Dan Schell

1 week ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderDuring the past few months, I've interviewed four women (see hyperlinks at the end of the article) who have either been a former FDA investigator or been involved with many regulatory inspections. Additionally, last year I interviewed former FDA investigator Vin Cafiso about his " 20 Things Never to Say to an FDA Investigator" list, and I spoke with another former FDA inspector, Patrick Stone, about what to expect from an FDA inspection.

2 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderMost of the people I talk to about FDA inspections either used to be behind the badge or have seen a few dozen audits up close. Elisabeth George stopped counting after 250. She didn't just attend those inspections - she ran them. Not as a quality lead or as the person nervously defending CAPAs, but as the designated host responsible for orchestrating the whole production, often at Fortune 500 scale.

3 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderI've interviewed former FDA investigators before, and each time I come away equal parts entertained and alarmed. Talking to Kara Harrison was no exception. Her résumé spans grading orange juice at the USDA to becoming a sharp-eyed quality consultant after a decade with the FDA, and I knew this conversation would be another one of those "I learned something today" moments.

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderOver the past few weeks, I've been speaking with former FDA investigators to get their take on what clinical sites are doing right, what they're doing wrong, and what they absolutely must be ready for. One of my favorite conversations was with Tracey Harris, who spent eight years with the FDA conducting inspections across sponsors, IRBs, and clinical sites as part of the Bioresearch Monitoring (BIMO) program.

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderIt's not every day that a mock regulatory inspection reveals a closet full of mold-covered records fused together by water damage and crawling with spiders - but that's exactly what Sarah Moeller encountered during one of her more memorable site visits. Her reaction was decisive: iron out the pages to salvage what could be saved, locate digital backups, and prepare to disclose the issue transparently to regulators.