FDAnews Announces — Inspectional Readiness: Are Your SMEs Prepared for a Successful FDA Visit? Webinar, June 12, 2014

Subject Matter Experts (SMEs) need training and rehearsing to fine-tune their FDA investigator playbook. With this Inspectional Readiness webinar attendees will get best practices and key points to ensure SMEs are on top of their game.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) June 03, 2014

Inspectional Readiness:
Are Your SMEs Prepared for a Successful FDA Visit?
**FDAnews Webinar**
June 12, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/SMEInspectionalReadiness

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.'

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

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

The day the phone rings, announcing "the date," the company has to already be prepared. That takes practice.

So, FDAnews is going to help attendees get ready, with this webinar. Attendees will get best practices and key points to ensure SMEs are on top of their game.

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

For example:

  •     Does the newly hired quality manager fully understand the 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 the SMEs aware of company policies regarding taking photographs, access to internal audit files or other proprietary resources?

This 90-minute webinar can help 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 the SMEs and team ready for game time.

Who Will Benefit:

  •     Compliance personnel
  •     Regulatory affairs professionals
  •     QA/QC personnel
  •     Potential SMEs for inspection

Meet the Instructors:
Julie Larsen, Principal/Director, Inspection Readiness Services for BioTeknica, has more than 20 years’ 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). 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.

Webinar Details:
Inspectional Readiness:
Are Your SMEs Prepared for a Successful FDA Visit?
**FDAnews Webinar**
June 12, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/SMEInspectionalReadiness

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/SMEInspectionalReadiness
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.