Best Practices for Auditing Computer System Vendors to Reduce Risk

Duration: 60 Minutes
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.
Auditing Computer System Vendor
Instructor: Carolyn Troiano
Product ID: 500445

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
  • Analytical chemists
  • Compliance managers, lab managers
  • Automation analysts
  • Computer system validation specialists
  • GMP training specialists
  • Business stakeholders and individuals
  • Consultants working in the life sciences industry
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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