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

  • Accountant
  • CPA (CA)
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
  • CIA
  • CMA
  • CPA (US)
  • CA - ICAEW
  • ACCA
  • FPAC
  • CA - Ireland
  • CA - Scotland
  • CPA - Ireland
  • CFIRS
  • CWS

Published: May, 2022

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Before starting this self study program, please go through the instructional document.

  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

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

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.

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 IT professionals who want to understand Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA.

Who Should Attend?

  • Certified Information Technology Professionals
  • Certified Management Accountant (CMA)
  • Certified Public Accountant (CPA)
  • Compliance Managers
  • Compliance Officers
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Information Reporting Officers
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 General Credit for Accountant/Bookkeeper/Tax Professionals
  • 1.5 CPD Credit of Information Technology for Chartered Professional Accountant (CPA Canada)
  • 1.5 CPE Credit of Information Technology for Certified Fraud Examiner (CFE)
  • 1.5 CPE Credit for Certified Government Financial Manager (CGFM)
  • 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
  • 1.5 CPD Credit for Certified Information Technology Professionals (CITP)
  • 1.5 CPE Credit of Information security for Certified Internal Auditors (CIA)
  • 1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
  • 1.5 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
  • 1.5 CE Credit for Certified Wealth Strategist (CWS)
  • 1.5 CPE Credit of Information systems for Certified Management Accountants (CMA)
  • 1.5 CPD Credit for CA - ICAEW
  • 1.5 CPD Credit for Chartered Certified Accountants (ACCA)
  • 1.5 CRE Credit of Information Technology (inc. Excel) for Certified Corporate FP&A Professional (FPAC)
  • 1.5 CPD Credit for Chartered Accountants - Ireland (CAI)
  • 1.5 CPD Credit for Chartered Accountants - Scotland
  • 1.5 CPD Credit for CPA - Ireland

Additional details

  • Course Level :
    Basic
  • Credits :
    1.5
  • Instructional Method :
    QAS Self Study
  • 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 through its website: www.NASBARegistry.org.

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.

About Company

BrainStorm Central Consulting LLC

BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.


"Our experience will lead you to us, your experience will keep you coming back..."


FDA Compliance Training Topics Offered:

• Developing a Strategic Approach to FDA Compliance for Computer Systems

• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

• Medical Device Industry Trends for Computer Systems Regulated by FDA

• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA

• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

• FDA Compliance and Mobile Applications

• Good Documentation Practices to Support FDA Computer System Validation

• In-Depth Computer System Testing of Computer Systems Regulated by FDA

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

• Data Integrity and Governance for Computer Systems Regulated by FDA

• Trends in FDA Compliance and Enforcement for Regulated Systems

• Best Practices in Preparation for an FDA Computer System Audit

• Functional System Requirements for Computer Systems Regulated by FDA

• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA

• C-TPAT Compliance for FDA-Regulated Industries

• Medical Device Cybersecurity and FDA Compliance

• 21st Century Cures Act and Medical Device Software Compliance

• Medical Device Software 62304 Compliance

• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems

• Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Faq

FAQs content

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