Courses

Regulatory Requirements for Software Validation in the Medical Device Industry

This 3 day course focuses on the requirements contained in the Quality System regulation specific to software validation. The course explores the latitude and flexibility of the FDA's expectations and provides conceptual ways to meet compliance requirements. Relevant standards, FDA guidance documents, and other resources will be discussed that assist in determining compliance practices.

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		 Module 1: About this course
Module 2: Introduction to FDA Software Regulation
Module 3: Requirements
Module 4: Risk Management
Module 5: Design and Construction
Module 6: Testing
DAY TWO
8:00 am–5:00 pm		 Module 7: Test Planning and Documentation
Module 8: Quality Planning
Module 9: Configuration Management
Module 10: Cybersecurity
Module 11: CAPA
DAY THREE
8:00 am–5:00 pm		 Module 12: Submissions
Module 13: Production Overview
Module 14: Production/QS Approaches
Module 15: Production/QS Tips
Module 16: Part 11

Who Should Attend?

This course is intended for those who oversee compliance activities related to software validation—regulatory affairs/quality assurance specialist 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 Developing and Validating Software for the Medical Device Industry workshop.

Dates and Hotels

DATE LOCATION PHONE & RATES
May 1-3, 2013 Renaissance Arlington Capital View Hotel
2800 South Potomac Avenue
Arlington, VA 22202
Website

703-413-1300
$199 single/double
Rate though: 4/2/2013
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:

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
FEES
AAMI Corporate & Institutional Member
$1835
AAMI Individual Member
$1935
Nonmember
$2235
Government Employee
$635


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