cGMPs From An Auditor's Perspective 10 Common Violations To Avoid

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How will your next FDA inspection go? What will the investigator look for in your operation? Get inside the FDA investigator’s head..

Everyone can count on death and taxes. If you manufacture drugs, devices, biologics or diagnostics, here’s another thing to count on: a visit from the FDA.

A re-energized FDA has been hiring and training hundreds of additional investigators. Now they are fanning out into the field. Next thing you know, one of them will be knocking on your door.

What are their marching orders? Where will these recent recruits start poking around first, looking for soft spots in your manufacturing operation?

Dr. Robert Schiff, a top auditing consultant, knows where.

He makes it his business to stay a step ahead of the FDA. A certified quality auditor and fellow of the Regulatory Affairs Professional Society, he’s the next best thing to being a “fly on the wall” inside FDA’s investigator training classes.

Now, Dr. Schiff has compiled a list of the 10 most common cGMP violations in every FDA-regulated company ... and how to remedy them before an eager-beaver investigator knocks on your door.

Mark your calendar for Wednesday, March 31, 2010, when Dr. Schiff makes an exclusive appearance on your desktop screen, courtesy of FDAnews. In a fast-paced 90-minute webinar, he’ll disclose problem areas and arm you in advance with eight strategies to make sure you get a clean report:

  • Strategy #1: Creating a strong foundation with comprehensive internal audits
  • Strategy #2: Conducting OOS investigations that leave no stone unturned
  • Strategy #3: Getting employees audit-ready, whenever the FDA comes knocking
  • Strategy #4: Reviewing recent serious compliance cases, to understand — and avoid — the mistakes others are making
  • Strategy #5: How — and when — to present the investigator with appropriate documents
  • Strategy #6: Preparing your facility for a preapproval inspection
  • Strategy #7: What FDA and other regulatory auditors are trained to look for in CAPA
  • Strategy #8: Clearing up confusion and avoiding pitfalls

Everyone in your organization with a role in cGMPs deserves to take part in this event — and they can do so, at a cost that won’t break your budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

Have questions? Simply submit them via email for answers by the time the session ends.

Consider the costs of flunking an examination … think of the weeks spent on remediation and lost staff time ... even manufacturing downtime is a possibility. Weigh those costs against the 90 minutes you’ll spend with Dr. Schiff. It could be the most important 90 minutes of the year.

  • Operations
  • Manufacturing
  • QA/QC staff
  • Compliance officers
  • Plant engineering
  • Training managers and coordinators
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
  • Executive management
  • Internal auditors
  • Third party auditors

Robert Schiff, Ph.D., is CEO of Schiff & Company, a regulatory affairs, compliance and clinical research organization he founded in 1982 following stints with companies including Warner-Lambert, Hoffmann-La Roche, J. T. Baker (Richardson-Vicks), the Hyland Division of Travenol Laboratories (Baxter), and as an assistant professor at Tufts University Schools of Medicine and Dental Medicine. A certified quality auditor and fellow of the Regulatory Affairs Professional Society, Dr. Schiff has authored more than 50 publications and holds several patents on medical products.

Register now!

Date: April 5–23, 2010
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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