21 CFR Part 11 compliance for Electronic Medical Records

Duration: 90 Minutes
flat 40% off on this webinar use promo code
This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.
Part 11 Compliance for Electronic Medical Records
Instructor: Alfonso Fuller
Product ID: 502044
Objectives of the Presentation
  • Review of current status of 21 CFR Part 11
  • What is the relationship between "validation" and "part 11 compliance" to electronic medical records?
  • What do I have to do today to be in compliance?
  • What changes can I expect to see in Part 11?
  • When will I need to be in compliance?
  • What is the future part 11 likely to look like?
  • How can I best integrate part 11 compliance into my quality system?
  • How can I ensure what I do today will stand inspection tomorrow?
Why Should you Attend
Electronic Medical Records are the future. Some facilities and doctors are already using this cutting edge technology and the medical community in general is moving in this direction.

FDA regulations governing electronic records and electronic signatures will be enforced upon these systems as they are used and become more prevalent. This presentation analyzes the regulations and provides concrete guidance on compliance.

Who will Benefit
  • Management responsible for operational and quality systems (system owners)
  • QA Directors, Managers and personnel
  • IT / IS managers and personnel
  • Software validation and software quality managers + personnel
  • Consultants charged with creating or evaluating part 11 programs
  • Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
  • Quality auditors responsible for auditing and evaluating part 11 compliance
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers. He is a consultant, writer, and frequent presenter nationwide on quality system and software quality issues. His speaking appearances have included numerous national and statewide conferences.
View More