Quality and Regulatory Affairs

The role of quality in the pharmaceutical/biopharmaceutical industry continues to evolve to meet today's and tomorrow's needs and expectations. From regulatory compliance to an increased understanding to the role of the quality professional, TRI's courses in this area will provide you the foundation you need to meet the challenges posed by these growing needs and expectations.

Available Courses

2013 Aseptic Processing Training Program
    Session 1: February 11-15 and March 4-8, 2013
    Session 2: April 8-12 and May 6-10, 2013
    Session 3: June 3-7 and June 24-28, 2013
    Session 4: August 26-30 and September 23-27, 2013
    Session 5: October 14-18 and November 4-8, 2013

Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems (March 18-19, 2013)

From Cold Chain to Temperature Controlled Good Distribution Practices (GDP) (March 20-21,2013)

An Introduction to Visual Inspection - Session 1 (April 30 - May 1, 2013)

Active Temperature Control Systems: Qualification Guidance (June 13, 2013)

Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations (September 19, 2013)

CMC Regulatory Requirements in Drug Applications(September 19, 2013)

GMPs for Manufacturers of Sterile and/or Biotechnology Products (September 19, 2013)

Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances (September 20, 2013)

Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Manufacturing of Pharmaceutical Drug Products (September 20, 2013)

Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Packaging and Labeling of Drug Products (September 20, 2013)

An Introduction to Visual Inspection - Session 2 (October 9-10, 2013)

Investigating Microbial Data Deviations (October 24, 2013)