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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 (CSV) is a documented process that is required by regulatory
agencies around the world to verify that a computerized system does exactly
what it is designed to do in a consistent and reproducible manner. These
regulatory agencies require CSV processes to confirm the accuracy and integrity
of data in computerized systems to ensure product safety and effectiveness.
IQ, OQ, PQ
protocols are methods for demonstrating that equipment being used or installed
will offer a high degree of quality assurance such that production processes
will consistently manufacture products that meet quality requirements. Validation
Summary Reports provide an overview of the entire validation project. Once the
summary report is signed, the validation project is considered to be complete.
When validation
projects use multiple testing systems, some organizations will produce a
testing summary report for each test protocol, and then summarize the project
with a final Summary Report. The amount of detail in the reports should reflect
the relative complexity, business use, and regulatory risk of the system. The
report is often structured to mirror the validation plan that initiated the
project.
Following are the major topics covered on Day 2 of this CPE Webinar on Information Technology:
This CPE course is designed to completely immerse you
in computer system validation (CSV). It delivers comprehensive details of the
regulations impacting your systems and hands-on practice writing validation
documents.
During boot
camp, we will explore both a traditional waterfall approach to validation and a
Computer Software Assurance (CSA) approach that is supported by FDA. CSA
focuses on critical thinking and may be done according to an agile methodology,
using automated testing to improve the speed and quality of the validation
effort. We will highlight the key differences and what must be done to succeed
with either of the two methodologies.
We will also
discuss industry best practices and areas of potential confusion and risk. Both
compliance with data integrity and 21 CFR Part 11, FDA’s guidance on electronic
records (ER) and electronic signatures (ES) will be covered.
Boot camp is tough and challenging.
It is a
three-day complete immersion in the validation process. Participants will work
in focused teams to complete hands-on validation activities through
instruction, exercises, and case scenarios.
The course moves quickly and participants will change gears often to
keep interested high and accommodate multiple learning styles. A balance of
instructor lectures, reading materials, exercises, and case studies keeps
energy levels high and challenges the participants.
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#: GEHNZ) has entered into an agreement with the Internal Revenue Service, to meet the requirements of 31 Code of Federal Regulations, section 10.6(g), covering maintenance of attendance records, retention of program outlines, qualifications of instructors, and length of class hours. This agreement does not constitute an endorsement by the IRS as to the quality of the program or its contribution to the professional competence of the enrolled individual. Credit earned by attendees with a PTIN will be reported directly to the IRS as required of all providers. To ensure your CPE hours are reported, update your profile in My Account to include your PTIN number. Please note: IRS CE is only mandatory for EAs and ERPAs. For all other tax return preparers, CE is voluntary.
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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LH
Mar 30th, 2022
This is a great class and I really appreciate the information. Everything is relevant, and easily transfers to other industries.
6 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
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