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

  • Accountant
  • CPA (CA)
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
  • CIA
  • CMA
  • CPA (US)
  • CA - ICAEW
  • ACCA
  • CRISC
  • FPAC
  • CA - Ireland
  • CA - Scotland
  • CPA - Ireland
  • CFIRS
  • CWS
  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Course Description

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.  

It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.  The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

The system must specify the exact meaning of the signature.  It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result.  

A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability.  These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets its responsibility for meeting it. 

As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.  New technologies will continue to emerge that will change the way companies do business.  

While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

In this Online CPE webinar, speaker Carolyn Troiano will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.

Click here to access Online CPE webinars on Computer Software and Applications | Information Technology |

Learning Objectives

  • To explain 21 CFR Part 11 and what is required for compliance
  • To discuss industry best practices related to compliance and computer system validation
  • To discuss the strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
  • To describe how the System Development Life Cycle (SDLC) methodology supports the computer system validation process

Recommended For

  • This Online CPE webinar is recommended for CPAs, CISA, CRISC, CITP, and all the titles of ISACA who are responsible for planning, executing, or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

Who Should Attend?

  • Auditors
  • Certified Fraud Examiner
  • Certified Information Technology Professionals
  • Certified Management Accountant (CMA)
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Cybersecurity Pros
  • Fraud Professionals
  • IT Managers
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
  • 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
  • 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
  • 1.5 CPD Credit of System and Organization Controls Reporting for Certified Information Technology Professionals (CITP)
  • 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 of Information Technology for Certified Internal Auditors (CIA)
  • 1.5 CRE Credit for Certified Corporate FP&A Professional (FPAC)
  • 1.5 CPD Credit of Information Technology for Chartered Professional Accountant (CPA Canada)
  • 1.5 CPE Credit of Information systems for Certified Management Accountants (CMA)
  • 1.5 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
  • 1.5 CE Credit for Certified Wealth Strategist (CWS)
  • 1.5 General Credit for Accountant/Bookeeper
  • 1.5 CPD Credit for CA - ICAEW
  • 1.5 CPD Credit for Chartered Certified Accountants (ACCA)
  • 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 :
    Group Internet Based
  • Pre-requisites :
    None
  • Advance Preparation :
    None

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

$15

1.5 Credits

Subject Area

Information Technology

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