Select Page

Online Training for

COMPLIANCE

COMPLIANCE COURSE OPTIONS

Quality Systems Regulation (QSR) for Medical Device

Learn why the Quality System Regulation (QSR) 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.

LEARN MORE

Current Good Manufacturing Practices (cGMP) for Pharma

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

LEARN MORE

Good Documentation Practices (GDP)

This module addresses why and how to document to exceed regulatory expectations, and ensure your organization is consistent in documenting activities.

LEARN MORE

Biologics

Gain a high-level understanding of the regulations for the Biologics industry, with a breakdown of the FDA requirements in 21 CFR parts 600601, and 610.  Understand general requirements, licensing, and biologics standards.

LEARN MORE

Good Clinical Practices

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 MORE

Combination Products

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

LEARN MORE

 

Electronic Records and Signatures

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.

LEARN MORE

QUESTIONS ABOUT PATHWISE ON-DEMAND COMPLIANCE TRAINING? CONTACT US! 

CAPTCHA image

* These fields are required.