Creating, Staffing and Managing an Inspection War Room
Your First Line of Defense
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.
If you can’t confidently answer the following questions, order your CD/Transcript of this popular webinar.
- Who is going to be in your war room and how should you determine assigned roles and seniority?
- Who is responsible for guiding the FDA around a site? FDA investigators hate the “hordes” that follow them.
- What kinds of information should you provide — and what’s off limits to the FDA?
- What is considered privileged material or trade secrets and can you back your position up?
- If the FDA asks about the price of a product or what you pay for a good or service, are you going to respond?
- Photos within your facility? Yes or no? Either response has serious implications.
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:
- Senior Management
- Regulatory Affairs
- QA/QC
- Subject Matter Experts
- Inside and Outside Counsel
- Manufacturing Management/Supervision
- Laboratory Management/Supervision
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600