FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data 1.5 Credits 1.5 Credits
Learning mode
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.
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified in Risk and Information System Control (CRISC) | 1.5 CPE | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified in Risk and Information System Control (CRISC) | 1.5 CPE | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
Credits
1.5
Course Level
Basic
Instructional Method
QAS Self Study
Group Internet Based
Pre-requisites
None
Advance Preparation
None
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.
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.
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.
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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.
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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.
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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.
EL
Really good course addressing a lot of key concepts.
JM
Good training material.
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