Clinically-Related 483's and Warning Letters: Getting through the Maze

Instructor: Janet Rose Rea
Product ID: 702125
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This webinar on Clinically-Related 483's and Warning Letters will show how you can manage clinical site FDA inspections, handle issues, understand and respond to observations ("483") and/or Warning Letters.

Course "Clinically-Related 483's and Warning Letters: Getting through the Maze" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

FDA inspections of clinical trial sites, sponsors and IRBs have yielded observations (reported on FDA Form 483, or “483’s) and Warning Letters. Understanding the fundamentals of the FDA Biomedical Research inspections is critical in order to ensure that any observations and any subsequent regulatory action are dealt with appropriately and completely.

By the end of this webinar, the participant will have an understanding of the context for clinical site FDA inspections and the issues that may arise. Effective handling of these issues during the inspection can reduce the risk of further regulatory action. Should observations (“483”) and/or a Warning Letter be issued, participants will have an enhanced understanding how and the timing required to respond, and how to avoid further regulatory action by the Agency.

Areas Covered in the Seminar:

  • Managing FDA inspections.
  • Understanding observations.
  • Providing a written response.
  • Responding to observations (“483”).
  • Responding to a Warning Letter.
  • Dealing with the ramifications.

Who Will Benefit:

This course is intended for anyone who works in the clinical trial field and is subject to FDA regulation, including:

  • Institutional Review Boards (IRB)
  • Clinical Trial Site Investigators and key staff (physicians, nurses, pharmacists, etc.)
  • Clinical /Medical Operations
  • Clinical Quality Assurance

Instructor Profile:

Ms. Janet Rose Rea, recently joined the faculty at the U of W, providing a current industry perspective in the BioMedical Regulatory Affairs, where she had been a frequent lecturer since 1999. She also has two consulting firms. Most recently, she held the position of Vice President, Regulatory Affairs and Quality at Poniard Pharmaceuticals (previously NeoRx), from 2008 – 2010 and AVI BioPharma from 2003 – 2008. She was also a corporate officer for both organizations.

Trained as a public health microbiologist at the University of Washington, Ms. Rea started her career with American Dade Division, American Hospital Supply Corporation in Miami Florida in the microbiology quality assurance group, applying microbiological techniques to improve aseptic processing and reducing product failure. Thereafter, she returned to Seattle, working for Genetic Systems, Immunex – where she played a key role in the approval of the company’s first product, LEUKINE®, MDS Panlabs, and Targeted Genetics. Her diverse experience transcends the product development continuum in a variety of therapeutic areas, especially oncology and rare genetic diseases.

She has been active in training and lecturing on a variety of compliance topics.

She is a member of two Editorial Advisory Boards, and has lectured extensively as well as published. She received a Bachelor of Science in Microbiology and was conferred a Master of Science of Public Health (MSPH) from the University of Washington, Seattle WA.

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