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.
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.
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.
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
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
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
|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.|
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.
Participants will receive the following:
- ANSI/AAMI/IEC 62304:2006 Medical device software - Software life cycle processes
- ANSI/AAMI/IEC TIR80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
- 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.
|AAMI Corporate & Institutional Member||
|AAMI Individual Member||