2014 - Reducing Risk through Computer Vendor Audits

Instructor: Carolyn Troiano
Description:
We will discuss the importance of applying industry best practices for reducing risk by conducting a thorough vendor audit of vendors producing hardware, software and other computerized components that are purchased and used by a company that is regulated by FDA. These systems and components must meet all requirements for computer system validation, as prescribed by FDA. As such, the vendor must assure that all of their processes for manufacturing and testing the systems and components will also meet FDA's criteria.
During the webinar, we will review several appoaches to evaluating the way in which a vendor produces, tests and distributes its various computer-related products. The vendor must follow as rigorous a set of processes as that of any FDA-regulated company. A thorough investigation of the vendor is required as a first-line of defense, and will minimize the risk of falling out of line with FDA requirements for computerized systems.
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. Knowing how a vendor achieves validation of a computer or component will enable a company to select the appropriate vendor to work with in order to reduce overall compliance risk.
Why Should you Attend:
You should attend this seminar if you are responsible for planning, executing or managing the implementation or support of any vendor-produced computerized system or component governed by FDA regulations.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized, and evaluating the practices applied by vendors that provide such systems and components will ultimately allow a company to reduce its overall risk, along with the cost of validation.
Objectives of the Presentation:
Upon completion of this session, attendees will have an understanding of how best to evaluate the processes and procedures of vendors providing computer systems and components that will be used in an FDA-regulated environment. They will have a better knowledge of how to go about such an investigation, including the key areas to review, methods that will reduce the time and cost of evaluation, and how the results can be applied to the company's computer system validation effort and overall program. They will understand the steps, along with the key documentation associated with auditing a vendor, while minimizing costs. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program.
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.
Register Now:
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Online Compliance Panel LLC
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