Day 1

Lecture 1: Introduction and Background
  • Introductions/Participants' Understanding/Participants' Objectives for the Course (Please come prepared to discuss)
  • Background
  • Industry Context
  • Key Concepts
Lecture 2: Quality Risk Management
  • Science Based Quality Risk Management
  • Quality Risk Management Process
  • Initial Risk Assessment
  • Implement & Verify Appropriate Controls
  • Review Risks & Monitor Controls
Lecture 3: Life Cycle Approach
  • Computerized Systems Life Cycle
  • Specification & Verification
  • Computerized System Validation Framework
Lecture 4: Life Cycle Phases
  • Concept
  • Project
  • Operation
  • Retirement 

Day 2

Lecture 5: GxP Compliance
  • Data Integrity
  • Security
  • Defining Electronic Records and Raw Data
Lecture 6: Risks & Implementation of Systems
  • Simple Systems (Analytical Balance, pH Meter, Electronic Pipette)
  • Medium Systems (LIMS/ELN)
  • Complex Systems (Robotics)
Lecture 7: Supplier Documentation & Services
  • System Development by the Supplier
  • Supplier Assessment
  • Supplier Good Practices
  • Leveraging Supplier Knowledge & Documentation 
Quiz: Jeopardy!!!!
  • GxP Compliant Laboratory Computerized Systems

About The Course:


Laboratory Computerized Systems and data management operations are increasing in variety, sophistication, and complexity in the GxP environment.

Widespread reliance on these systems, along with their potential impact on data integrity, and the trend towards cost efficiency within companies, means that companies need achieve GxP compliance of laboratory computerized systems- within a reasonable budget and timeline.

The wide diversity of these systems, coupled with their capability for networking, makes it impractical and inefficient to have a single approach to achieve GxP compliance for all systems.

For example, a High Performance Liquid Chromatography (HPLC) with a Photo Diode Array (PDA) detector is much more complex than a pH meter, and will require a correspondingly more detailed and complex implementation, control, and maintenance approach.

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

Poor management of laboratory computerized system acquisition, implementation, and operation may result in:

  1. Failing to meet process and user requirements
  2. Unacceptable cost or time overruns
  3. Risk of non-compliance
  4. Data Integrity issues
  5. On the other hand, there are major business benefits to both regulated organizations and suppliers, in delivering systems that defined and specified and are easier to support and maintain. Benefits include:
  6. Reduction of cost and time taken to achieve and maintain compliance
  7. Early defect identification and resolution leading to reduced impact on cost and schedule
  8. Cost effective operation and maintenance
  9. Effective change management and process for continual improvement
  10. Enabling of innovation and adoption of new technology
  11. Providing frameworks for user/supplier co-operation
  12. Assisting suppliers to produce required documentation
  13. Promotion of common, consistent, system life cycle, language and terminology
  14. Providing practical guidelines and examples
  15. Promoting pragmatic interpretation of regulations 


This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation by:
  • Examining the system life cycle and its applicability for most laboratory computerized systems
  • Identifying characteristics that distinguish various types of laboratory computerized systems
  • Developing a rationale for scaling activities and effort based upon risk, complexity, and novelty
  • Defining a strategy for supplier assessments, and the effective leveraging of supplier knowledge, experience, and documentation
  • Applying the GAMP 5 Quality Risk Management (QRM) approach
  • Defining necessary operational and maintenance activities
  • Recommending an approach to system retirement
  • Leveraging deliverables and activities for very similar or identical systems 

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing and Supply Chain Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
  • Business System/Application Testers in FDA-Regulated Functional Areas
  • This seminar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.
Read more