myCPE

Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA 1.5 Credits 1.5 Credits

May 27, 2022, 10:00 AM ET

Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA 1.5 Credits 1.5 Credits

  • Rating

    5

  • Published on

    December, 1969

  • Subject Area

    Information Technology

Learning mode

Live Webinar
  • Access the course at your convenience
  • Take the assessment test
  • Get your certificate
  • Attend the live interactive session
  • Answer the polling questions
  • Get your certificate
May 27, 2022, 10:00 AM ET

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 Overview

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.

On Demand Credits for All Qualifications

Live Webinar Credits for All Qualifications

License details Credits Status
Information Technology for Certified Public Accountants (CPA-US) 1.5 CPE Approved
Certified Information Technology Professionals (CITP) 1.5 CPD Eligible
Certified Information Systems Auditor (CISA) 1.5 CPE Eligible
Certified Information Security Manager (CISM) 1.5 CPE Eligible
Certified in Risk and Information System Control (CRISC) 1.5 CPE Eligible
Certified Wealth Strategist (CWS) 1.5 CE Eligible
Certified Fiduciary and Investment Risk Specialist (CFIRS) 1.5 CE Eligible
License details Credits Status
Information Technology for Certified Public Accountants (CPA-US) 1.5 CPE Approved
Certified Information Technology Professionals (CITP) 1.5 CPD Eligible
Certified Information Systems Auditor (CISA) 1.5 CPE Eligible
Certified Information Security Manager (CISM) 1.5 CPE Eligible
Certified in Risk and Information System Control (CRISC) 1.5 CPE Eligible
Certified Wealth Strategist (CWS) 1.5 CE Eligible
Certified Fiduciary and Investment Risk Specialist (CFIRS) 1.5 CE Eligible

Additional Information

Credits

1.5

Course Level

Basic

Instructional Method

QAS Self Study

Group Internet Based

Pre-requisites

None

Advance Preparation

None

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.

About Instructor

Carolyn Troiano

Carolyn Troiano

Account Executive, BrainStorm Central Consulting LLC

  • 4.5
  • rating
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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.

On Demand FAQs

What is Self Study (QAS)?

Self Study QAS (Quality Assurance Service) is a NASBA and other regulatory bodies approved program designed for Professionals to complete their Continuing Professional Education credits through self-paced, interactive courses that meet the highest standards of quality and compliance. We are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies.

How do I earn CPE credits through self-study?

To earn CPE credits, you must complete the self-study course, pass the required assessments, and submit the necessary documentation. Credits are awarded based on the completion of course hours and successfully passing the assessments.

Are the self-study courses approved by NASBA and other regulatory bodies?

Yes, all our self-study courses are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies, ensuring they meet the rigorous standards for quality and educational content set by these organizations.

What are the requirements to maintain compliance with self-study courses?

To maintain compliance, you must follow the guidelines set by NASBA and other regulatory bodies, which include completing the course within the specified timeframe, passing the assessments, and keeping accurate records of your learning activities.

How can I access my course completion certificates?

After successfully completing a self-study course and passing the assessments, you can access and download your course completion certificates from your account dashboard on our platform. These certificates are recognized by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies for compliance and reporting purposes.

How are credits reported to governing bodies?

We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days – the fastest in the industry.

Live Webinar FAQs

What is a Live Webinar Group Internet-Based Credit?

A Live Webinar Group Internet-Based Credit is an interactive, real-time online seminar where professionals can earn Continuing Education credits by participating in live sessions led by experts in various fields. These sessions meet the standards set by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies.

How do I earn credits through live webinars?

To earn credits, you must attend the entire live webinar, actively participate in any polls or questions, and complete any required evaluations or assessments. Credits are awarded based on your attendance and participation in the live session.

Are the live webinars approved by NASBA and other regulatory bodies?

Yes, all our live webinars are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies, ensuring they meet the high standards for quality, interactivity, and educational content set by these organizations.

What are the requirements to maintain compliance with live webinar courses?

To maintain compliance, you must adhere to the guidelines set by NASBA and other regulatory bodies, which include attending the full duration of the webinar, participating in interactive elements, and completing any post-webinar evaluations or assessments.

How can I access my webinar completion certificates?

After successfully attending a live webinar and fulfilling all participation requirements, you can access and download your completion certificates from your account dashboard on our platform. These certificates are recognized by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies for compliance and reporting purposes.

How are credits reported to governing bodies?

We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days – the fastest in the industry.

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