Disaster Recovery Best Practices for an FDA-Regulated Environment
About This Event
Description:
This course is intended to provide specific guidelines for coaching attendees on the best practices for disaster recovery of systems and data, including the handling of documentation.
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.
Disaster recovery activities often include efforts to deal with both system functionality and data integrity, quality, accessibility and accuracy. The specific tasks and deliverables must be completed with care toward maintaining a compliant environment. There are best practices used in the FDA-regulated arena, and these can be leveraged to develop a standard and consistent approach within a company.
Why Should you Attend:
The attendee will learn how to develop a standard approach to planning, executing and documenting efforts that involve recovery of systems and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation, and will have to be coached on how to follow any necessary procedures required for compliance. This is often true for IT staff, and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. It's important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.
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 techniques and tools available to assure compliance when managing activities related to handling data.
Objectives of the Presentation:
The course will focus on the key aspects of disaster recovery efforts, including best practices and principles for handling this type of project work in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution of the product, or during any other functional activity). The material will include the various aspects of system and data related projects, and the result will be a prescriptive approach to helping teams and individuals reach a higher level of compliance.
FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how participants in projects should be managed.
Who can Benefit:
Information technology analysts, project managers, organizational change managers, business process engineers, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GxP training specialists, business stakeholders and individuals who are responsible for computer system validation planning, execution, testing, reporting, compliance, and audit. This webinar will also benefit any consultants, contractors or vendors providing products and services to the life sciences industries and who are involved in computer system implementation, validation and compliance.
About Company:
Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.
We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. Online Compliance Panel believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.
Contact:
Toll free: +1-510-857-5896
Email: [email protected]
OnlineCompliancePanel LLC,
38868 Salmon Ter,
Fremont, CA 94536, USA
Use For Registration:http://bit.ly/fdataken