|Quantity Discounts||1 - 9999|
|1 - 9999|
|1 - 9999|
|1 - 9999|
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.
SPECIAL BONUS for Attendees
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?
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
For one low price you will get:
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:
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.
Significant tuition discounts are available for three or more sites from
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
Check your local time against the times above. (Washington, D.C. is representative of Eastern time.)
Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600
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