Impact of Integration of Laboratory and Business Systems

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Deadline: May 22, 2014 | Date: May 22, 2014

Venue/Country: 38868 Salmon Ter, Fremont, U.S.A

Updated: 2014-05-06 19:29:44 (GMT+9)

Call For Papers - CFP

Description:

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.

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report 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 building and managing a computer system validation program 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.

Objectives of the Presentation:

Upon completion of this session, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system. They will have received the 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. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program.

Who can Benefit:

This webinar will benefit any Consultants working in the Life Sciences Industry who are involved in Computer System Implementation, Validation and Compliance.

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 and Individuals who are responsible for Computer System Validation Planning, Execution, Reporting, Compliance and Audit.

Register Now:

http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500313?expDate=Ourglocal