Upcoming Sessions

See All Upcoming Sessions

Module 3 of our Data Integrity Series Data Integrity Module 1, Basics of Data Integrity addressed what everyone needs to know for this essential topic.  Module 2 went beyond the basics focusing on the technical details for subjects such as auditing and computer systems management. In this third Module we build on your essential knowledge to understand what the Senior Management should ensure is in place, in use and effective. Read More

The FDA is aware of some confusion surrounding the guidance, Deciding When to Submit a New 510(k) for a Change to an Existing Device. As such, FDA has worked diligently over the past few years to enhance predictability, consistency and transparency while maintaining a “least burdensome approach.” The new updated guidance provides greater detail of the regulatory framework, policies and practices underlying FDA’s decision-making process and provides much needed clarity for industry on FDA’s expectations. In this course we walk through these changes and discuss how to determine when to submit. Read More

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

Course Description: This virtual instructor-led two-day training is highly interactive and provides an in-depth understanding of the risk management and design/development regulatory requirements relative to FDA’s 21 CFR 820, ISO 13485:2016 and EU MDR. The course provides practical examples and knowledge to assist in all phases of design and development projects. At the end of the course, you will: Recognize risk management definitions and principles of ISO 14971; Identify how risk management affects quality management system practices; and Recognize regulatory expectations relative to Design Control requirements. 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

Shopping Cart

Your cart is empty