21 CFR Part 11 - Electronic Record and Signature Validation

Duration: 60 Minutes
flat 40% off on this webinar use promo code
This webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.
21 CFR Part 11
Instructor: Edwin Waldbusser
Product ID: 508215
FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained.

Objectives of the Presentation
  • Company certification
  • Records covered
  • Audit trails
  • Open /closed system access rules
  • Electronic signatures
  • Training requirements
Why Should you Attend
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483's at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would "selectively enforce" sections of the regulation. This webinar will explain what all these means.

Who will Benefit
  • Quality Managers
  • Quality Engineers
  • Small Business Owners
  • GxP Professionals
  • Consultants
  • Quality VPs
  • IT VPs
  • Engineering personnel
  • Management
$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:
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
View More