Batch Production Record (BPR) and Master Manufacturing Record (MMR) Training
About This Course
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.
Key Learning Obejectives
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
Who Should Attend?
- Management
- Manufacturing
- Sanitation supervisor
- Quality control/assurance
- Packaging
- Marketing
- Laboratory operations
- Auditing
- Suppliers and distributors
- Regulatory affairs
Instructor
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.
Additional Recommended Courses
21 CFR 111 Dietary Supplement GMP Overview Intro
This course provides an overview of 21 cCFR 111, the Dietary Supplement CGMPs. This abridged course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, investigations and a brief overview of the relevant subparts. We will also review the proper way to execute GMP records, detail the personal hygiene requirements, examine the meaning of master and batch records for control of production, labeling and packaging, clarify the requirements of quality and describe the purpose of GMP rules, regulations and FDA enforcement.
o Personnel
o Buildings and Facilities
o Equipment
o Facility Records
o Production and Process Control
o Holding and Distribution
o Batch Records
o Packaging and Labeling
o Quality Control and Quality Assurance
o Laboratory Operations
o Product Complaints
· The role of the FDA and their authority
· The roles and responsibilities of the Quality Unit
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Dates: December 5, 2024 & December 6, 2024
Time: 1:00 P.M to 5:00 P.M Eastern Time
Cost: $900.00
Course Prerequisites: None
*Register 3 or more attendees from the same company and receive a 10% discount off each registration*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.
Internal Auditing Training for Dietary Supplement
This course is 8-Hours. This dietary supplement internal auditing course will help you understand the fundamentals of auditing and how to conduct an internal audit focused on cGMP and other FDA requirements. The training incorporates internal audit best practices, regulatory requirements and information on turning internal audit findings into useful information. Requirements for 21 CFR 111, supplier programs and FSMA are incorporated into the content.
You’ll learn how to prepare, perform, report and close an audit and discuss the importance of using CAPA systems as a follow-up to your internal audit findings.
Part 1 - October 17, 2024 1:00pm.-5:00pm Eastern Time
Part 2 - October 18, 2024 1:00pm-5:00pm Eastern Time
Cost: $600.00
*Register 3 or more attendees from the same company under the "General Registration" type, and receive a 10% discount off each registration*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.
21 CFR 111 Dietary Supplement GMP Overview
This training course is 16-Hours split over 3-days. FDA expects all companies that manufacture, package, or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement CGMPs. This course provides a basic understanding of CGMPs and the responsibilities expected for various individuals and groups within the company. Participants will learn how to apply CGMP principles to specific situations. The course is interactive, with hands-on exercises including case-studies from recent Warning Letters.
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Course Prerequisites: None
Date: November 13, 2024
Time: 12:00 pm to 5:00 pm Eastern Time
Date: November 14, 2024
Time: 12:00 pm to 5:00 pm Eastern Time
Date: November 15, 2024
Time: 12:00 pm to 6:00 pm Eastern Time
Cost: General Registration $1200.00
*Register 3 or more attendees from the same company and receive a 10% discount off each registration*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.