The 2010 FDA warning letters: Revealing the critical conduct areas in clinical studies

Instructor: Leonidas Lambrinidis
Product ID: 702073
  • Duration: 90 Min

recorded version

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Last Recorded Date: Nov-2011

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Read Frequently Asked Questions

This 90-minute webinar will review FDA warning letters in Clinical Trials and present critical parameters to watch out for in order to secure compliance whether you are running or monitoring a clinical trial.

Course "The 2010 FDA warning letters: Revealing the critical conduct areas in clinical studies" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

Whether you are a monitor or an investigator, word of an FDA inspection at your site is enough to make you wonder if everything has been done in compliance with the GCP guidelines.

This presentation will provide a cumulative review of the FDA warning letters of 2010 and help you identify the key conduct areas in clinical trials. When clustered, the findings that most frequently appear in warning letters are a measure of the severity of non compliance. We will show critical parameters to watch out for in order to secure compliance whether you are running or monitoring a clinical trial.

By attending this webinar, you can identify and take control of areas that are usually prone to non-compliance and apply early, preventive action to secure your site or your study.

Areas Covered in the Seminar:

  • Official definition of GCP and its importance.
  • Statistics: Frequency of appearance of deficiencies in the FDA warning letters of 2010.
  • What the statistics of warning letters reveal as critical conduct areas.
  • Common ranking of findings: minor-major-critical.
  • Overview of the key conduct areas.
  • Cases, analysis of deficiencies and CAPAs.
  • ICH guidelines on the Informed consent process.
  • Management of investigational drug.
  • Investigator site file and essential documents.
  • Source data capture in clinical trials.
  • Site and people management.
  • Importance of correct Authority submissions & approvals.
  • Achieving Protocol adherence.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in: Research Facilities, Clinics,  Pharmaceutical & Biotechnology industry and CROs conducting Clinical Trials including:

  • Investigators, site coordinators and subinvestigators
  • Clinical Research Associates
  • Clinical Operations Staff
  • Managers in Clinical Development and Project Leaders
  • Regulatory Compliance Associates and Managers
  • Quality Assurance Managers and auditors

Instructor Profile:

Leonidas Lambrinidis , BSc Biochemistry, MSc Biochemical Engineering, MBA, has 10 years of experience in clinical research. He has held various positions in the industry from CRA to Associate director of project management. He has worked both in the Pharmaceutical industry and CROs. Leonidas is experienced in sponsor, FDA and EMA inspections. He has also conducted both internal and external trainings.

Topic Background:

“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.”

Most countries have passed laws to ensure adherence with this standard and have founded organizations that inspect compliance. The US FDA inspects investigators, institutions, ethics committees and sponsors for adherence to GCP and federal regulations and has enough authority to take action when serious non compliance or fraud is strongly suspected or proven. One of the actions taken is to issue warning letters which appear in the public domain. Absence of corrective action or repeated misconduct may lead to further legal action and disqualification.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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