batch Records
Weak batch record review can let documentation errors and out-of-specification batches slip through to release. This session helps you meet regulatory requirements and build a review process that holds up.
It suits quality assurance batch record reviewers, production personnel and production managers who review batch records and need a consistent approach shared by production and quality.
- Regulatory requirements for batch records and batch record review
- What to check: good documentation practices, critical quality attributes and critical processing parameters
- Skills and responsibilities of an effective batch record reviewer
- Tools for effective batch record review
- Keeping production and quality reviews aligned
- A training plan for reviewers and when they count as qualified
- Handling batches that fail specifications: discrepancies and deviations
- Recognize regulatory requirements for batch records and their review
- Check batch records for good documentation practices, CQAs and critical processing parameters
- Define the qualifications and training a batch record reviewer needs
- Build a working relationship between production and quality reviewers
- Respond correctly when a batch fails to meet specifications
- Quality Assurance Batch Record Reviewers
- Production Personnel
- Production Managers who Review Batch Records
