This course is designed to provide an overview of US regulatory requirements for advertising and promotion of medical devices, with a focus on FDA as well as the corresponding standards, policies, procedures, and guidelines that apply to advertising and promotional activities. Upon completion of this course, learners will understand how advertising and promotion are defined, the required elements of advertising and promotional materials including on social media platforms, roles and responsibilities, and the regulatory risks associated with advertising and promotional activities. Read More

Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and CAPA. It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard. Note: Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.     Read More

According ​to ​the ​Dietary ​Supplement ​Health ​and ​Education ​Act ​(DSHEA), ​any ​company ​that ​sells ​a ​dietary ​supplement ​containing ​a ​new ​dietary ​ingredient ​must ​submit ​a ​New ​Dietary ​Ingredient ​Notification ​(NDIN) ​to ​the ​FDA. ​In ​this ​course ​we ​will ​provide ​guidance ​on ​how ​to ​determine ​when ​an ​NDIN ​is ​required, ​what ​kind ​of ​information ​you ​will ​need ​to ​include ​in ​an ​NDIN, ​and ​common ​pitfalls. ​The ​course ​is ​directed ​toward ​dietary ​supplement ​and ​food ​ingredient ​manufacturers ​and ​suppliers ​who ​are ​interested ​in ​understanding ​the ​basic ​requirements ​for ​NDINs ​so ​they ​can ​better ​communicate ​with ​regulators ​and ​specialists. Specific topics will include: • How to determine whether you need to submit an NDIN to the FDA • How to decide what kind of testing is required for an NDIN • How to establish safety under the conditions of intended use • How to compile the necessary documentation for a successful FCN • How to avoid common pitfalls associated with preparing an NDIN Instructor: Brad Lampe Please note a PDF of the recording will not be available. You will have access to the recoding for 15 days once you complete your registration. Certificate of participation are not issued for recorded courses​. Read More

Dietary Supplement. Join us for a comprehensive virtual training, designed to build consumer and retailer trust in verified label claims by earning the sought-after “butterfly” logo for your products and ingredients. Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will: Learn how to help products stand out in the category with this collaborative 2-hour workshop for Non-GMO Project Verification, focusing on: Defining risk levels Classifying ingredients Identifying specific requirements for common dietary supplement ingredients Facility level compliance requirements Work through common sourcing and ingredient challenges with hands on exercises and case studies Make sense of complex regulations so they can be applied to your organization’s formulations and ingredients Become an in-house expert at Non-GMO Project definitions, standards and requirements Instructor: Marci Burton 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 self-paced digital learning course provides comprehensive instruction on Pharmaceutical Microbiology in pharmaceutical manufacturing.   The program is presented in three modules: - approximate course completion time = *5 hours. Once you finish the first module, you will automatically begin the next module within this course.   Module 1 - Introductory Topics – approximately 1 hour At the end of this module, you will: Explain Microbiological problems in the context of pharmaceutical manufacturing, including how to identify problems Learn the meaning of Microorganisms in their significance Understand HOW microorganisms grow and WHY it matters   ​Module 2 - Intermediate Topics – approximately 2.5 hours      At the end of this module, you will be able to: Review how microorganisms are counted and explain the rapid microbiological methods Outline the Identification of Microorganisms and explain pharmaceutical water systems Review Pyrogens and pyrogen testing Understand microbiological evaluations of raw materials Understand microbiological contamination and spoilage Learn the principles of preservation in the pharmaceutical context Understand Antibiotics and how to assess antimicrobial activity Outline and understand the importance of good disinfection practices   Module 3 - Advanced Topics – approximately 1.5 hours      At the end of this module, you will be able to: Review sterilization principles and methods Explain bio validation of sterilization Describe sterility testing in the pharmaceutical environment Discover Microbiological validation of cleanrooms Review Microbiological Environmental monitoring methods Learn how to perform a microbiological risk assessment *The course is self-paced so completion times are approximate, based on the amount of content in each section. Read More

Post-market surveillance for manufacturers is covered in EU MDR Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements set forth in these articles in detail, with expert advice provided throughout the course. Read More