Violation...Deviation: Whatever you call them, you need a process to manage them

Instructor: Tina D Forrister
Product ID: 701125
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2009

Training CD / USB Drive

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Read Frequently Asked Questions

This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.


One of the most common inspection findings is a failure by the Investigator "…to conduct the studies or ensure they were conducted according to the investigational plans". Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.

Areas Covered in the seminar:

  • The Purpose of the Process.
  • Definitions: Deviation...Violation…?
  • Suggestions for Documentation and Communication.

Who will benefit:

This webinar will provide valuable information to biotech and pharmaceutical professionals who are responsible for developing overall operational procedures or are planning and starting-up new trials, including development of monitoring plans and tools. Employees who will benefit include:

  • Clinical Project Managers / Study Managers
  • Clinical Program Managers / Program Directors
  • Clinical Operations or Clinical Research Directors
  • Clinical Research Associates / Site Monitors
  • Quality Assurance / Clinical Quality Assurance
  • Regulatory Manager / Associates
  • Site Start-Up Specialists / Site Managers

Instructor Profile

Tina D. Forrister, is a Senior Associate of Training and Development at Halloran Consulting Group, a privately held firm whose vision is to conduct clinical trials with biotechnology, pharmaceutical and medical device development clients using smarter approaches to clinical trial management. With 12 years in the clinical research industry, Tina’s experience ranges from monitoring to clinical project and clinical program management. Within training and development, Tina has provided worldwide training on clinical research and clinical operations with a focus on clinical project management, monitoring, global clinical research standards, and best practices.

Follow us :
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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.

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