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Steven was knowledgeable and thorough in his information about the product and what is offered. He was empathetic to my situation. He went above and beyond answering all of my many questions. Excellent service!
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It is what it advertised to be. Professional quality training and CPE tracking and certificates; systems knows AZ CPA CPE requirements and categories. I've needed help on several occasions and the assistance was quick and effective; however, there were some problems with data entry. The assistance sometimes asks for input, but when I try to type it is dissallowed for some reason. On several occasions I had to close the popup to get it out of my way.
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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,
test, 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.
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.
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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.
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1.5 Credits
Add to WatchlistThis course is set to be rescheduled shortly. Please fill out the short form below, and we'll let you know as soon as the course becomes available
1. How can I earn Continuing Education credits for live webinars?
A: To earn credits, you must register for the webcast before it begins. Attend the entire live webinar and respond to polling questions if supported.
2. When will I receive my Continuing Education Credit Certificate?
A: You'll receive your certificate within 24 hours after each webinar.
3. What's the basis for credit issuance?
A: Credits are issued on a 50-minute credit hour basis.
4. What if I can't use the polling feature on a web browser?
A: The polling feature is only supported on the Zoom desktop and mobile app. You can provide responses in the chat if needed.
5. Are these live events or recordings?
A: Some events may be recorded, but instructors will be available for questions during/after the webinar.
6. Do myCPE courses meet professional standards?
A: Yes, myCPE meets global Continuing Professional Development (CPD-IES7) standards for various accounting and financial professions. Confirm with your licensing organization if needed.
7. Where can I manage my certificates and credits?
A: You can manage them through your certificate dashboard when logged into your account.
8. Is myCPE accredited for Continuing Professional Education in the United States?
A: Yes, myCPE is accredited by various professional organizations, making it suitable for fulfilling continuing education requirements.
9. Who can take myCPE courses?
A: myCPE courses are suitable for professionals with 100+ designations, including CPAs, CMAs, CFAs, and more.
10. What's the refund and complaint resolution policy?
A: To learn about the refund and complaint resolution policy, click here for details.
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