Best Practices to Prepare for an FDA Computer System Audit

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Nov 22, 2017
60 minutes
Product Description

Complying with FDA’s Regulations on Computer System Validation and Audits

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

The FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. It’s not enough just to validate a computer system and defend your approach to regulatory agencies. Everyone from information technology analysts and clinical data scientists to compliance officers and auditors needs to ensure that the data and information collected, analyzed and reported using the system can be defended effectively.

Join this session with expert speaker Carolyn Troiano to learn all about preparing your system validation documentation for an FDA audit of your company’s computer systems. This session will help you learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner.

Session Objectives

  • 21 CFR Part 11 and what is required for compliance
  • Industry best practices related to compliance and computer system validation
  • Strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
  • How the System Development Life Cycle (SDLC) methodology supports the computer system validation process
  • How to effectively document the process of computer system validation,
  • How to maintain current information about the various systems in your organization and ensure they are maintained in a validated state
  • How to gain information about trends in validation, as industry progresses and new best practices emerge
  • Some of the industry best practices to apply when following the SDLC methodology

Session Highlights

  • Computer system validation (CSV) and the system development life cycle (SDLC) methodology
  • Good “variable” practice (GxP) (good manufacturing practice (GMP), good laboratory practice (GLP), and good clinical practice (GCP))
  • Validation strategy that will take into account the system risk assessment process
  • Functional requirements specification (FRS) to include the needs that are described in a specific and unique way
  • System design specification (SDS) that details how the functional requirements will be delivered
  • Test planning, including development of scenarios, cases and scripts (installation qualification, operational qualification and performance qualification)
  • Requirements traceability matrix (RTM) that connects the requirements, design and test elements
  • System acceptance and release notification
  • System retirement steps to close out the life cycle
  • Data archival to ensure security, integrity and compliance
  • Best practices for preparing for an FDA computer system audit
  • Q&A

Who Should Attend

This webinar will provide valuable assistance to all personnel in:

  • Information technology analysts
  • QC/QA managers
  • QC/QA analysts
  • Clinical data managers
  • Clinical data scientists
  • Analytical chemists
  • Compliance managers
  • Laboratory managers
  • Automation analysts
  • Computer system validation specialists
  • GMP training specialists
  • Business stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Carolyn Troiano - FDA Regulation Expert

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device 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.

Carolyn has spent a number of years evaluating supply chain security and compliance, including technologies...   More Info
More Events By The Speaker

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