ComplianceOnline

Drug accountability in clinical trials - Is your site GCP compliant?

Instructor: Madhavi Diwanji
Product ID: 702071
  • Duration: 60 Min

recorded version

$299.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar on Drug accountability in clinical trials will provide understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.

Why Should You Attend:

The field of GCP has rapidly evolved over the last few years and the requirements are getting tougher. Many companies find themselves unprepared for a clinical trial audit, either at a clinical site or their headquarters. One of the important aspect of managing a clinical trial is drug accountability.

An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes. When drug accountability records are well designed and error-free, and appropriately reconcile from initial shipment to the site through final disposition, this statement should hold true.

This course will help you to prepare early and help to prevent surprises when being audited. Learn to efficiently manage drug accountability. This program will also share the ”audit experience”, by sharing what auditors look for in term of drug compliance and accountability and how to prepare for the visit. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance..

Areas Covered in the Seminar:

  • Investigational Drug Shipment.
  • Drug accountability at the investigative site.
  • Documentation in Key to accountability.
  • Ensuring Compliance and reconciliation.
  • Corrections.
  • Monitors.
  • Drug Return or destruction.
  • What auditors observe?
  • FDA inspection findings- Warning letters.

Who Will Benefit:

This webinar will provide valuable assistance to all companies/employees (research sites, Clinical research organization, pharmaceutical and biotech industries) that conduct clinical trials.

  • Clinical Trial staff and management
  • Clinical Research Associates
  • Clinical Research Coordinator
  • Research Pharmacists
  • Project Managers
  • Drug Safety staff

Instructor Profile:

Madhavi Diwanji, BS, MBA, CCRC is the President of MD Clinical Monitor.  She has tremendous experience in the healthcare industry in various roles for the past 20 years.  She is well rounded in all aspects of clinical trial as she has been instrumental in healthcare research with a primary focus on cardiology for 8 years. She has experience with monitoring clinical trials, conducting clinical trials, investigator initiated trials, maintaining multiple Trial Master Files, starting a research program in a hospital, health services research, regulatory /compliance submission and management, grant submission, business development and fundraising.  She has successfully worked with different IRBs, CROs and sponsors. She has served on a study coordinator advisory committee of a global Congestive Heart failure clinical trial.

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