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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

This course provides a comprehensive overview of 21 CFR 111 - Current Good Manufacturing Practices (cGMPs) for Dietary Supplements. Comprised of four modules, this course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, and investigations; as well as an overview of the relevant subparts. This course also reviews the proper way to execute GMP records, details personal hygiene requirements, examines the meaning of master and batch records for control of production, labeling and packaging, clarifies the requirements of quality, and describes the purpose of GMP rules, regulations and FDA enforcement. As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis. Module 1 of this course covers the following requirements of 21 CFR 111: o Subpart A – General Provisions o Subpart P – Records and Record Keeping o Subpart H – Master Manufacturing Records o Subpart I – Batch Production Record Module 2 of this course covers the following requirements of 21 CFR 111: o Subpart B – Personnel o Subpart C – Plants and Grounds o Subpart D – Equipment and Utensils Module 3 of this course covers the following requirements of 21 CFR 111: o Subpart E – Production and Process Control o Subpart K – Manufacturing Process Control o Subpart F – Quality Control o Subpart J – Laboratory Operations Module 4 of this course covers the following requirements of 21 CFR 111: o Subpart G – Components, Packaging, and Label Control o Subpart L – Packaging and Labeling Control System o Subpart M – Holding and Distributing o Subpart N – Returns o Subpart O – Complaints o The Role of the FDA and its Authority Read More

This module provides specific guidance on protecting dietary supplement products from contamination and adulteration during the manufacturing process.  It identifies the most common sources of contamination and how to prevent.  This module covers the following subparts of 21 CFR 111 with insights on how to design your quality program, facility and equipment to assure that finished product specifications are met: o Subpart B – Personnel o Subpart C – Plants and Grounds o Subpart D – Equipment and Utensils Read More

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