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Best Practices in Preparation for an FDA Computer System Audit

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

Course Description

Course Description

As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the computer system must be validated following FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

This CPE webinar will focus on the most important key areas, including security and data integrity.

Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

In preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps or issues. The FDA contact person(s) should be able to tell the story of how each system came into production in a validated state and how each system is maintained in that validated state with the data integrity assured.

It’s important to have the right resources and understanding of the process before any inspection.  Having the validation information available and key resources who can speak to various components of it is critical and should be arranged in advance.

With the help of this CPE webinar, you will learn some tips based on real FDA inspections.

Learning Objectives

  • To discuss the regulatory influences that lead to FDA’s current thinking at any given time.
  • To analyze how to best prepare for an FDA inspection or audit of a GxP computer system.
  • To analyze best practices and inspector expectations for computer system validation and software quality assurance (SQA) programs.
  • To explain the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver to be able to defend the decision to choose them.
  • To analyze the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle.
  • To inspect how to identify “GxP” Systems.
  • To discuss the Computer System Validation (CSV) approach based on FDA requirements.
  • To investigate the System Development Life Cycle (SDLC) approach to validation.
  • To analyze how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
  • To comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches.
  • To analyze how to maintain a system in a validated state through the system’s entire life cycle.
  • To discuss how to assure the integrity of data that supports GxP work.
  • To investigate the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state.

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Best Practices in Preparation for an FDA Computer System Audit.

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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Best Practices in Preparation for an FDA Computer System Audit

$15

1.5 Credits

Subject Area

Information Technology