Genentech GMP Case Study Nine Behaviors That Lead to An Audit-Ready Facility

Held Jan. 21, 2010

Genentech’s Oceanside, Calif. manufacturing plant is a standout. Recently it won a coveted “Class A” certification from Oliver Wight International. By contrast, other drug and biologics manufacturing facilities receive ongoing warning letters that point to poor quality controls and insufficient manufacturing processes.

It may come as a surprise to discover that Genentech’s success comes down to 9 “Class A” behaviors — simple, practical formulas that you too can implement.

On Jan. 21, Edwin Fleischer, the quality expert who managed the creation of Genentech’s “9 Behaviors” formula, will share his strategies by presenting a case study on how his Oceanside facility captured the “Class A” certification.
If quality is your job, this seminar is your key to audit-readiness in your facilities. In just 90 minutes, you’ll get an inside look at the innovative processes and procedures that helped Genentech gain a competitive advantage with higher-quality manufacturing — and lower costs.

Each of the “9 Behaviors” contributes a piece to solving the GMP puzzle:

  1. Use one set of numbers
  2. Leave no one out of the loop
  3. Develop a passion for simplification
  4. Be democratic in planning but autocratic in execution
  5. Be confident in quality standards but remain open to innovation
  6. Develop a passion for accuracy — getting the best results every time
  7. Clarify roles and responsibilities
  8. Embrace accountability — get employees to speak up
  9. Continually measure manufacturing process performance

This webinar is totally interactive, with the opportunity to email all your questions for answers by the time the session ends.

Sign up every colleague who has a hand in quality, GMP, risk management, inspections and compliance. There’s just one low registration fee per facility, regardless of how many people participate.

You could spend a day ... a week ... a month ... or many months trying to develop the protocols Mr. Fleischer’s team has devised. Why not allocate 90 precious minutes to learn this hard-won knowledge for yourself?

  • QA/QC staff
  • Operations
  • Manufacturing
  • Plant engineering
  • Compliance officers
  • Training managers and coordinators
  • Regulatory/legislative affairs professionals
  • Executive management

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Edwin Fleischer, Director of Quality Control at Genentech’s Class A-certified Oceanside commercial manufacturing plant, specializes in leading quality improvement, operational excellence and compliance initiatives in biotech manufacture. He has comprehensive knowledge and experience in biotechnology, quality systems and government regulation — domestic and international — and has had numerous interactions with the FDA, the EMEA and other regulatory bodies.

Order now!