Batch Production Record (BPR) and Master Manufacturing Record (MMR) Training

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.

At the end of the course, you will know and understand:

• 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

• Management
• Manufacturing
• Sanitation supervisor
• Quality control/assurance
• Packaging
• Marketing
• Laboratory operations
• Auditing
• Suppliers and distributors
• Regulatory affairs

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.