myCPE
myCPE

Trends in FDA Compliance and Enforcement for Regulated Systems 1.5 Credits

Apr 13, 2022, 10:00 AM ET

Trends in FDA Compliance and Enforcement for Regulated Systems 1.5 Credits

  • Rating

    4.6
  • Reviewed on

    January, 2024
  • Subject Area

    Information Technology

Select your learning mode

  • 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
Apr 13, 2022, 10:00 AM ET

Learning Objective

  • To discuss Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology.
  • To analyze the importance of doing a risk assessment of all FDA-regulated systems.
  • To discuss the importance of categorizing your FDA-regulated software according to GAMP 5 guidelines.
  • To inspect “GxP” Systems.
  • To discuss 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES).
  • To analyze how Data Archival plays a key role in ensuring security, integrity, and compliance.
  • To explain how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes.
  • To discuss recent FDA findings for companies in regulated industries, specifically related to computer systems, validation, 21 CFR Part 11, and data integrity.
  • To investigate the latest guidance from FDA on data integrity.
  • To analyze recent trends in technology that need to be addressed in the CSV approach.
  • To analyze industry best practices for becoming inspection-ready.

Course Overview

Computer system validation has been regulated by FDA for nearly 40 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.

In December 2018, FDA issued a guidance document on Data Integrity (DI), which has seen an alarming increase in DI issues during inspection of regulated firms. This upward trend continues and is of particular interest during FDA inspection.

In this CPE information technology webinar we will explore the best practices and strategic approaches for evaluating computer systems used in the conduct of FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process, and product quality, and consumer/patient safety.

We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

Whether you are taking a waterfall or agile approach to developing, testing, and supporting a regulated system, this CPE course will guide as on how to apply the GAMP®5 “V Model” to either one.

The waterfall or traditional CSV approach is very documentation-centric, while the agile approach, which aligns with FDA’s current thinking on Computer Software Assurance (CSA) is focused primarily on critical thinking. We will delve into the differences, the pros and cons, and the various mechanics involved in each of these. We will also discuss cloud services, Software as a Service (SaaS), and other types of technology for which the FDA has not yet offered guidance. Our approach to validating these types of systems is based on common sense and industry best practices.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance.  We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

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.

In this CPE webinar, we will focus on the most effective practices for meeting FDA compliance for Computer System Validation (CSV), as well as 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures, and Data Integrity (DI).

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. The CPE course includes information and advice for complying with FDA for 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. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.

Podcast Credits

Short Video Credits

On Demand Credits

Live Credits

Enter your qualification details to ensure this course is counted toward your compliance.

Add your qualification details to easily track your compliance. You can also add multiple qualifications for comprehensive coverage.

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

  • 4.4
  • rating
  • rating
  • rating
  • rating
  • rating

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.

Reviews and Ratings

out of 5

rating rating rating rating rating
1,824 ratings

Excellent

Very Good

Average

Poor

Terrible

Recommended Courses

Macro Magic: Advanced Techniques and Tips

Dec 16, 09:00 AM ET

  • CFE
  • CGFM
  • CPA (US)
  • FPAC
  • IA LPA
  • ME LPA
  • DE LPA
People & Profits: Do You Know What Time is Costing You?

Dec 16, 11:30 AM ET

  • CMA
  • CPA (US)
  • HRCI
  • SHRM
  • IA LPA
  • ME LPA
  • DE LPA
Excel Accountant: Database Techniques

Dec 16, 01:30 PM ET

  • CFE
  • CGFM
  • CPA (US)
  • FPAC
  • IA LPA
  • ME LPA
  • DE LPA
Take Control of Excel: Smart Solutions for Work Challenges- Part 1

Dec 16, 03:30 PM ET

  • CFE
  • CGFM
  • CPA (US)
  • FPAC
  • IA LPA
  • ME LPA
  • DE LPA
Tableau Beyond Basics: Advanced Data Analysis

Dec 16, 04:00 PM ET

  • CPA/CFF
  • CGFM
  • CPA/CITP
  • CMA
  • CPA (US)
  • CFA
  • CGMA
  • CIPM
  • FPAC
  • IA LPA
  • ME LPA
  • DE LPA
Introduction to Power Query in Excel

Dec 17, 09:00 AM ET

  • CFE
  • CGFM
  • CPA (US)
  • FPAC
  • IA LPA
  • ME LPA
  • DE LPA
Inclusions
  • Multiple Credits
    Multiple Credits

    Earn continuing education credits with flexibility. Choose from live webinars, on-demand courses, e-books, or podcasts to fit your learning style and schedule.

  • Certifications & Reporting
    Certifications & Reporting

    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 - fastest in the industry.

  • Credit Tracker
    Credit Tracker

    Track and manage your compliance across all 50 states and over 100 designations. Our Credit Tracker keeps your CPE credits and compliance requirements always up-to-date.

  • Certificate Vault
    Certificate Vault

    Certificate Vault to upload, manage, and access certificates earned from various sources and an integrated credit tracker, allowing users to monitor and manage their credits conveniently for compliance.

  • Compliance Reminders
    Compliance Reminders

    Stay current with our automated reminder system. Receive timely alerts for your CPE requirements, ensuring you never miss a deadline.

  • Mobile App Access
    Mobile App Access

    The myCPE Mobile App allows you to learn on the go, providing access to educational content on Android and Apple iOS devices. You can learn anytime and anywhere, making it convenient for busy schedules.

  • Live Support
    Live Support

    Our support team is available via live chat, email, and phone from 9 AM to 5 PM ET. We're here to help with any questions or issues, ensuring you have a seamless experience.

Exclusive mobile
app for our unlimited
access subscribers

Add qualification to
view credit details

This course is included with,

Individual Subscription

Gain access to everything required for compliance, skill enhancement, and staying ahead of industry trends—all included in the Individual subscription. Here’s what you get:

  • 13,000+ Hours of NASBA-Approved Content
  • 500+ Emerging Subject Areas
  • 50+ State- Specific Ethics Courses
  • 100+ Conferences with Access to Industry Events
  • 250+ FastTrack Compliance Packages

    Pre-selected courses for quick compliance

  • Exclusive Mobile App Access
  • Access to Professional Communities

    Connect with like-minded professionals on Teams.

Trusted by 250,000+ Professionals

trust pilot review google review
Unlimited Access

Ready to Get Started?

Sign up today and begin your learning journey immediately!

card
stripe
$299$199 For 12 Months
Subscribed
Xiaoyan purchased a subscription.
Subscribed
PAUL purchased a subscription.
Subscribed
Amanda purchased a subscription.
Subscribed
Steven purchased a subscription.
Subscribed
GAIL purchased a subscription.
Subscribed
Pam purchased a subscription.
Subscribed
Mei purchased a subscription.
Subscribed
David purchased a subscription.
Subscribed
Andrew Deneke purchased a subscription.
Subscribed
Karen purchased a subscription.
Subscribed
Cheryl purchased a subscription.
Subscribed
Kathie purchased a subscription.
Subscribed
Jacqueline purchased a subscription.
Subscribed
Debra purchased a subscription.
Subscribed
Nicole purchased a subscription.
Subscribed
Isabelle purchased a subscription.
Subscribed
Michael purchased a subscription.
Subscribed
Moiz purchased a subscription.
Subscribed
julianne purchased a subscription.
Subscribed
Jacqueline purchased a subscription.
Subscribed
Brandon purchased a subscription.
Subscribed
Candice purchased a subscription.
Subscribed
Tina purchased a subscription.
Subscribed
Scott purchased a subscription.
Subscribed
leah purchased a subscription.
Subscribed
Suzanne purchased a subscription.
Subscribed
Debbie purchased a subscription.
Subscribed
Laura purchased a subscription.
Subscribed
MOHAMED NAZIH purchased a subscription.
Subscribed
June purchased a subscription.
Subscribed
Dale purchased a subscription.
Subscribed
Kathryn purchased a subscription.
Subscribed
Mahendra purchased a subscription.
Subscribed
Wendy purchased a subscription.
Subscribed
Stacey purchased a subscription.
Subscribed
Aaron purchased a subscription.
Subscribed
Burt purchased a subscription.
Subscribed
Kelly purchased a subscription.
Subscribed
PATRICIA purchased a subscription.
Subscribed
Barbara purchased a subscription.
Subscribed
Chuck purchased a subscription.
Subscribed
Jamie purchased a subscription.
Subscribed
David purchased a subscription.
Subscribed
Valerie purchased a subscription.
Subscribed
Glenn purchased a subscription.
Subscribed
Divyasom purchased a subscription.
Subscribed
Tina purchased a subscription.
Subscribed
Katherine purchased a subscription.
Subscribed
Brittany purchased a subscription.
Subscribed
Jonalyne purchased a subscription.
Subscribed
Erik purchased a subscription.
Subscribed
Sandra purchased a subscription.
Subscribed
Todd purchased a subscription.
Subscribed
Fabian purchased a subscription.
Subscribed
Jodi purchased a subscription.
Subscribed
Carol purchased a subscription.
Subscribed
Deborah purchased a subscription.
Subscribed
Rebel purchased a subscription.
Subscribed
Karen purchased a subscription.
Subscribed
Robert purchased a subscription.
Subscribed
Brian purchased a subscription.
Subscribed
Mary K purchased a subscription.
Subscribed
Deva purchased a subscription.
Subscribed
Teresa purchased a subscription.
Subscribed
Lindsey purchased a subscription.
Subscribed
JOSEPH purchased a subscription.
Subscribed
Thomas purchased a subscription.
Subscribed
Jeff purchased a subscription.
Subscribed
Roger purchased a subscription.
Subscribed
Krasimir purchased a subscription.
Subscribed
HENRY purchased a subscription.
Subscribed
Elizia purchased a subscription.
Subscribed
Maria purchased a subscription.
Subscribed
LaKeita purchased a subscription.
Subscribed
ERIC purchased a subscription.
Subscribed
Jamie purchased a subscription.
Subscribed
Bryan purchased a subscription.
Subscribed
Mitchell purchased a subscription.
Subscribed
Thomas purchased a subscription.
Subscribed
john purchased a subscription.
Subscribed
Marianna purchased a subscription.
Subscribed
MELVIN purchased a subscription.
Subscribed
Rachel purchased a subscription.
Subscribed
RYAN purchased a subscription.
Subscribed
Samantha purchased a subscription.
Subscribed
Marilyn purchased a subscription.
Subscribed
Thomas purchased a subscription.
Subscribed
Steven purchased a subscription.
Subscribed
Kevin purchased a subscription.
Subscribed
John purchased a subscription.
Subscribed
DAVID purchased a subscription.
Subscribed
Cerissa purchased a subscription.
Subscribed
Rick purchased a subscription.
Subscribed
Kathleen purchased a subscription.
Subscribed
Andrew purchased a subscription.
Subscribed
Jena purchased a subscription.
Subscribed
Joan purchased a subscription.
Subscribed
Anthony purchased a subscription.
Subscribed
Keith purchased a subscription.
Subscribed
Hasonna purchased a subscription.