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

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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 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?

In far too many drug and device firms, the SMEs who know the most about front-line operations usually know the least about inspections. They need special training on dealing with investigators – how they operate, what techniques they use, cues they look for during interviews, how they prepare for inspections, their mindsets and motivations.

Fortunately, help is at hand.

Register Today

SPECIAL BONUS for Attendees
Attendees will receive a template document with 10 key questions
that will help you assess your inspection readiness.

You’ve got the room, the copies of documents, 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?

In just 90-minutes, have your SMEs and team ready for game time. This webinar can help you turn your 2013 FDA inspection nightmare into a dream! 

Don’t have time to listen to the webinar? No problem, Inspectional Readiness is also available in PDF or print. You’ll learn how to train SMEs for Inspection Day through three case studies – based on actual investigations – that show how things operate in the real world.

ONE STOP TRAINING PRODUCT FOR YOUR SMEs
Get the Inspectional Readiness Bundle

  For one low price you will get:

  • Access to the 90-minute webinar
  • CD and Transcript of the webinar
  • Template with 10 key questions to help assess your readiness
  • PDF copy of the training report with real-world case studies

From process owners and engineers to quality, manufacturing, project, operations and validations managers, everyone on your team will benefit from taking part in this event. Best of all, everyone can attend at a cost that won’t break the budget.

Sign up for Inspectional Readiness: Are Your SMEs Prepared for a Successful FDA Visit? today. Please note; this webinar has been previously recorded and no questions will be taken during the presentation.

This webinar bundle offers hands-on guidance of value to executives and personnel for drug, device, biologics and diagnostic companies, including:

  • Compliance Personnel
  • Regulatory Affairs Professionals
  • QA/QC Personnel
  • Training Managers
  • Potential SMEs for Inspection
Register now

Julie Larsen is the Director of Inspection Readiness Services at BioTeknica, Inc. Ms. Larsen, a Certified Quality Manager, has more than 20 years of experience with quality assurance and compliance in manufacturing, division, and corporate roles in medical device and pharmaceutical industries (17 years of 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 more than ten years, Mr. Solomon was the Vice President of Divisional Quality and Compliance at Roche Diagnostic. He has more than 30 years of experience working as a quality manger. Prior to working at Roche, Mr. Solomon was an FDA investigator and supervisory investigator. 

Date: Tuesday, March 26, 2013
Location: Your office or conference room (no need to travel!)
Time: 1:30 p.m. – 3:00 p.m. EDT
  12:30 p.m. – 2:00 p.m. CDT
  11:30 a.m. – 1:00 p.m. MDT
  10:30 a.m. – 12:00 p.m. PDT
  5:30 p.m. – 7:00 p.m. GMT

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

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

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