About this course
Formal Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) have long been required in the pharmaceutical world, but the new Good Manufacturing Practices for dietary supplements (21 CFR 111) bring these requirements to this industry as well. Deficiencies in MMRs and BPRs are among the most frequently cited during audits or inspections, including those from FDA. This course will examine common issues and pitfalls with MMRs and BPRs and provide specific guidance on how to avoid these problems. Best practices will also be highlighted to enable your batch records not only to withstand audits and inspections, but to streamline and improve your internal operations.
Who Should Attend
This course will be useful to anyone involved in the creation, review, and/or approval of master manufacturing records (MMRs), or the creation, review, and/of approval of batch production records (BPRs) for individual lots of dietary supplements [including packaging activities]. It would also be valuable for those who have management responsibilities for any of these activities.
Course outline
- What the FDA has to say about MMR and BPR requirements through the GMP itself
- What the FDA has to say about MMR and BPR requirements through recent Warning Letters
- The purpose and audience for MMRs – and what that says about doing them right
- Critical factors and considerations to optimize your MMRs for your organization
- Key tips to get your BPRs complete and accurate the first time and every time
- Advice for optimizing the BPR review and approval process
What You Will Learn
- Understand the FDA regulatory context for MMRs and BPRs – what is required, and the logic behind those requirements.
- Analysis of the Master Manufacturing Record and the process for creating them – critical factors to address to make your MMRs complete, relevant, focused, and streamlined, so that they drive an effective and efficient BPR process each time a batch of product is created.
- Creation and use of the Batch Production Record – best practices and common shortcomings [and how to avoid those shortcomings in your organization’s BPRs].
- Tips for reviewers and approvers of both MMRs and BPRs, to make those processes both thorough and efficient.
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice. Additionally, discussion periods will provide delegates with plenty of time to obtain answers to their specific questions and concerns.
Venue
Carlsbad, California
Hyatt House Carlsbad (formerly known as Summerfield Suites)
Hyatt House San Diego/Carlsbad
5010 Avenida Encinas
Carlsbad, California 92008
United States
Located on the coast of beautiful Carlsbad, California and conveniently situated only 2½ blocks from the beach, HYATT house™ San Diego/Carlsbad is surrounded by the area’s many great attractions. Enjoy a five-minute shuttle ride to Legoland or the Village of Carlsbad or travel a short 35 miles to the San Diego Convention Center, SeaWorld, San Diego Zoo, San Diego Wild Animal Park, Old Town or the San Diego airport.
Hotel Accommodations
For more information on special room rates, please contact the Hyatt House at 760-929-8200 and mention NSF-DBA training. Special rates may be available for up to 30 days in advance of the training session.
Tutors
Your trainer for this course has been specially selected for his extensive experience in compliance of GMPs in the dietary supplement industry. Through various NSF and industry roles he has seen supplier issues from all angles. Bill has also personally trained over one thousand auditors, led hundreds of audits, and observed hundreds of first-, second-, and third-party auditors at work, giving him a unique perspective on the subject of auditing. In addition to this hands-on background, he has consistently developed and delivered training material on cGMP requirements.
What you've said
h4. “NLI is always working to implement the most stringent quality systems and looking for opportunities to prove the superiority of its systems. DSQP certification with NSF-DBA has been another way for NLI to show a commitment to being a CMO of the highest quality. Investment in training ensures your company is in compliance and manufacturing safe products for the public”
Jera’le Smith, Director of Quality Assurance, Nutritional Laboratories International (NLI)
“I attended both NSF-DBA’s FDA inspection Readiness and Corrective Action Management modules and our company assiduously implemented the recommendations made. I am absolutely convinced that doing so was one of the primary reasons our company did not receive an FDA Form 483 following an FDA unannounced 4-day GMP inspection”
Kim Randall Pearson, General Counsel, Thorne Research, Inc.
An NSF International Company