David Doleski Encourages Industry to Participate in FDA’s Emerging Technology Efforts; Sanofi Case Study Reviewed
After nearly 28 years at FDA, David Doleski, now Compliance Head for Biologics Quality Operations at Sanofi, provided his insight into the agency’s emerging technology efforts and the reason he feels strongly about industry participation.
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.
No warning letters to drug firms were posted this week. One warning letter was issued to a device firm and one untitled letter was issued to a stem cell firm.
Among the areas we cover, FDA posted one warning letter issued to a fertility clinic governed by the HCT/P regulations and one to a compounding pharmacy.
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.