We’ve all heard the basic “How to Prepare for an Inspection” presentation. And we’ve heard your cries of “more detailed presentations, more specifics” on how to manage inspections.
Too often, firms slap together what is essentially the central nervous system of their inspections. There’s no forethought into the who, what, where, why and how behind every good inspection is a good war room.
Recently, during a drug company inspection, a heated argument broke out — in front of an FDA inspector — between two employees who disagreed on their own company procedures. Don’t let this happen to you.
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Dr. Darshan Kulkarni is the principal attorney at the Kulkarni Law Firm. He focuses on strategic regulatory and pharmaceutical counseling and has extensive experience handling the needs of international pharmaceutical, biopharmaceutical, and medical device companies and their service providers, including contract manufacturing organizations and contract research organizations. As corporate counsel for a reputable, international pharmaceutical holding company, Darshan provided corporate and regulatory legal advice to international pharmaceutical, biotech, and medical device companies. He has had experience in corporate quality control and has worked in varying legal and regulatory areas, including crafting responses to FDA 483s, FDA recalls, and negotiating with and for CROs and sponsors. Dr. Kulkarni has worked as a pharmacist for more than 10 years in multiple capacities, including hospitals, retail pharmacies, managed care, and has even participated as a clinician in clinical trials.
Participants include everyone who is a key player in hosting FDA inspections, including: