ComplianceOnline

FDA Inspection Preparedness

Instructor: Susan Muhr Leister
Product ID: 704221
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

Why Should You Attend:

During this training session, attendees will expand their understanding of FDA inspections, the general purpose of the inspection, preparation strategies, and outcomes to assist clinical sites in preparing for an inspection with a culture of compliance. The course will discuss the BIMO inspection program, looking at FDA statistics and what one should expect during a clinical site inspection. Also, it will clarify key terms and responsibilities while refreshing clinical sites’ knowledge of the possible outcomes of an FDA inspection and how to respond to the FDA. This session will also review some helpful tips for inspection readiness.

Learning Objectives:

  • Discuss key terms and responsibilities related to FDA inspections
  • Discuss the purpose of the BIMO inspection program
  • Review the general purpose and overall process of an FDA inspection
  • Enhance your inspection preparation strategies
  • Understand how to respond to the FDA

Areas Covered in the Webinar:

  • Discuss key terms and responsibilities associated with an FDA inspection
  • Discuss the BIMO inspection program
  • Review the general purpose of an FDA inspection
  • Review preparation strategies
  • Discuss how to respond to the FDA following an inspection

Who Will Benefit:

  • Quality Assurance/Quality Control Managers
  • Directors
  • Auditors
  • Regulatory/Compliance Staff
  • Study Coordinators
  • Clinical Research Associates

Instructor Profile:

Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc. with over 19 years of experience in the pharmaceutical and medical device industry. She is also adjunct faculty for both graduate and undergraduate studies at the University of Phoenix. In addition to a bachelor’s degree in biochemistry and molecular biology, she has an MBA, a doctorate in organizational management with a focus on leadership, and holds certifications from the American Society of Quality (ASQ) as a Certified Quality Auditor and a Six Sigma Black Belt.

Dr. Leister has broad experience in GCP, GLP, and cGMP. She serves the ASQ Section 509 Executive Committee as the industry and professional development committee chair; she also served as a judge for ASQ’s International Team Excellence Awards in 2013 and 2014, and has been serving for the past four years as a Maryland Performance Excellence Award Examiner.

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