Validation of Software for Regulated Processes: An Overview of AAMI TIR36:2007

Software used to design, develop, manufacture, or otherwise control the quality of medical devices must be validated for its intended use by 21 CFR, Part 820 (FDA’s Quality System regulation).  This regulation covers a very broad scope of software, ranging from simple spreadsheets and database reports to enterprise-wide IT solutions for CAPA and complaint handling.  Based on AAMI TIR36:2007 Validation of software for regulated processes, this AAMI webinar cd bridges the gap between the regulation and industry best practices.  Program speakers provide a high level introduction to the content and structure of the TIR, present some of the validation philosophies that are the foundation for the methods discussed in the TIR, and discuss the practical application of the TIR to common validation challenges and compliance issues.

PROGRAM OBJECTIVES

The webinar challenges the way medical device manufacturers think about validating regulated process software.  Methods suggested in AAMI TIR36 discourage a checklist approach that is overly prescriptive.  Instead, the TIR recommends an approach that emphasizes “critical thinking” and empowers those validating software to take innovative approaches to building confidence in the software for its intended use.  The speakers walk through AAMI TIR36, introduce new validation concepts, and provide practical information on using the TIR to solve daily validation needs in a more value-added way.

PROGRAM-AT-A-GLANCE

  The Primer
 
Where we are
 
Where we would like to be
 
How to get there
 
Critical thinking
  Regulatory Context
 
Automated Processes 21 CFR 820.70(i)
 
Quality System Regulation 21 CFR 820
    Electronic Records 21 CFR 11
    The general principles of Software Regulation
  Software Intended Use
 
Software Purpose and Intent
 
Software Use Requirements
    Software Requirements
  Brief Overview of the Organization and Content of the TIR
    Understanding the Process Being Automated
    The Role of Risk Analysis and Management
    The "Max and Min" Models of Validation
 
The Validation "Toolbox"
  Discussion of Examples from the TIR

 

SPEAKERS

WEBINAR CD

THREE WAYS TO ORDER

  1. Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
  2. Fax - Select and download the order form and fax to 240-396-5781 .
  3. Mail - Select and download the order form and mail with payment to:

    TIR36 Webinar CD Packet
    AAMI Publications
    PO Box 0211
    Annapolis Junction, MD 20701-0211

QUESTIONS?
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031.