Batch Production Record (BPR) and Master Manufacturing Record (MMR)
What you'll gain from this course
Live online sessions with industry-recognised experts
Engaging group discussions and activities
Join from anywhere - no travel required
Hands-on exercises and real-world application
Join us for an interactive, hands-on training designed to provide you with practical tips to help improve efficiency in your master manufacturing record (MMR) and batch production record (BPR) processes. This course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training.
Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will:
- Take part in a collaborative training developed to streamline the MMR development processes, focusing on:
- The difference between an MMR and a BPR
- The regulatory requirements for MMRs for dietary supplements
- FDA requirements for BPRs
- Gain specific guidance to help manage and avoid common issues and pitfalls with MMRs and BPRs.
- Learn best practices to simplify and improve your internal operations, enabling your batch records to withstand audits and inspections.
Learning Outcomes
- Regulatory requirements for MMRs for dietary supplements
- The difference between an MMR and a BPR
- FDA requirements for BPRs
- Citations from recent warning letters
- Creation and use of a BPR
- Examples of best (and less-than-best) practices
- Tips to improve your company’s MMRs and BPRs
Who Should Attend
- Management
- Manufacturing
- Sanitation supervisor
- Quality control/assurance
- Packaging
- Marketing
- Laboratory operations
- Auditing
- Suppliers and distributors
- Regulatory affairs
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