Registration Software Validation Requirements and Industry Practice
This 3 day course supplies attendees with information and tools needed to comply with the software validation requirements of the Quality System regulation, and provides guidance on how to implement effective validation programs. In addition, the course includes a discussion on ANSI/AAMI/IEC TIR80002-1 and how it relates to ANSI/AAMI/ISO 14971; an explanation on cybersecurity for networked medical devices containing Off-the-Shelf (OTS) software; an update on Part 11: tips on production and quality system software; and class exercises.
Objective
Upon completion of this course, participants will be able to apply
the principles of software validation to their product, production
process, and quality system. Participants also come away from the
course with an awareness of relevant standards, FDA guidance documents,
and other resources that will assist in defining acceptable compliance
practices.
Format
This 3-day program provides intensive coverage of the elements of
software validation. This highly interactive training format will
include a variety of situational analyses that provide participants
with the opportunity to apply new information to actual software
validation scenarios. Industry "best practices" and FDA
Warning Letters will be presented to demonstrate approaches to validation
and paths to compliance. In addition, participants will work through
workshops that illustrate the various aspects of
a software validation program.
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Who
Should Attend?
Instruction
is geared to professionals directly involved in meeting quality system requirements such as those in regulatory affairs, quality assurance, and software product/process development.
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Faculty
Course faculty are drawn from an experienced group of
quality systems professionals. All course faculty have completed
an instructor training program to ensure consistency and quality
from session to session. The mix of industry leaders, consultants,
and FDA personnel helps to ensure a balanced presentation of the
requirements and paths to compliance.
Course
Materials
Participants will receive the following:
- ANSI/AAMI/IEC 62304:2006 Medical device software - Software life cycle processes
- AAMI TIR32:2004, Medical Device Software Risk Management
- AAMI TIR36:2007 - Validation of software for regulated processes
- Pertinent FDA documents; additional references; and a participant notebook of course materials and case studies
- Continental breakfast, lunch, and refreshments
Fees and Registration
Fees include participant notebook of course materials and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
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