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.
The first quarter of 2020 is behind us, and with it, a fresh batch of warning letters sent by the FDA to food and dietary supplement companies.
We’ve compiled a snapshot of all of the letters that posted from January through the end of March and organized them by category provided by the FDA for your convenience. In total, 22 warning letters were sent for various infractions, ranging from FSVP violations to Insanitary Conditions.
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.
A serious concern of many is the security of their supply chain based on its complexity and global nature. We look at the GMP audit program and some options that may be able to help mitigate risk in this area, as well as explain choices made that may be asked during the next health authority inspection.
On Friday, March 13, 2020 Covington & Burling hosted a Briefing Call titled “COVID-19: Evolving Considerations for the Life Sciences Industry” spearheaded by the firm’s Food, Drug and Device industry practice. The discussion was wide-ranging and made some important points. We cover these here.
On Wednesday, March 11, 2020, the World Health Organization declared the spread of the respiratory illnesses caused by the novel coronavirus a pandemic. Here’s how it’s impacting some pharma and device firms.