TRANSCRIPT

Description

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 validation activities are cost-effective while meeting all aspects of FDA compliance.

The webinar will focus on the importance of carefully managing the replacement of a legacy system that is validated in accordance with FDA requirements to preserve the integrity of data associated with it.  You will learn about the System Development Life Cycle (SDLC) methodology, which supports Computer System Validation (CSV) in compliance with FDA guidelines.  The key phases and deliverable throughout this process of replacing the system and preserving the data will be discussed.

Our expert speaker, Carolyn Troiano will talk about the importance of determining how to preserve data, whether through migration, conversion, archival, or some combination of these, depending on the data retention period.  She will also talk about bringing closure to the legacy system, whether through methodically planned system retirement or maintaining it offline during the period within which FDA may request access to data associated with it.

You will learn about the key challenges that are typically faced, and the best industry practices for overcoming these.  We will also discuss a strategic approach that includes good project management and organizational change management principles that can be applied to ensure the transition is smooth.

Learning Objectives:

At the end of this presentation, attendees will be able to learn:

  • Understanding of the C-TPAT program, compliance and benefits of joining the program
  • Industry best practices related to C-TPAT compliance
  • Develop a standard approach to complying with the voluntary C-TPAT guidelines.
  • Strategies for reducing the cost and complexity of compliance with C-TPAT

Area Covered In The Session:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • System Development Life Cycle (SDLC) Methodology
  • Validation Strategy that will take into account the system risk assessment process
  • FDA’s 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
  • Strategic Approach to ER/ES Compliance
  • Policies and Procedures to support GxP compliance
  • Training and Organizational Change Management best practices to help move the organization in a new direction
  • Industry best practices and common pitfalls

Target Audiences:

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Auditors
  • 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

About Our Speaker:

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.  She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, where she developed validation programs and strategies.  She collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.