This course bundle provides 6 eLearning courses, 16 hours of training in total, to prepare you and your team for FDA Medical Device Inspection.  Each course includes focused content developed by medical device experts experienced in conducting and managing FDA Inspections; knowledge checks throughout the course to keep the learner engaged; and a final competency assessment at the end of each course.  Individual Certificate of Successful Completion is provided for each of the 6 courses.  Courses in this bundle include: FDA Inspections of Medical Device Manufacturers FDA Medical Device Reporting Requirements  ISO 14971:2019 Application of Risk Management to Medical Devices Medical Device Complaint Handling and Servicing, Design Controls for Medical Devices and IVDs U.S. Quality Systems & Combination Products- Practical Instruction.  Read More

In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary. The Quality System Inspection Technique, QSIT, is the primary tool used to conduct FDA inspections of medical device manufacturers.  QSIT is publicly available and will be the primary focus of this module. Read More

The U.S. Medical Device Reporting regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers and device user facilities to report certain device-related adverse events and product problems to the FDA. This course provides critical information to ensure mandatory reporters maintain compliance with the regulation. 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