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 online 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. Full Training agenda: • The 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 the Batch Production Record • Examples of best (and less-than-best) practices • Tips to improve your company’s MMRs and BPRs Please note certificates are issued for recorded sessions. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification Read More

Botanical Identification - Macroscopic, Microscopic and Organoleptic Techniques  In this section, you will learn about: Herbs in supplements Brief overview of Good Agricultural and Collection Practices and Good Manufacturing for Botanical Materials Specifications 21 CFR Part 111 Subpart E 111.70 Establishment of specification for identity, purity, strengths and composition Subpart J 111:320 Requirements for laboratory methods for testing and examination Subpart E 111.75 Meeting specifications/test methods Selecting scientifically valid methods Botanical identification, adulteration Review organoleptic characterization Instructor: Holly Johnson Note: A PDF of the presentation will not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration.  Certificate of participation are not issued for recorded courses. Read More

Botanical Identification - Methods in Chemistry Designed to provide an overview of the guidance on testing methodology, specifications for botanicals. Combining extensive industry experience and real-world case studies with flexible and convenient training, participants in this course will receive an overview of: Adulteration in botanicals   Complexity within botanicals Variations Reference materials Evaluation tools Spectroscopic techniques Chromatographic techniques Spectrometric techniques Spectroscopic techniques Genomic techniques Instructor: John Travis A PDF of the presentation will not be not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration.  Certificate of participation are not issued for recorded courses​. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Brazil is utilizing MDSAP. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Canada is utilizing MDSAP. Read More

This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements. China’s medical device regulation program has evolved rapidly over the past two decades. This two-hour overview covers the changes and key aspects of the regulations as they pertain to both domestic and overseas manufacturers. Read More