21 CFR Part 111 - Master Manufacturing Records and Batch Production Records 2022

21 CFR Part 111 - Master Manufacturing Records and Batch Production Records 2022

The single most critical document in an FDA inspection is the master manufacturing record and associated batch production record. While the 21 CFR Part 111 regulations have a checklist of elements the documents must contain, it can be difficult to translate that into a working document. This training will review the basic principles of what an MMR & BPR must contain and give you tools to create an “FDA Acceptable” document.

Areas Covered in the Webinar:

• The contents an MMR must contain
• The contents a BPR must contain
• Translating the regulatory requirements into a workable document that is quality and production friendly
• What quality, warehouse and production responsibilities should be in an MMR
• The required special instructions and corrective actions
• How to present and record information in the MMR & BPR
• What the creation process (flow chart) should look like
• Identifying which departments should be involved in the creation of an MMR

Who Will Benefit:

• Dietary supplement manufacturers
• Employees involved in the creation of an MMR & BPR
• Quality, Manufacturing and R&D/PD departments
• Executives responsible for the MMR & BPR