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Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

  • CISA
  • CPA (US)
  • CISM
  • CRISC
  • CDPSE
  • ITCA
  • Course Description
  • Course Qualification
  • Presenter
  • Faq

Course Description

Course Description

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 Disaster Recovery and Business Continuity Planning should be carried out.

This is necessary to protect against the onslaught of threats and attacks, both from natural disasters and as a result of cyber-warfare.

In this CPE webinar, the attendee will learn how to develop a standard approach to planning, executing, and documenting efforts that involve the 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 CPE 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.

Learning Objectives

  • To gain an understanding of disaster recovery and business continuity planning.
  • To discuss the ability to apply FDA compliance requirements when developing a disaster recovery and business continuity plan.
  • To analyze the best practices for developing a disaster recovery and business continuity plan.
  • To discuss the best practices necessary to ensure all systems regulated by FDA are protected against disaster and are recoverable in the event disaster strikes.
  • To 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.
  • To inspect the importance of preparing documentation that is compliant with FDA requirements.
  • To analyze the importance of training, as part of preparation.

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

Who Should Attend?

  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 CPE Credit for Certified Data Privacy Solutions Engineer (CDPSE)
  • 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
  • 1.5 CPE Credit for Certified Information Security Manager (CISM)
  • 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
  • 1 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
  • 1.5 CPE Credit for Information Technology Certified Associate (ITCA)

Presenter

About Presenter

Carolyn Troiano

Account Executive BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.

Faq

FAQs content

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Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

$15

1.5 Credits

Subject Area

Information Technology