Developing a Strategic Approach to FDA Compliance for Computer Systems

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries"

detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC)

Description

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, which is critical in order to be able to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.  It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.   We will discuss the phases within the SDLC, and how these form the basis for any CSV project that you may undertake, and the importance of the sequence of steps will also be covered, to ensure you are able to comply with FDA expectations.

Effective and compliant computer system validation is critical to any FDA-regulated organization.  During the past 30 years, best practices have been developed and, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.  This webinar will provide guidance for planning, executing and validating a laboratory computer system, and managing the system in a validated state through the end of the system life cycle.

The webinar will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.  We will cover the actual validation phases, deliverables and key points to ensuring the work is in accordance with FDA requirements for computer system validation, while also making sure the approach is cost effective for your organization.

The webinar will also address roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation.  You will learn what is required not only to validate your laboratory system, but maintain it in a validated state until it is retired or otherwise no longer in use.

There is an enormous body of documentation and information available on computer system validation, which 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 of methods, techniques and tools available.

Why Should You Attend

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.  This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.  We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.

Areas Covered

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.  This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.  We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered

Who will Benefit

Personnel in the following roles will benefit:

  • Information Technology Analysts
  • Information Technology Managers
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • 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 internal inspection

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

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

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