for Enterprise Subscriptions
$25/user
(Minimum 10 users)
$199/user
(Minimum 3 users)
You have Not Selected the Monthly or Annual Plan
Create your Free Account | Get Unlimited Access only @$199/Year ( View Details )
Trusted by 250,000+ Professionals for Continuing Education
Already have an account? Log In
To Continue using Trial, please verify your email address
You can cancel anytime during your trial period.
Trusted by 250,000+ Professionals
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
Select the topics of your interest to receive Webinars/Virtual Events/E-Books/Podcasts of your interest.
Effective
and compliant computer system validation is critical to any pharmaceutical or
FDA-regulated organization. During the past 30 years, best practices that have
been developed will ensure that validation activities are cost-effective while
meeting all aspects of FDA compliance.
While
these practices have been employed, companies are being forced to do more work
with fewer resources, leading to errors noted in citations, particularly in
Warning Letters in the past 10 years. This has resulted in consequences
including heavy fines and operational shut-downs.
Both
FDA and industry recognize the need to review current practices to ensure they
meet the standards for creating data with integrity and maintaining it as such
throughout the entire life cycle.
In this CPE webinar, you will
learn about these FDA trends in compliance and enforcement, as they relate to
data integrity, and how to improve your practices to meet compliance
requirements.
In this CPE webinar on information technology,
we will focus on the importance of ensuring that the validation of an
FDA-regulated computer system will meet compliance guidelines. This includes the
development of a company philosophy and approach and incorporating it into an
overall computer system validation program and plans for individual systems
that are regulated by FDA. It also requires a recognition that Data Integrity
issues continue to be a strong area of focus by the FDA during an inspection,
and there are many examples and best practices that will be covered in this
webinar to address them.
Data governance will also be explored in terms of developing a framework
for an organization. The key facets of the framework will
be highlighted and examples provided to demonstrate the benefits of governing
data effectively. When data is readily available and easy to access, users can
make decisions more expeditiously and appropriately. The data structure must be
considered to build consistency in the use of terminology and key phrases. This
leads to improved search capability.
You’ll learn the best industry practices
for organizing a data governance program in this CPE course.
As
FDA continues to evolve and change due to the many factors that influence the
regulatory environment, companies must be able to adapt. New technologies will
continue to emerge that will change the way companies do business. While many
of these are intended to streamline operations, reducing time and resources,
some unintentionally result in added layers of oversight that encumber a
computer system validation program and require more time and resources, making
the technology unattractive from a cost-benefit perspective.
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.
21 Ratings
Excellent
13
Very Good
6
Average
2
Poor
0
Terrible
0
RS
Feb 21st, 2024
I thought the course was well organized, and very informative on the subject matter.
TT
Sep 4th, 2023
great
MO
May 9th, 2022
All is good. The only thing I'd like is if you have more classes later in the day. Your schedule is very early for us in Arizona. I can't attend most of them.
JS
May 10th, 2022
Very informative about data
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.
CPE
General
CPD
CE
Your inquiry has been received. We will notify you once this webinar is available
CloseThank you for subscribing 7 Days Free Trial.
Experience myCPE at its best! Upgrade your browser for a more interactive, user-friendly interface, and stay ahead in your professional development journey.
Upgrade NowWe were looking so hard for you now that you are finally here, So would you tell us how you found out about us?
Thank you for submitting your inquiry! We will contact you soon.
Close