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

Instructor: Peter Calcott
Product ID: 701214
  • Duration: 90 Min

recorded version

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: Jul-2011

Training CD / USB Drive

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


Read Frequently Asked Questions

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.

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.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA

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 call +1-888-717-2436 (Toll Free).

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