Clinical Trials Audit Proof Monitoring Programs

Instructor: Charles H Pierce
Product ID: 701664
Training Level: Intermediate
  • Duration: 90 Min
This clinical trial audit training will explain how to identify gaps and risks when preparing for regulatory inspections of sponsor monitoring programs by understanding the components of a clinical trial quality monitoring system.

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: May-2013

Training CD / USB Drive

$299.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Why Should You Attend:

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. In this Webinar the components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

Areas Covered in the Seminar:

  • Discuss Sponsor monitors program.
  • Identify components of a sponsor monitoring system: beyond SOPs.
  • Distinguish each component’s suggested elements.
  • Define adequate oversight of non-employee performers.
  • Identify other measures to ensure quality monitoring.
  • Evaluate gaps monitoring systems.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, and CROs Conducting Clinical Trials including:
  • Sponsor Senior Management
  • Project Managers
  • CRA Managers
  • QA/Compliance
  • CRAs

Instructor Profile:

Dr. Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce has served as an advisor to several clinical research organizations.

He is presently the Medical Director of the Metabolic and Atherosclerotic Research Center which is part of Medpace, Inc. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

Follow us :

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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading