Contact Us
Location: Building 535Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
Quality Management Program
Focused on Pharmaceutical and Biopharmaceutical cGMP Operations
Every company needs quality systems, even if they outsource some or all of their cGMP activities. Consequently, implementation and evaluation of quality systems, both internal and external, is a critical regulatory expectation of drug developers. This one-day course will provide valuable insights and educate the participants on how to draft and structure an effective quality management program. At KGI participants will (1) review and compare industry guidance from the FDA, ICH Q10, and cGMP requirements; (2) evaluate leading industry quality systems such as the Six-System Inspection Model; (3) discuss how to implement a pharmaceutical quality system utilizing risk assessment, gap analysis, and system/process reviews; and (4) engage in case studies and quality management review workshops.
Format: One day comprehensive and intensive training course, including group activites.
Business issues: During the last several years, the FDA has issued numerous observations and warning letters to pharmaceutical and biotechnology companies for not having adequate quality systems in place. The establishment of quality systems is thus an essential component of a company's overall cGMP operations.
Who should attend? Experienced life science executives with responsiblity for clinical and regulatory affairs. Seasoned project management professionals, research staff, and business development professionals will also benefit by the course.
Fee: $500/person, includes all materials and lunch.
Instructors:
Date & Location: Future dates to be announced