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

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

Reviewed

January, 2024

Carolyn Troiano

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.

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 Information technology 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.

Overview

computer system validation (CSV)

3 mins
DR planning

11 mins
Business continuity (BC)

34 mins
Business continuity phases

45 mins
BC readiness - Best practices

70 mins

Webinar Qualifies For

1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
1.5 General Credit of Information Technology for Accountant/Bookkeeper/Tax Professionals
1.5 CPE Credit of Information security for Certified Internal Auditors (CIA)
1.5 CPE Credit of Information Technology for Certified Fraud Examiner (CFE)
1.5 CPE Credit of Information systems for Certified Management Accountants (CMA)
1.5 CPE Credit of Disaster Recovery Plans (DRP) for Certified Information Systems Auditor (CISA)
1.5 CPE Credit of Information Technology for Certified Government Financial Manager (CGFM)
1.5 CPD Credit of Information Technology for Certified Information Technology Professionals (CITP)
1.5 CPE Credit for Certified Information Security Manager (CISM)
1.5 CE Credit of Information Technology (inc. Excel) for Certified FP&A Professional (FP&A)
1.5 CPE Credit of Information Technology for Iowa Licensed Public Accountant (IA-LPA)
1.5 CPE Credit of Information Technology for Maine Licensed Public Accountant (ME-LPA)
1.5 CPE Credit of Information Technology for Delaware Licensed Public Accountant (DE-LPA)

About Instructor

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.

Additional Information

Duration

1.5 Hours

Course Level

Basic

Instructional Method

QAS Self Study

Pre-requisites

None

Advance Preparation

None

FAQ’s

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NASBA APPROVED

MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478

MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.

Ratings and Review

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Donna Kempa, CFE, CISA, CPA (US)

very convenient

1.5 Credits

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Subject Area

Information Technology

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

Course Details

Learning Objectives

Course Description

Overview

Qualifies for

Webinar Qualifies For

Presenter Details

About Instructor

Carolyn Troiano

Other Details

Additional Information

1.5 Hours

Basic

QAS Self Study

None

None

FAQ’s

NASBA APPROVED

Ratings and Review

4.4

Donna Kempa, CFE, CISA, CPA (US)

Subject Area

Unlimited Access Plan

Inclusions

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