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

21 CFR 111 GMP Dietary Supplement in Spanish - Recorded Session The FDA expects all companies that manufacture, package, or store dietary supplement products to follow 21 CFR 111, Current Good Dietary Supplement Manufacturing Practices (cGMP).  Combining extensive industry experience and a concrete understanding of regulations with flexible and convenient training, this course provides a solid understanding of the cGMP and the responsibilities expected of various individuals and groups within the company. You will learn how to apply cGMP principles to specific situations. The 21 CFR 111 GMP training is interactive, with hands-on exercises including case studies of recent warning letters. Bring your questions and be prepared to interact with the instructor and your peers in the industry.  This dietary supplement GMP training course provides an overview of subparts A-P of Regulation 21 CFR 111, including: • Specifications • Manufacturing master records/batch production records • Quality Authority and FDA • Warning letters • How to make sense of complex regulations in an understandable and comprehensive way • How to effectively turn regulations into real-world examples and scenarios delivering clarity and operational success • How regulations can be applied to your organization cost-effectively   Please Note: Once you have completed your registration, you will have access to the recording for 30 days. A PDF of the presentation will not be available. A Certificate of Participation will be issued once the course assessment is successfully completed. Costo: $499.00 USD    Read More

Dietary supplement manufacturers may be exempt for the preventative controls requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this one hour webinar we will highlight the aspects of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what new cGMP requirements found in subpart B of 21 CFR 117 are required for dietary supplement manufacturers and are now an extension of the cGMP requirements in 21 CFR 111. This webinar will help you learn how to determine which parts of 21 CFR 117 apply to dietary supplement manufacturers and to raw material suppliers. Instructor: Jennifer Alfrey A PDF of the presentation will not be 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

Food defense is a new area of compliance for the food industry which includes dietary supplement manufacturers. In this one-hour course we will cover the aspects of 21 CFR 121 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what a food defense plan is and what is meant by intentional adulteration. • Understand what a food defense plan is • Know where to find the new regulations • Understand how to perform a vulnerability assessment • Understand how intentional adulteration in the dietary supplement industry is covered under the food defense regulation • Know how this new regulation in 21 CFR 121 impacts Dietary Supplement Manufacturers and raw material suppliers.   Once you've completed your registration, you will have access to the recording for 15 days. Please note PDF's of the presentation will not be available. Certificate of participation are not issued for recorded courses​. Read More

21 CFR 111 Dietary Supplement CGMP Overview  This course provides an overview of 21 CFR 111, the Dietary Supplement CGMPs. This abridged course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, investigations and a brief overview of the relevant subparts. We will also review the proper way to execute GMP records, detail the personal hygiene requirements, examine the meaning of master and batch records for control of production, labeling and packaging, clarify the requirements of quality and, describe the purpose of GMP rules, regulations and FDA enforcement. o Personnel o Buildings and Facilities o Equipment o Facility Records o Production and Process Control o Holding and Distribution o Batch Records o Packaging and Labeling o Quality Control and Quality Assurance o Laboratory Operations o Product Complaints · The role of the FDA and their authority The roles and responsibilities of the Quality Unit As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. Instructor: Shawn Ludlow Once you've completed your registration, you will have access to the recording for 15 days. Please note PDF's of the presentation will not be available. Certificate of participation are not issued for recorded courses. Read More

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