Live Webinar Integration of Enterprise Requirements Planning (ERP) and Legacy Systems in an FDA-Regulated Environment

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Description

May 11, 2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

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.
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.

Why Should You Attend

You should attend this seminar if you are responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA 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 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

Areas Covered

•   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

Any FDA-regulated industry, plus any Life Science Consulting or Contracting firm

•   Information technology managers and analysts
•   Production managers and analysts
•   QC/QA managers and analysts
•   Clinical data managers and scientists
•   Compliance managers
•   Lab managers and staff
•   Automation analysts
•   Computer system validation specialists
•   GMP training specialists
•   Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
•   Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance

Industries who can attend

Professionals in the following industries may also benefit from the content:
•   Pharmaceutical
•   Medical Diagnostics
•   Biotechnology
•   Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
•   Animal Health


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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