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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.
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There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. The rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.
The system must specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result.
A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets its responsibility for meeting it.
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.
In this Online CPE webinar, speaker Carolyn Troiano will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
Click here to access Online CPE webinars on Computer Software and Applications | Information Technology |
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
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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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