Clinical Trial auditing - Identifying risks and building a more compliant and successful trial


Instructor: Peter Calcott
Product ID: 701214

  • Duration: 90 Min
This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.
Last Recorded Date: Feb-2010


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

The field of GCP has rapidly evolved over the last 5 years and the requirements are getting tougher. Many companies find themselves unprepared for an FDA or EMEA inspection either at a clinical site or their headquarters. To prevent the surprises, early preparation is essential. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance. This will result in trials running smoothly, data being valid and giving your drug the best chance of success in the clinic leading to approval.

Areas Covered in the seminar:

  • What the major systems that must be in place - the requirements.
  • Ways to determine how well your systems are designed.
  • Ways to determine how well your systems are operating.
  • Major pitfalls that companies run into.
  • If I use a CRO, how much oversight is enough.
  • How do I manage sites, do I have to audit them all?
  • How do I manage an ex USA site.
  • How can I get processes that everybody will follow.

Who will benefit:

This webinar will provide valuable assistance to all companies that conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. The employees who will benefit include:
  • QA GCP staff
  • Regulatory Affairs
  • Clinical Operations
  • Clinical Development
  • Project Managers
  • Drug Safety staff

Instructor Profile:
Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, Pharma and venture capital industry. It provides consulting services in supply chain development and management, quality systems development and implementation, clinical development and monitoring, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).




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