FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

  • Accountant
  • CISA
  • CPA/CITP
  • CPA (US)
  • CRISC
  • CFIRS
  • CWS
  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Course Description

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing, and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category, and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” products, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio, and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?

The FDA is embarking on a modernization program to update their technology and processes for working with industry to assure regulated products meet FDA compliance. There are numerous programs underway, including partnerships with other agencies and industries to move forward as technology continues to improve. The FDA plans to take advantage of these technologies, just as the industry is focused on the same goal. The key is making sure these are employed in a way that promotes public health, providing more improved FDA-regulated products with fewer negative side effects and issues. Plans will also enable FDA to work with the industry to move products to market faster, further improving public health.

In this CPE course, we will explore the best practices and strategic approaches for evaluating the current processes involved in assuring computer systems used in the conduct of FDA-regulated activities are modernized and streamlined.

Cloud computing, Software as a Service (SaaS), automated computer system testing, and mobile devices are just part of the mix we can expect to explode in the near term.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

This CPE webinar will focus on the efforts by FDA to modernize its technology infrastructure, and what this means to the industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

In this CPE course, we will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from traditional Computer System Validation (CSV), which is based on the System Development Life Cycle (SDLC) methodology.

FDA is stressing the importance of industry understanding what is required to comply and thinking critically about new ways to achieve that. We will cover automated testing and continuous validation as key components of the SQA approach.

Learning Objectives

  • To analyze how to identify “GxP” Systems.
  • To discuss FDA’s current program for modernization of technology, and how this will impact the industry
  • To discuss FDA’s Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
  • To discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
  • To analyze the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
  • To discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
  • To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures, including ways to improve efficiency and effectiveness
  • To explain how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner
  • To analyze how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
  • To discuss the importance of “GxP” documentation that complies with FDA requirements
  • To analyze the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
  • To explain the regulatory influences that lead to FDA’s current thinking at any given time
  • 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.

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand FDA’s Technology Modernization Action Plan (TMAP) and its Impact on Regulated Computer Systems and Data.

Who Should Attend?

  • Certified Information Technology Professionals
  • Compliance Managers
  • Compliance Officers
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • CPA in Business
  • Entrepreneurial Accountant
  • Entrepreneurial CPA
  • Information Reporting Officers
  • Sustainability Manager
  • 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 CPD Credit for Certified Information Technology Professionals (CITP)
  • 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 CPE Credit for Certified in Risk and Information System Control (CRISC)

Additional details

  • Course Level :
    Basic
  • Credits :
    1.5
  • Instructional Method :
    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 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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FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

PREMIUM

1.5 Credits

Subject Area

Information Technology

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