Integration of ERP and Legacy FDA-Regulated Systems

Why Should You Attend:

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 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.

The program will offer attendees guidance on best practices necessary to develop an integrated laboratory and business data collection, analysis and reporting computer system validation program. They will understand the steps for validating systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Finally, attendees will also gain a good grasp of how to leverage these practices across all systems by creating a standardized program.

Areas Covered in the Webinar:

• 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
• Q&A

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, quality control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Instructor Profile:

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, Ms. Troiano 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.

She has participated in industry conferences and 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.

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