RAPS pre-approved webinar on "21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits"
In the course of his discussion, the presenter, David Nettleton will demystify Part 11 and the new European equivalent Annex 11. This session will put participants on the right track for using electronic records and signatures, which will help them to greatly increase productivity.
- Fresno, CA (1888PressRelease) February 12, 2013 - Description:
There are three primary areas in which computerized systems need to show compliance: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.This session will teach participants exactly what is needed to be compliant for all these three areas.
This webinar covers the following areas:
- Which data and systems are subject to the regulations?
- What the regulations mean, not just what they say
- Avoid 483 and Warning Letters
- Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
- Ensure data integrity, security, and protect intellectual property
- Understand the current computer system industry standards for security, data transfer, and audit trails
- Electronic signatures, digital pens, and biometric signatures
- Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures
- SOPs required for the IT infrastructure
- Product features to look for when purchasing COTS software
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
When:February 12, 2013, 10:00 AM PDT | 01:00 PM EDT
By whom:
Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation -Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.
He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects. These have included clinical trial, blood bank, medical devices, document control, corrective action, laboratory instruments, electronic data capture, laboratory information management systems and so on.
An accomplished author, David has written extensively on a range of Compliance issues. He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org), and Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com).
For whom:
The webinar will benefit
- IT
- QA
- QC
- Laboratory Staff
- Managers
- GMP, GCP, GLP professionals
Duration: 75 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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