Monday, 4 June 2012, 11.00 - 12.15
Moderator: Steven Lynn, Office Director (acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER, FDA
It’s a fact that antiquated, run-down facilities have a difficult time producing high-quality/fit-for-use products. Like any process, the manufacturing facility has its own lifecycle. If the facility is not reliable, the process will not be well supported and unexpected variation will be introduced. A manufacturer has the responsibility to take good care of their facilities, as well as the equipment and infrastructure inside the facility.
This session will emphasize why it is so important to continually reinvest in your facility throughout its lifecycle. A practical industry case study will be presented to illustrate the tangible business and quality benefits that lead to tangible bottom-line results that not only ensures that patients receive the product that they are relying on, but also the shareholders receive a return on their investment.
At the conclusion of this session participants will be able to:
11.00 – 12.15
Why It Pays to Continually Reinvest in Your Facilities & Systems
Session Moderator: Steven Lynn, Acting Director, Office of Manufacturing and Product Quality, OC, CDER, FDA
11.00 – 11.30
Quality is Free - Benefits of Keeping Facilities Current
Steven Lynn, Acting Director, Office of Manufacturing and Product Quality, OC, CDER, FDA
11.30 – 12.00
The Advantages of Proactive Facility Management