Software Process Verification and Validation

Duration: 60 Minutes
The FDA's analysis of 3140 medical device recalls reveals that 7.7% of them are attributable to software failures. Of those software related recalls, 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. Software verification and validation practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls.
software validation
Instructor: Dev Raheja
Product ID: 500251

Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR ยง820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system

Why Should you Attend:
Software safety is a poorly understood science in the medical device industry. This knowledge is available from other safety critical industries and the FDA guidance makes it easier to implement.

Objectives of the Presentation:
  • Regulatory Requirements for Software Validation
  • Benefits of Software Validation
  • Quality System Regulation vs Pre-Market Submissions
  • Context for software validation
  • Software requirements in specifications
  • Verification and Validation process
  • IQ/OQ/PQ in software verification
  • Software development as part of system Design
  • Software is Different from Hardware
  • Time and effort required
  • Software life cycle verification
  • Software validation after a change
  • Validation Coverage
  • Validation of Off-the-Shelf Software and Automated Equipment
  • Independence of Review
Who can Benefit:
  • Software Engineering Managers and Engineers
  • Hardware Engineering Managers and Engineers
  • Entire QA Staff
  • Entire Regulatory Staff
  • R&D Engineers
  • Marketing Staff
$375
Recorded Session for one participant
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Instructor Profile:
Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont.

He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement and is Senior Member of IEEE. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more books Assurance Technologies Principles and Practices, and Safer Hospital Caret. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He has done seminars on Risk Management, Process Validation, Software Reliability, Software Safety, Design Control, and Corrective and Preventive Action (CAPA) System.
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