Integration of ERP and Legacy FDA-Regulated Systems - Recorded Webinar

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Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Carolyn (McKillop) Troiano Carolyn Troiano

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-wide 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.

Why should you Attend: Typically, any laboratory system in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process) must be validated 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.

Areas Covered in the Session:
- Gain an understanding of laboratory system computer validation planning, execution and management concepts, and how these efforts apply to any integrated business system
- Discuss the best practices necessary to develop an integrated laboratory and business data collection, analysis and reporting computer system validation program
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

Who Will Benefit:
- 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
- Any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance

Carolyn (McKillop) 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. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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.

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