This week FDA posted one letter to a fertility clinic, two to drug manufacturers, and one to a compounding pharmacy, and we cover those here.
Former FDA Official David Doleski on Agency Hot Button Issues and Developing a Positive Relationship
After nearly 28 years at FDA—in review, inspection, and compliance positions—David Doleski, now Compliance Head for Biologics Quality Operations at Sanofi, provided his perspectives into how regulators think during his keynote presentation at the ISPE Aseptic Conference in early March 2020.
Join Lead Quality Systems and Compliance Consultant Steven Niedelman for a comprehensive webinar on what to expect during an inspection as well as the “Do’s and Don’ts” during an inspection.
Avoiding and Reacting to Human Tissue, Cell and Gene Therapy Enforcement Actions: Communication is Key
“The beauty of the TRIP program,” Laney said, “is that it is informal and non-binding. It is an open forum for tissue manufacturers and processors to talk to the agency and get advice in a way that fuels open communication on a rapid-response timeline.”
Join Technical Operations Manager Ernest Blanchard for a comprehensive webinar about the concept of risk management and risk-based thinking within management systems for GxP professionals.
Among the warning letters we follow, this week FDA posted one to a drug manufacturer, two to device firms, and one to a clinical investigator conducting studies on a device.