2014 - GAMP 5 and its Application to Computer System Categorization and Validation

Instructor: Carolyn Troiano
Description:
We will discuss the importance of categorizing computerized systems used in the manufacture, testing and/or distribution of pharmaceutical, biological or medical device products in accordance with GAMP 5 standards. Classification of the system is key to determining the best strategy and requirements for validating the system and preparing the necessary supporting documentation.
Typically, any computer system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process) must be validated in accordance with FDA guidelines for computerized systems. GAMP 5 guidelines provide a structure for categorizing such systems that enables the system and data owner to define such system and thereby perform the necessary validation and documentation to meet all requirements by FDA.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. GAMP 5 provides further guidance to categorize systems and develop the most cost-effective and efficient approach to validating such systems and documenting the plan and results.
Why Should you Attend:
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. You should attend this seminar if you are responsible for planning, executing or managing a computer system that is governed by FDA regulations. A full understanding of how to categorize such a system is key to ensuring this process will be adequate. There is an enormous body of documentation and information available on the subject that can be overwhelming. This course will provide a condensed overview of the most critical methods, techniques and tools available for interpreting GAMP 5 and related guidelines for validation.
Objectives of the Presentation:
Upon completion of this session, attendees will have an understanding of how to categorize a computer system prior to validation. The validation plan will vary according to the system classification, and this course will enable the attendee to understand the level of validation and documentation necessary to meet FDA requirements without resulting in excessive effort and/or cost.
The attendee will have received the guidance on best practices necessary to develop an appropriate vaildation approach to systems included in the organization's overall validation program. They will understand the steps for validating systems based on categorization, along with the key documentation associated with maintaining these systems in a validated state, while minimizing costs. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for their organization.
Who can Benefit:
This webinar will benefit any Consultants working in the Life Sciences Industry who are involved in Computer System Implementation, Validation and Compliance.
Information Technology Analysts
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Compliance Managers
Lab Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders and Individuals who are responsible for Computer System Validation Planning, Execution, Reporting, Compliance and Audit.
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