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Dietary Supplement companies and raw material suppliers are not exempt from the Foreign Supplier Verification Program (FSVP) requirements outlined in 21 CFR 1 subpart L. There are, however, modified requirements for companies that are following 21 CFR 111. In this one-hour course we will highlight the key requirements of the FSVP for raw material suppliers and dietary supplement companies. You will learn how the FSVP requirements are an extension of 21 CFR 111, as well as what you and your raw material suppliers need to do to be compliant with this part of the regulation. Understand what is required for FSVP Know who is considered to be an importer Understand how the requirements are modified for dietary supplements and dietary supplement components Know where the regulations are found Know when an onsite audit may be required Instructor: Jennifer Alfrey Please note a PDF of the presentation will not be distributed. You will have access to the recording for 15 days once you've completed your registration. Read More

Join us for this 1-hour training introducing the regulations governing the labeling of dietary supplements. This convenient online training focuses on how to create a compliant dietary supplement label as required by the FDA and FTC. At the end of this course you should be able to: · Identify the parts of a dietary supplement label that are mandated by the FDA · Understand how to structure a Supplement Facts table to ensure that it complies with the new labeling changes · Know the different kinds of claims available to you, and the criteria to use them · Avoid common labeling mistakes made by the dietary supplement industry · Know where to locate the resources available to you when generating a new dietary supplement label Instructor: Erin Taraborrelli Please note, a PDF of the recording will not be distributed. You will have access to the recording for 15 days once you've registered. Read More

Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. However, the FDA does not provide much guidance on how to qualify vendors. This class is designed for people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. Instructor: Jennifer Alfrey 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 compete your registration.  Read More

Bundle of 6 Courses - ISO 13485:2016 Overview and Country-Specific Medical Devices Regulatory Requirements for United States, Japan, Australia, Brazil, Canada A comprehensive overview of each countries' Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to market in each country and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how each country is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements. This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information regarding Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement. Read More

This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information regarding Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement. Read More

ISO 14971 states that manufacturers shall establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is considered an integral part of a manufacturer’s QMS. This course presents the key foundations of the risk management process as defined in ISO 14971 and provides expert tips on how to navigate the process. Read More

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