ONLINE TRAINING 2016 - Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA - By AtoZ Compliance

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Category Computer system validation training, Business Continuity Plan training, fda training, fda compliance training , fda training requirements

Deadline: March 01, 2016 | Date: March 01, 2016

Venue/Country: New Hyde Park, U.S.A

Updated: 2016-02-05 19:19:40 (GMT+9)

Call For Papers - CFP

Learn the FDA best practices used in specific tasks and deliverables for both disaster recovery and business continuity to maintain care and to ensure a compliant environment.

Overview

Computer system validation training 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.

Business continuity plan training often include efforts to deal with system functionality and data integrity, quality, accessibility and accuracy, but the focus is on getting the business processes running in the absence of a sound system or data.

The specific tasks and deliverables for both disaster recovery and business continuity must be completed with care toward maintaining a compliant environment.

There are best practices used in the FDA training, 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 webinar 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.

Areas Covered In This Webinar

The webinar 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.

The webinar will include the various aspects of system and data related issues that force an organization to revert to backup operations, and the result will be a prescriptive approach to helping teams and individuals reach a higher level of compliance.

FDA compliance training 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.

Learning Objectives

Gain an understanding of disaster recovery and business continuity planning

Develop the ability to apply FDA training requirements when developing a disaster recovery and business continuity plan

Understand the best practices for developing a disaster recovery and business continuity plan

Discuss the best practices necessary to ensure all systems regulated by FDA are protected against disaster and are recoverable in the event disaster strikes

Discuss the best practices necessary to ensure all critical business operations can continue uninterrupted, should a disaster occur that causes key systems to become inoperable or inaccessible

Understand the importance of preparing documentation that is compliant with FDA requirements

Learn about the importance of training, as part of preparation

Who Will Benefit

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

Consultants in Life Sciences Industry

Speakers Profile

Carolyn Troiano

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, 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.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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