Inspectional Readiness Are Your SMEs Prepared for A Successful FDA Visit?

Held May 31, 2012

You have spoken — and we’re responding. By popular demand, FDAnews is releasing an Audio CD/Transcript of this best-selling event for drug and device manufacturers.

More than 200 people listened to this invaluable webinar when it was originally produced. Here’s what our satisfied registrants had to say:

“The case study discussions were very educational.”

“I liked having a presenter who is also an ex-FDA investigator.”

Athletes go over their plays until they become second nature. So, by the time they're facing their opponent on the field, it's 'show time.'

Your Subject Matter Experts (SMEs) need the same kind of training and rehearsing to fine-tune their FDA investigator playbook.

Sure, you have all the logistics nailed down.  But how well prepared is your team to interact with FDA investigators?

The day the phone rings, announcing "the date," you'll have to already BE prepared! That takes practice.

So, we're going to help you get ready, with this ONE-OF-A-KIND audio CD/transcript. You'll get best practices and key points to ensure your SMEs are on top of their game.

You’ve got the room, the copies, who’s going to meet the investigator, but are your SMEs prepared to answer the FDA inspector’s questions succinctly and confidently?

For example:

  • Does your newly hired quality manager fully understand your processes or quality records or might he or she be tripped up by a simple question?
  • What should an SME say to an FDA investigator if he or she just doesn’t know the answer to a question?
  • Are your SMEs aware of your company policies regarding taking photographs, access to internal audit files or other proprietary resources?

This one-of-a-kind 90-minute audio CD/transcript can help you turn an FDA inspection nightmare into a dream! 

The manner in which these inspections are handled can have a major impact on the results. The appropriate handling of inspections can affect the timing of approvals and may mean the difference in whether the agency takes a regulatory action or grants a product approval.

In just 90-minutes, have your SMEs and team ready for game time.

Meet Your Instructors

Julie Larsen is the Director Inspection Readiness Services at BioTeknica, Inc. Ms. Larsen, a Certified Quality Manager, has over 20 years of experience with quality assurance and compliance in manufacturing, division, and corporate roles in medical device and pharmaceutical industries (17 years leadership experience in Quality operations and compliance at Abbott). She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement as well as successfully addressing Consent Decree, Warning Letter and 483 responses.

Arnold Solomon is the President of FDA Strategic Compliances, LLC. For over ten years, Mr. Solomon was the Vice President Divisional Quality and Compliance at Roche Diagnostic. He has over 30 years of experience working as a quality manger. Prior to working at Roche, Mr. Solomon was a former FDA investigator and supervisory investigator.

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