Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerize

Venue: Online Training Webinar

Location: Wilmington, Delaware, United States

Event Date/Time: Feb 09, 2011 End Date/Time: Feb 09, 2011
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Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority.

By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable level of effort. However, these systems can get bogged down during implementation due to the need for excessive validation testing and documentation. This, in turn, can lead to lengthy and sometimes fatal delays for roll-out to production.

How can such systems be validated in an efficient manner and with a level of documentation commensurate with actual regulatory risks? The key is to plan for validation at the beginning of the project with a fundamental focus on the development of good user requirements. Such requirements can be utilized to determine the extent of validation and to target the testing effort on the critical, regulated functionalities of the PDMA system. The result is a validation effort that can be optimized from both a cost and time perspective.

This webinar will provide a methodology for developing quality requirements for PDMA systems and will examine the benefits of leveraging those requirements to plan and drive the validation effort.

Why should you attend: With the FDA announcing that it will be performing Part 11 audit this year and the FDA currently inspecting and issuing warning letters to companies that have violated PDMA requirements, it is important to understand what the requirements are and how to ensure compliance with them. Noncompliance can cost companies millions in fines.

* Understanding the purpose of validation
* Defining Good Requirements
* Prioritizing Records
* Applying the Regulatory Requirements of PDMA and Part 11
* Performing Risk Assessments
* Leveraging Requirements for Validation

Who Will Benefit:

* Quality and Compliance
* Computer System Validation personnel
* Sales and Marketing


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