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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!
Great service and very patient as I asked several questions. Steven answered all my questions and helped me make the right decision in my subscription purchase. Thank you.
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.
Great customer service. Classes are pertinent. Great value
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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.
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.
Duration
Course Level
Instructional Method
Pre-requisites
Advance Preparation
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.
14 Ratings
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Oct 30th, 2023
Really good course addressing a lot of key concepts.
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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