Upcoming Sessions

The pre-submission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA. Read More

Dietary Supplement companies and raw material suppliers are not exempt from the Foreign Supplier Verification Program (FSVP) requirements outlined in 21 CFR 1 subpart L. There are, however, modified requirements for companies that are following 21 CFR 111. In this one-hour course we will highlight the key requirements of the FSVP for raw material suppliers and dietary supplement companies. You will learn how the FSVP requirements are an extension of 21 CFR 111, as well as what you and your raw material suppliers need to do to be compliant with this part of the regulation. Understand what is required for FSVP Know who is considered to be an importer Understand how the requirements are modified for dietary supplements and dietary supplement components Know where the regulations are found Know when an onsite audit may be required Instructor: Jennifer Alfrey 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

Although dietary supplement manufacturers may be exempt from the preventative controls and supply chain program requirements of 21 CFR 117, raw material suppliers are not and many dietary supplement companies also manufacture products, such as meal replacements that are foods. These companies are not exempt and are required to have a written supply chain program as part of their food safety plan. In this one hour webinar we will highlight the key requirements of 21 CFR 117 subpart G that are required for all raw material suppliers and any manufacturer that makes a product with a Nutrition Facts label. You will learn how the FSMA based supply chain programs have in common and differ from the supplier qualification requirements of 21 CFR 111, as well as what you and your raw material suppliers need to do to be compliant with this part of the regulation.   Instructor: Jennifer Alfrey 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

This self-paced learning course provides comprehensive instruction on the general drug or Pharmaceutical cGMP and Quality Systems requirements.   This course utilizes real-world scenarios to instruct on the practical application of these requirements, embedded video and audio content, engaging knowledge checks throughout each module, and a final competency assessment. The program is presented in three modules: - approximate course completion time = *5 hours 1. Introductory Topics – approximately 1 hour Provides the history of GMPs and Basic Food and Drug Law to include discussion about USP, NF, Code of Federal Regulations, the FDA and the FD&C act.  This section also outlines basic concepts of Pharmaceutical Quality Systems and GMPs, explaining basic principles of a Quality Management Systems in relationship to the commercial product lifecycle.  In this section, students will also learn the importance of quality integration and basic concepts of GxPs and QMS principles and the seven principles in pharmaceutical manufacturing throughout the lifecycle of each product. 2. Intermediate Topics – approximately 2.5 hours This section includes instruction on: Quality Culture, Quality Systems, People, Data Integrity, Documentation and Records, Elements of Procedure and GMP, Fundamental of GDP Requirements, Materials Management Controls, Change Management, Change Control and Continuous Improvement.   3. Advanced Topics – approximately 1.5 hours This section includes instruction on: Quality Risk Management, Measuring Success: GMP, Audits and Self Inspection, Batch Release System, Deviation and Human Error, Complaints, Quality Defects and Recalls.    *Time is approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner. Read More

Join us for this 1-hour training introducing the regulations governing the labeling of dietary supplements. This convenient online training focuses on how to create a compliant dietary supplement label as required by the FDA and FTC. At the end of this course you should be able to: · Identify the parts of a dietary supplement label that are mandated by the FDA · Understand how to structure a Supplement Facts table to ensure that it complies with the new labeling changes · Know the different kinds of claims available to you, and the criteria to use them · Avoid common labeling mistakes made by the dietary supplement industry · Know where to locate the resources available to you when generating a new dietary supplement label Instructor: Erin Taraborrelli Please note, a PDF of the recording will not be distributed. You will have access to the recording for 15 days once you've registered. Certificate of participation are not issued for recorded courses​. Read More

Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. However, the FDA does not provide much guidance on how to qualify vendors. This class is designed for people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. Instructor: Jennifer Alfrey 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 compete your registration.  Certificate of participation are not issued for recorded courses​. Read More

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