Risk based approach to GxP Compliant Laboratory Computerized Systems

SEMINAR AGENDA:

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:

About Faculty: CAROLYN TROIANO

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:

Failing to meet process and user requirements
Unacceptable cost or time overruns
Risk of non-compliance
Data Integrity issues
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:
Reduction of cost and time taken to achieve and maintain compliance
Early defect identification and resolution leading to reduced impact on cost and schedule
Cost effective operation and maintenance
Effective change management and process for continual improvement
Enabling of innovation and adoption of new technology
Providing frameworks for user/supplier co-operation
Assisting suppliers to produce required documentation
Promotion of common, consistent, system life cycle, language and terminology
Providing practical guidelines and examples
Promoting pragmatic interpretation of regulations

SEMINAR OBJECTIVES:

WHO SHOULD ATTEND:

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.