This Webinar will discuss the importance of applying industry best practices when auditing a hardware, software, or other technology vendor, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
Computerized systems that are used in FDA-regulated environments (i.e., the system "touches" an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing or tracking processes) must be validated in accordance with FDA guidelines and documented accordingly. This course will describe the best practices for ensuring that any vendor hired to participate in development, implementation or maintenance of an FDA-regulated computerized system meets the existing government regulations, along with any policies, procedures and guidelines in effect at your organization.
We will discuss "who" should be responsible for such tasks and "how" the audit should be conducted. FDA guidelines are very specific in terms of how this is to be done, and a checklist will be provided to ensure that you meet them. 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.
Organizations generally rely on third-party vendors of computer hardware, software, operating systems, applications, network components, and other technical components. Many also rely on third-party vendors to provide configuration, development, implementation or other technical services. The degree to which these vendors meet FDA compliance must be at least as rigorous as that met by your organization.
Why Should you Attend:
You should attend this seminar if you are responsible for the development, implementation, or support of a system governed by FDA regulations that involves any third-party vendor, who either provides a technical component of the system or is hired by your organization as a consultant to provide technical services. FDA requires that you audit your vendors at least every two years, and that any findings are documented, along with the vendor's management response, which should include a specific set of remedial actions and a timeline for completing them.
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. By auditing the vendors involved, whether they are delivering products or services, you can be assured that their work will not compromise your system or any work done by your organization. Such work will also stand up during an FDA audit.
There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available for appropriately auditing your technical product and service vendors to ensure compliance.
Objectives of the Presentation:
Upon completion of this session, attendees will have an understanding of how to audit a provider of technical computer system components and/or services. You will understand how to scrutinize the vendor by using a checklist and set of questions to determine whether they comply with the FDA requirements and with your organization's policies, procedures and guidelines.
You will understand the process for reporting your findings to a vendor, eliciting their management response to your findings, and negotiating with them a plan for remediation that includes specific actions and target dates for completion.
This will help you implement and maintain your FDA-regulated systems in a way that ensures they are delivered and remain operating in a validated state, while minimizing your risk and costs. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program of vendor audit.
Who can Benefit:
Information technology analysts
QC/QA managers and analysts
Clinical data managers and scientists
Compliance managers, lab managers
Computer system validation specialists
GMP training specialists
Business stakeholders and individuals
Consultants working in the life sciences industry
Toll free: +1-510-857-5896
38868 Salmon Ter,
Fremont, CA 94536, USA
David Jonathan Moses
David Jonathan Moses