FDAnews Announces — Inspections — From the Routine to the Truly Bizarre: How to Deal with Challenging Situations Webinar, Nov. 30, 2016

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As manufacturers are well aware, even a routine FDA inspection can be problematic, challenging or truly bizarre. How should manufacturers respond to these situations?

Inspections — From the Routine to the Truly Bizarre:
How to Deal with Challenging Situations
**An FDAnews Webinar**
Nov. 30, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/inspectionsroutinetobizarre    

How should manufacturers respond to this situation?

It’s Dec. 26 — the day after Christmas — and an investigator arrives for an unannounced inspection and is upset because personnel aren’t available.

What if the investigator takes out his smart phone and begins taking pictures with no explanation?    

As manufacturers well know even a routine FDA inspection can be problematic, challenging and bizarre.

Join storyteller and expert regulatory compliance specialist Steve Niedelman of King & Spalding on Nov. 30 when he’ll discuss these and other real-life situations. Steve has participated in hundreds of FDA inspections involving both small and large manufacturers.

After attending this 90-minute webinar attendees will be able to:

  • Deal with the most challenging FDA inspectors and situations, including unannounced inspections during trying times
  • React positively to unanticipated actions by FDA inspectors
  • Realize the FDA inspections are all about being prepared for all eventualities — while remaining flexible to existential events such as the inspector suddenly taking pictures with his smartphone

Register today and be prepared to deal with challenging inspection situations.

Meet the Presenter:
Steve Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the FDA. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.

Who Will Benefit:

  •     Compliance officers
  •     Quality Managers
  •     Regulatory Affairs
  •     General/corporate counsel
  •     Executive management
  •     Quality assurance
  •     Risk management specialists
  •     Outside attorneys
  •     Regulatory/legislative affairs professionals
  •     Department supervisors/directors

Webinar Details:
Inspections — From the Routine to the Truly Bizarre:
How to Deal with Challenging Situations
**An FDAnews Webinar**
Nov. 30, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/inspectionsroutinetobizarre    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/inspectionsroutinetobizarre                            
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.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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