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This video-based training course provides a basic understanding of design controls for medical devices and IVDs. It covers how to comply with the U.S. FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016 and EU MDR. Learn from global quality systems expert Kim Trautman, a former U.S. FDA official. Read More

Dietary Supplement. New products are essential to win in the marketplace. However, if new product launches are plagued with quality and operational issues, it will blemish the brand and erode customer and consumer trust. It is absolutely critical we get it right from the start. In this seminar, we will examine how to design quality into products during the product development process to effectively mitigate quality and operational risks at product launches. This course will provide a fresh look at understanding the major contributors of variation and ways to control and mitigate their impact on product quality. We will also highlight how to achieve product and operational excellence with speed-to-market in the product development process. · Understand the key elements to win in the marketplace · Review the barriers to winning · Examine how to remove these barriers by designing for quality · Identify the key contributors of variation and ways to mitigate them Instructor: Jones Chan 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. Certificate of participation are not issued for recorded courses. Read More

The labeling and promotion of your dietary supplement products are the most visible ways that the Food & Drug Administration and the Federal Trade Commission can track your compliance with federal regulations. A perfect complement to “Introduction to Product Labeling for Dietary Supplement”, this course will go over in detail each type of permitted claim that is available to you and the criteria for making each one. We will cover FDA and FTC standards for substantiation, how to build the substantiation for each claim that the FDA and FTC requires you to hold to ensure your claims are accurate and not misleading, and how you can avoid making implied claims which could lead to regulatory enforcement. Participants will learn how public knowledge of FTC and FDA enforcement actions affect business performance, enforcement/litigation trends and other responsibilities of dietary supplement manufacturers such as structure/function claim notification. Instructor: Erin Taraborrelli 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

This course provides comprehensive instruction on the EU IVDR. It covers all aspects of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU IVDR, standard requirements that must be met by all IVD manufacturers, and pre- and post-market requirements of conformity assessment.​ Read More

This course provides comprehensive instruction on the EU MDR. It covers every aspect of the regulation and identifies key topics and changes, including economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.   Read More

In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary. The Quality System Inspection Technique, QSIT, is the primary tool used to conduct FDA inspections of medical device manufacturers.  QSIT is publicly available and will be the primary focus of this module. Read More

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