FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection

Instructor: Nicole Tesar
Product ID: 704640
  • Duration: 60 Min
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This 60-minute training program is designed for those working in the field of clinical research either as a sponsor (pharmaceutical/biotech company) or a research site. The session will discuss key FDA inspection terminology, types of BIMO inspections, site inspection procedures, and sponsor inspection procedures. Attendees will understand when an inspection is likely to be scheduled and the current trends in findings.

Why Should You Attend:

Are you ready for a FDA inspection? This course will provide sponsors and research sites with concrete steps to take in order to prepare for a BIMO (biomedical research) inspection. Attendees will learn what increases the risk of inspection, what types of inspections are conducted by BIMO, how to successfully prepare your site/facility and personnel, and how to interact with the FDA inspector. An overview of the Compliance Program Guidance Manual for Investigational Sites and Sponsors will be reviewed, as well as the BIMO site audit checklist.

Areas Covered in the Webinar:

  • When an inspection is likely to be scheduled
  • What types of BIMO inspections can be conducted
  • Become familiar with key FDA inspection terminology
  • What the FDA inspector will ask to see and current trends in findings
  • Site inspection procedures
  • Sponsor inspection procedures
  • Learn how to Identify key personnel and why it is important to have SMEs (subject matter experts)
  • Strategies for successful interactions with an FDA inspector

Who Will Benefit:

  • Regulatory Affairs
  • Regulatory Coordinator
  • Clinical Research Coordinator
  • Principal Investigator
  • QA/QC Staff

Instructor Profile:

Nicole Tesar is owner and director of clinical operations at Harmony Clinical Consulting Corporation. She began her career in clinical research over 18 years ago as a clinical research associate for a small contract research organization. The unplanned career that began after receiving her undergraduate degree has proven to be rewarding, challenging and continues to inspire her to do more and learn more in the field of clinical research.

Ms. Tesar has held roles such as CRA, lead CRA, project manager, regional operations manager, and auditor. In 2013 she started Harmony Clinical Consulting, providing consulting services to the pharmaceutical and biotech industries. She has experienced working for “Big Pharma” as well as small biotech companies. Her focus is in oncology, rare disease and orphan drugs. She has had the opportunity of being a contributor in the development of the following products: Myleran® (Busulfan) for Pediatric BMT, Herceptin® (Trastuzumab) for Metastatic Breast Cancer, TYKERB® (Lapatinib) for Breast Cancer and MYALEPT® (metreleptin) for Lipodystrophy. Ms. Tesar is currently working as an independent consultant for Acerta Pharma BV in collaboration with The Ohio State University on a second generation BTK inhibitor to treat chronic lymphocytic leukemia.

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