Pearls of Wisdom
What to Do During Those “Oh No” Moments: You’ve Just Received a Warning Letter from the FDA
In previous entries on the Pearl Pathways blog, I have discussed what to do when you are asked questions by regulators, when FDA inspectors show up at your facility, and when you receive an FDA Form 483. This time, I will address what to do when you get a...
The Ins and Outs of Drug Development – Mark Slisz will speak at Fred Hutchinson Cancer Research Center
Mark Slisz, a Senior Advisor at Pearl Pathways, will discuss why startups and independent researchers should approach the drug development process with a regulatory mindset months before their first formal interaction with FDA or other global health...
What to Do During Those “Oh No” Moments: You’ve Just Been Handed an FDA 483
What is a 483? It is an FDA form used by inspectors to list the non-compliant items that they found during the course of a facility inspection. In the previous entry in this series, we discussed what to do when the inspectors arrive. Now, let’s discuss...
What to Do During Those “Oh No” Moments: The Inspectors are Here
The previous entry in this series addressed that moment of panic you may feel when suddenly facing questions from regulators. This time, let’s talk about what to do when inspectors from a regulatory agency show up at your facility. Future topics will look...
Experienced Regulatory and Quality leader joins Pearl Pathways
Pearl Pathways announces the hiring of Eric English as a Quality Assurance and Regulatory Affairs (QA/RA) Advisor. Eric brings over 18 years of experience in quality, regulatory, and auditing roles within the pharmaceutical and medical device industries,...