Most regulatory agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, in order to demonstrate compliance, there must be written procedures for a batch record review process.
The production and manufacture of pharmaceuticals, biologics, medical devices, etc., involve critical processing parameters. In order to properly document these processing parameters, a strong batch record review system is essential.
This webinar will analyze each of these necessary elements of the batch record review process. Upon completion of this session, you will learn the fundamentals for reviewing batch records in a pharmaceutical environment. You will hear about the proper training that must be demonstrated to be considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.
- Recognize regulatory requirements for batch records and batch record review
- Understand the essential and necessary qualifications and training of batch record reviewers
- Establish a working relationship between production and quality reviewers
- What to do when a batch fails to meet specifications (discrepancies and deviations)
- Parameters of efficient review of batch records good documentation practices, compliance to essential quality attributes and critical processing parameters
- Skills and responsibilities of an effective batch record reviewer
- Tools to achieve an effective batch record review
- Ensuring Production and Quality reviewers coincide with their reviews
- Creating an extensive training plan for batch record reviewers and when they can be considered qualified to review a record
- Quality Assurance Departments
- Manufacturing Departments
- Production Departments
- All professionals who review batch records