COMPLIANCE

COMPLIANCE COURSE OPTIONS

As of February 2, 2026, the FDA will begin to enforce Quality Management System Regulation (QMSR), which is an amended version of the Quality System Regulation (QSR). The QMSR incorporates ISO 13485 and certain parts of ISO 9000. QMSR will improve the quality, safety, and efficacy of medical devices and will also help the United States to better align with other international regulatory agencies

Learn why the Quality Management System Regulation (QMSR) is important, and how it supports your business and compliance drivers, with  focus on FDA 21 CFR Part 820 Quality System Regulation, and a comparison to the ISO standard 13485.

This course provides a breakdown of the current Good Manufacturing practices and covers the requirements in 21 CFR Part 210 & 211 for Manufacturing, Processing, Packing, and Holding of Drugs and Finished Pharmaceutical.

Gain a high-level understanding of the regulations for the Biologics industry, with a breakdown of the FDA requirements in 21 CFR parts 600, 601, and 610.  Understand general requirements, licensing, and biologics standards.

Understand the international standard for organizations involved in clinical trials or studies. Understand GCP, including the recent updates to the regulations in E6(R2), ICH E6(R1), how the regulation came to be, and why they are essential for your organization.

Learn Current Good Manufacturing Practice (cGMP) regulations and how they apply to Combination products from the Pharmaceutical, Medical Device and Biologic Industries.

Review the requirements for 21 CFR Part 11, Public Docket 92S-0251, open and closed systems, and electronic signatures. Know the importance in using good documentation practices as we transition to a more paperless society.

The PathWise ISO 13485 training for medical device manufacturing online course covers outlines key areas, including the emphasis on risk management and risk-based decision making.

Learn the changes with the EU MDD transitioning to the EU MDR. Understand the key updates and differences, and what you must do i your organization to remain compliant.