Preventing Product Liability 2016 - Integration of ERP and Legacy FDA-Regulated Systems - By AtoZ Compliance

Key Take Away:
Best practices to develop an integrated laboratory and business data collection, analysis and reporting computer system validation program, along with key documentation to minimize costs.
Overview:
We will discuss the importance of applying industry best practices when planning, executing and validating the integration of a laboratory system (Laboratory Automation System (LAS), Laboratory Information Management System (LIMS), eNotebook, etc.) with a business system, such as an ERP or similar type of enterprise or supply-chain automation system. These are commonly integrated in manufacturing companies that use large-scale, enterprise resource planning solutions for automating the production, testing and distribution processes in pharmaceutical, biotechnology, medical device or other related FDA-governed industries, and rely on data from laboratory systems to feed information about product quality and/or release.
Typically, any FDA computer system validation environment (i.e., the system "touches" product during the manufacturing, testing or distribution process) must be in accordance with FDA guidelines for computerized systems. By integrating such a system with a business system, the business system must also comply with FDA's requirements for validating the laboratory system. Otherwise, the "clean" laboratory system would be tainted by the "dirty" business system.
In addition to validation considerations, security must also be evaluated. Any data that resides on the laboratory system that must be kept confidential or secured in some way must continue to be treated the same way once integrated with a business system. Those users accessing the business system must also not be able to enter or alter data directly into the laboratory system, unless it is clearly a requirement based on the process being followed. There should be a distinct segregation of duties, as well, meaning all best practices for ensuring that the person responsible for entering data is not the person responsible for reviewing and/or approving the data.
Why Should You Attend:
You should attend this webinar if you are responsible for planning, executing or managing the ERP integration of a business system with any laboratory system governed by FDA rules and regulations.
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 the cost of integrating a validated system with an Enterprise Resource Planning (ERP) or other enterprise-wide system will be minimized.
There is an enormous body of documentation and information available that can be overwhelming. This webinar 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.
Areas Covered In This Webinar:
Identify the key input and output points that will warrant greater scrutiny as the integrated system is tested and validated
Discuss the steps for validating systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs
Learn how to leverage these practices across all systems by creating a standardized program for integrating FDA-regulated and non-regulated systems
Understand the additional training that must be provided to business and IT staff involved in the integration process
Discuss the communications necessary to maintain all integrated systems in a validated state, as required, as any changes are made to subsystems or components
Learning Objectives:
Get an understanding of laboratory automation system computer validation planning, execution and management concepts
How they apply to any integrated business system
Guidance on best practices necessary to develop an integrated laboratory and business data collection, analysis and reporting computer system validation program
Understand the steps for validating systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs
Get a good grasp of how to leverage these practices across all systems by creating a standardized program
Who Will Benefit:
Information Technology Analysts
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Compliance Managers
Lab Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders
Consultants in the Life Sciences Industry
Speakers Profile:
Carolyn Troiano
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, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.