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.
Program At-A-Glance
| DAY
ONE 8:00 AM-5:00 PM |
— Introduction to FDA Software Regulation — Quality Planning — Software Risk/ Hazard Management — Design and Construction |
| DAY
TWO 8:00 AM-5:00 PM |
— Testing — Configuration Management and Cybersecurity — CAPA |
| DAY
THREE 8:00 AM-5:00 PM |
— Production
and Quality System Software — Overview of 21 CFR Part 11 — Electronic Records and Signatures — Production and Quality System Software Tips |
Who Should Attend?
This course is intended for those who oversee compliance activities related to software validation - regulatory affairs/quality assurance specialists professionals as well as those new to medical device software quality. For those who require technical training on development and validation activities, it is recommended you attend the Software Validation Workshop: Practical Tools & Techniques.
Dates and Hotels
| DATE | LOCATION | PHONE & RATES |
| April 2-4, 2012 | Doubletree by Hilton Hotel Washington DC – Silver Spring 8727 Colesville Road Silver Spring, MD 20910 website |
800-222-TREE or 1-800-HILTONS |
| NOTE: Reservation requests should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. | ||
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 and consultants 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
- ANSI/AAMI/IEC 80001-1:2010 - Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
- AAMI TIR36:2007 - Validation of software for regulated processes
Fees and Registration
Fee includes PowerPoint presentations and case studies; relevant standards and/or technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
| REGISTRATION TYPE | 2012
FEES |
| AAMI Corporate & Institutional Member | $1835 |
| AAMI Individual Member | $1935 |
| Nonmember | $2235 |
| Government Employee | $635 |