Aging Facilities: How to Prolong Their Life and Avoid Quality Problems

Submitted by Anonymous on Fri, 05/31/2019 - 18:30
The Biopharm Industry is no longer new and neither are its production facilities. As facilities age, quality and reliability problems arise. These issues will often lead to supply and regulatory problems which harm patients and decrease the market value of the firm.
Two industry veterans will present case studies from their experience showing how they have addressed these issues. We will compare and contrast how companies started, the resulting differences in culture and capabilities (which often persist over time), and present our ideas of how to avoid the worst possible outcomes (Consent Decree, loss of market exclusivity and loss of reputation with the FDA). In two of these cases we will show what was done when an established manufacturing facility is purchased and then brought up to cGMP and company standards. In two other cases we will show what happened when continuous improvement and regular investment was not part of the company strategy.
Attendees should expect to learn the due diligence to follow when acquiring a company's facilities that may not be up to standard, and what to do when you find yourself in charge of a facility that has fallen behind the cGMP standards.
Session type
Schedule
Name
Aging Facilities: How to Prolong Their Life and Avoid Quality Problems
Time
-
Session Presentations
Prolong the Life of Aging Facilities
Prolonging the Life of Aging Facilities

Prolonging the Life of Aging Facilities
External ID
NA19CEOCT1/SES407