ComplianceOnline

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

$299.00
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

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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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.

Description

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.

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