Medical Device Industry Trends for Computer Systems Regulated by FDA

Product Id : FDA160
Instructor : Carolyn Troiano
Oct 08, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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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.

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.

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.

Learning 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
  • GxP - Good Manufacturing, Laboratory and Clinical Practices
  • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
  • Medical Devices, including hardware and software
  • Data Archival to ensure security, integrity and compliance
  • Recent FDA commentary on medical devices
  • Recent FDA findings for companies in the medical device industry
  • Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
  • Focus on Real-World Data (RWD) and Real-World Evidence (RWE)
  • Post-Market Surveillance and Med Watch Reporting
  • Post-Market Surveillance and Med Watch Reporting
  • Q&A

Who Will Benefit:

  • QC/QA managers
  • QC/QA analysts
  • Clinical data managers/scientists
  • Analytical chemists
  • Compliance managers
  • Laboratory managers
  • Computer system validation specialists
  • GMP training specialists
  • Software Validation
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Business stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
Speaker Profile:

Carolyn Troiano has vast experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, in which she has worked as a consultant for over 30 years. She has provided services to many large pharmaceutical and tobacco companies throughout the US and Europe. As part of her services, she has helped develop and execute compliance strategies and programs.

Carolyn also has experience in supply chain security and compliance, which includes technologies and procedures for improving the protection of companies’ brand integrity. At present, she is active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI).

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