In this 1-hour course, we will discuss the latest trends in FDA observations during their inspections of dietary supplement manufacturers. Discuss the Top 10 items that manufacturers are cited for, to help you in mitigating your risk and identifying non-conformances ahead of time. At the conclusion of this training participants will have an understanding of: • How to use the Code of Federal Regulations, Pharmacopoeias, and Guidance Documents as source information. • Who is the FDA and what power do they have? • How the FDA communicates with the company and how you should communicate with the FDA. • The top 10 items that dietary supplements manufacturers are cited for; and MOST IMPORTANTLY— The steps you can take to avoid each one of them! Instructor: Nicole Leitz 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 includes six modules. The first five modules cover the U.S. Quality Systems Regulation (21 CFR 820) and the sixth module covers the Regulation of Combination Products (21 CFR Part 4). Each module includes an approximately one-hour video instructional presentation by Kim Trautman, Executive Vice President, Medical Device International Services at NSF International, followed by an assessment on the information covered in the video. Read More

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

In this approximately 30-minute self-paced course, you will be introduced to the importance of writing effective nonconformity statements during audits of medical device manufacturer quality management systems. Learners will identify the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit and identify tools and tips for writing effective nonconformity statements. Learners will also demonstrate how to assess nonconformity statements to confirm they are free from opinion and bias.   Who Should Attend This online course is vital for anyone who conducts or manages internal, supplier or third-party audits within the medical device manufacturing space. The tools and tips shared in this training will help ensure that the auditee organization clearly understands the nonconformities, so that they can identify and implement effective investigations and subsequent containment, correction, corrective action and systemic corrective actions, as appropriate. Read More