Leveraging Your NSF Certification: Now that you've received NSF Certification ... why not leverage the Mark to your advantage.
NSF offers several training courses to keep you up to date on everything you need to know to comply with good manufacturing practice (GMP) regulations for dietary supplements.
Our courses help your company meet and exceed regulatory standards to assure customers and regulators that supplements are manufactured safely, reliably and traceably. Our instructors are industry experts and knowledge leaders in GMP issues.
Upcoming courses include:
This class helps companies of all sizes shine in a U.S. FDA inspection of the manufacturing, packaging, labeling, holding and distributing of dietary supplements.
Ensuring the most positive outcome from a good manufacturing practice (GMP) inspection requires careful planning and preparation, successful management of many issues during the inspection and thorough follow-up. The course goes in-depth into the regulations and guidelines, using real-world examples that take each participant through the different phases of an FDA audit, demonstrating tools and techniques for successfully managing an inspection.
The NSF GMP overview course is a must for companies that want to know what the actual laws require and where they are found. It also provides insight into the why behind GMPs and how to apply their principles to specific situations.
Instructor: Nicole Leitz is a senior partner at Validation & Compliance Institute and has led regulatory projects for many clients, large and small, since 2002. She has held many management positions in FDA-regulated industries, including three vitamin production facilities at BASF.
Upcoming Sessions:
Supplier and vendor qualification is a crucial component of the FDA’s good manufacturing practice (GMP) requirements for dietary supplements. Supplier qualification principles also apply to subcontracted services affected by GMPs, such as manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.
This course helps companies meet and exceed FDA requirements by defining the specifications and requirements for all goods or services being purchased, and showing companies how to produce evidence that these requirements are being fulfilled.
Since the evaluation of suppliers of all types often involves auditing, the course also incorporates a fresh look at the auditing process and the skills and techniques necessary to get the most from these activities. These skills are independent of the type of auditing or the standard being audited, so they are applicable to conducting internal audits as well as performing audits of suppliers.
Instructor: Bill Kracht has provided auditing services for NSF since 2005, and previously led a consulting, training and auditing business. Kracht is a frequent speaker and trainer at quality conferences and a three-time past chairman of the International Conference on ISO 9000 and Related Standards.
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Good manufacturing practices (GMPs) for dietary supplements (21 CFR 111) require manufacturers and brand owners to produce and keep formal master manufacturing records (MMRs) and batch production records (BPRs). The U.S. FDA requires each batch of every unique dietary supplement to have an MMR.
An MMR is the specific set of instructions, or “recipe,” a company must create for the production of a batch of dietary supplements. For each batch, a copy of the MMR is filled out, signed and dated by the people involved in the production of that specific batch. This completed copy becomes the BPR that documents the who, when and how of the production.
Deficiencies in MMRs and BPRs are among the most frequently cited non-conformances during audits and inspections. This course examines the common pitfalls with MMRs and BPRs, and provides specific guidance on how to avoid these problems, including creating templates or different BPRs and MMRs as necessary. We’ll also cover best practices to streamline and improve internal operations.
Instructor: Bill Kracht has provided auditing services for NSF since 2005, and previously led a consulting, training and auditing business. Kracht is a frequent speaker and trainer at quality conferences and a three-time past chairman of the International Conference on ISO 9000 and Related Standards.
Upcoming Session:
