FDA Warning Letter Citations of GCP Non-compliance - What Were the Case History Findings that Generated these Warning Letters

Duration: 90 Minutes
There is a wide range of guidance, standard documents and regulatory requirements for Good Clinical Practices. This course is intended for diverse personnel involved in clinical trial study activities who may be new to clinical studies and those from a non-clinical background. In addition it serves as a refresher for those who have been conducting clinical study activities for quite some time. It focuses on each key role and respective responsibilities, including who is responsible for which document and what specific activity. It will also provide you with:
FDA Warining Letter Citation
Instructor: Vanessa Lopez
Product ID: 500791
  • A list of the regulations, guidance documents, standards, forms, reports and records that apply to clinical studies.
  • When and why FDA inspections are performed.
  • Common deficiencies observed by FDA investigators during clinical investigator inspection, including sponsor's deficiencies.
  • GCP Warning Letters issued to clinical investigators, sponsors, and IRBs.
At the end of the session, this webinar will provide recommendations for conducting successful clinical studies.

Why Should you Attend:
A basic understanding of Good Clinical Practice is a pre-requisite for anyone carrying out, or involved in, clinical research and trials. In addition to the description provided for this webinar, you will have a better insight of common Clinical Investigator/Sponsor/IRB violations found during FDA inspections and recommendations in conducting a successful clinical study.

Objectives of the Presentation:
This presentation aims at covering areas including:
  • Regulations, standards, guidance documents, records and reports associated to GCP
  • Definitions
  • FDA's bioresearch monitoring program (BIMO)- responsibility and focus
  • Roles and responsibilities (who is responsible for which documents and activities)
  • Why are clinical investigator inspections conducted
  • When are clinical investigator inspections conducted
  • Record retention time
  • Common deficiencies observed By FDA Investigators during clinical investigator inspection, including sponsor deficiencies
  • GCP related warning letters (to: clinical investigator; sponsors; IRB)
Who can Benefit:
This webinar will be of value to:
  • Clinical Research Staff
  • Clinical Studies Nursing staff
  • Clinical Trial Investigators
  • CRAs/Monitors
  • Clinical Studies Sponsors
  • Clinical Operation Managers
  • Clinical Study Coordinators
  • Quality Assurance/Regulatory Compliance Managers
  • Regulatory Affairs Staff
  • CROs Support Staff
  • New Members of the Independent Ethics Committee (IEC)/ Institutional Review Board (IRB)
  • R&D staff
$288
Recorded Session for one participant
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Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Vanessa Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 20 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as others.
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