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Webinar: 21 CFR Part 11 and Annex 11; Compliance with Electronic Records, Signatures, and Validation

Date:  April 21, 2016
Time:  1:00 PM EST | 10:00 AM PST
Duration:  90 Min + Q
Price:  $375.00

Webinar Description


This webinar explains how to use electronic records and electronic signatures to significantly reduce costs. Learn exactly what is needed to be Part 11 and Annex 11 compliant in all three compliance areas: IT infrastructure SOPs, software product features, and 10-step risk-based validation. You will be able to go paperless, immediately improve productivity, and reduce software implementation costs.  

All attendees will receive:
  • Course presentation
  • Certification of Attendance from GXP Conferences


Webinar Objectives


  • Understand which systems need and don’t need to be validated.
  • Learn compliance for electronic records: security, data transfer, and audit trails
  • Avoid 483 and Warning Letters.
  • SOPs required for the IT infrastructure.
  • Product features to look for when purchasing COTS software.
  • Electronic signatures, digital pens, and biometric signatures.
  • Save money and improve data integrity, security, and protect intellectual property.
  • Everything you need to know about Part 11 and Annex 11 made understandable.


Who Should Attend
  • Computer users
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP professionals
Please forward to collegues and appropriate departments.

GxP Conferences and eLearning
PO Box 335
Medford, NJ 08055
t. (609) 859-3455
f. (856) 810-7339

10AM EST - 1:00PM PST

Instructor Profile

nettletonComputer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 200 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - which provides fill-in-the-blank templates for completing a COTS software validation project.

[ read more... ]

About GxP Conferences
GxP Compliances is an emerging leader in pre-market and post-market conformity and compliance online webinars tailored to meet the needs of those in a wide variety of regulated industries. Utilizing our innovative, technologically-advanced tools individuals have exclusive access to exceptional cutting-edge live series and individual training modules providing in-depth information related to conformity and compliance. Our unique online conferences have been created with the utmost in quality, with compliance and conformity in the forefront of all of our presentations.
[ read more here ]

21 CFR Part 11; Compliance with Electronic Records, Signatures, and Validation

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Are you a high-caliber professional with extensive knowledge in conformity and compliance for regulated industries that you’d like to share through our webinars? If so, then let GxP Conferences consider you as an upcoming speaker. Click below for details on how to join our team of highly-qualified speakers.

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