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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

In addition to providing an in-depth discussion of contemporary design and development principles and practices (and corresponding EU and FDA regulatory requirements), this approximately four-hour, self-paced course explores the essential relationships between risk management and design and development throughout the lifecycle of a medical device.  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 will help you understand the basics of auditing and gain a basic understanding of how to conduct an internal audit focused on cGMP and other FDA requirements. It incorporates internal audit best practices, regulatory requirements and information on how to turn internal audit findings into useful information. Requirements for 21 CFR 111, supplier programs and FSMA requirements are incorporated into the course. You’ll learn how to prepare, perform, report and close an audit, as well as discussions on the importance of using CAPA systems as follow-up to your internal audit findings. It is ideal for new auditors, those preparing to be on an audit team, and people who will soon be audited to understand the auditing process. It is also great for those who are looking to develop or improve their current internal audit programs • Internal Audit Basics and Best Practices – Introduction to Internal Auditing – Using Checklists – Conducting the Audit • Incorporating Regulatory and cGMP Requirements in Internal Auditing – 21 CFR 111 and 21 CFR 117 for warehousing and distribution – Supplier Program Requirements – Records and Procedures • Turning Audit Findings into Useful Information and Continuous Improvement – Communicating Audit Reports – Importance of a good CAPA system  Instructor: Jennifer Alfrey  Please Note: Once you've completed your registration, you will have access to the recording for 30 days. Please note a PDF of the presentation will not be available. Certificate of participation are not issued for recorded courses.   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

This course provides a greater understanding of the key requirements outlined in the EU MDR for medical device technical documentation. Learners will be able to conceptualize the regulatory requirements and the Notified Body expectation for technical documentation, helping to reduce unnecessary delays to the certification process. The content in this course supports the creation of compliant and Notified Body-friendly technical documentation. Read More

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