Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.. This seminar will analyze each of these necessary elements of the batch record review process.
Why You Should Attend:
- Recognize regulatory requirements for batch records and batch record review
- Discover the essentials of batch record reviewer qualifications and training
- Establish a working relationship between production and quality reviewers
- What to do when a batch fails to meet specifications (discrepancies and deviations)
Who Should Attend:
- Quality Assurance Departments
- Manufacturing Departments
- Production Departments
- Validation Departments
- Documentation Departments
- All professionals who review batch records