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 webinar will analyze each of these necessary elements of the batch record review process.
- Regulatory Requirements for Batch Record Review
- What to look for while reviewing batch records, i.e Good Documentation Practices, Compliance with Critical Quality Attributes, and Critical Processing Parameters
- Skills and Responsibilities of an Effective Batch Record Reviewer
- Tools for Effective Batch Record Review
- Ensuring Production and Quality Reviewers Coincide with their Reviews
- Extensive Training plan for Batch Record Reviewers and when they can be considered "Qualified" to Review a Record
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).
- Quality Assurance Batch Record Reviewers
- Production Personnel
- Production Managers who Review Batch Records
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