Tuesday, 5 June 2012, 11.00 – 12.30
Moderator: Joe Famulare, Senior Director, Genentech, USA
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 – 12.30
Watching Your Process – Assuring Quality and Process Performance
Session Moderator: Joe Famulare, Senior Director, Genentech
11.00 – 11.40
Establishing and Maintaining a State of Control
Karthik Iyer, PhD, Consumer Safety Officer, DHHS/FDA/CDER/OC/OMPQ, FDA, USA
11.40 – 12.15
Understanding and Recognizing Process Variability or Drift- Tools that Can Identify and Control Your Process
Dora Kourti, PhD, Senior Technical Director, GlaxoSmithKline
12.15 - 12.30
Question & Answer Session