Inspections — From the Routine to the Truly Bizarre - Webinar CD/Transcript

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Inspections — From the Routine to the Truly Bizarre: How to Deal with Challenging Situations

As you are well aware, even a routine FDA inspection can be problematic — challenging — or truly bizarre.

What if the inspector calls one of your line operators untrained and is hiding something?

What if the investigative team arrives without one of its key members, but wants to begin the inspection immediately?

How do you respond to these situations?

Join storyteller and expert regulatory compliance specialist Steve Niedelman of King & Spalding as he discusses 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 session you 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, such as the stalking of one of your female employees
  • Realize the FDA inspections are all about being prepared for all eventualities — while remaining flexible to existential events such as your inspector suddenly taking pictures with his smartphone

Order today and be prepared to deal with the challenging inspection situations that an FDA inspector may throw your way.

  • 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

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.