This course provides insight relative to the application of the Quality System Inspection Technique (QSIT). This course was developed by one of the original authors and life-long practitioner of QSIT.  Help prepare yourself for an FDA inspection by familiarizing yourself with the same inspection approach used by FDA investigators.   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

On 02 February 2024 FDA announced in the Federal Register a final rule amending the device current good manufacturing practices (CGMPs) requirements codified within the Quality System Regulation, 21 CFR Part 820.  The amendment was undertaken to harmonize and modernize the regulation.  FDA is accomplishing this primarily by incorporating by reference the 2016 edition of ISO 13485 and part 3 of ISO 9000:2015. The amendment has resulted in the Quality Management System Regulation (QMSR). This training provides in-depth insight relative to the content and implementation of the new Quality Management System Regulation including: the purpose, scope and goals of the new regulation; the major provisions and changes associated with the new regulation; the effective date of the new regulation; a discussion of the term “incorporation by reference” (IBR); reference to guidance on the implementation of ISO 13485:2016 within a quality management system; rules for understanding which terms and definitions will be used; FDA’s policy for addressing changes to ancillary regulations, policies, etc. impacted by the new regulation; quality management system regulatory requirements beyond ISO 13485:2016; and, how changes to the CGMPs impact 21 CFR Part 4 Regulation of Combination Products. This training is essential to anyone involved in transitioning a quality management system to the requirements of the new Quality Management System Regulation; or anyone who works within an impacted quality management system.  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. 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 Australia’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Australia is utilizing MDSAP.   Read more