IEC 62304: Medical Device Software Development and Validation

Duration: 75 Minutes
Software is a critical element because it ensures product quality and patient safety. Hence it always draws the attention of regulatory agencies such as the USFDA, EMA, TGA etc. The benefits accruing from devices and processes automated through software have been recognized.
IEC 62304 Standard
Instructor: Chinmoy Roy
Product ID: 500102
The requirement for Software Quality Assurance (SQA) has been in place for quite sometime. In spite of it’s existence for all these years, regulatory interpretations, inspections and enforcement practices keep evolving. This evolution is the reason that companies are still unsure what and how much to validate.

The key objective of this webinar is to focus on software validation requirements and methodology. It provides conceptual ways for meeting compliance requirements. Addressed at this webinar will be elements of software validation as enumerated in the IEC 62304 standard. While this standard applies to medical device software, a significant portion of this standard also applies to the discipline of software development and validation in general (SDLC) Industry "best practices" and FDA Warning Letters will be presented.

Why Should you Attend:
Software is very critical to Quality. A disciplined approach is a key factor in developing software to “zero defect” tolerance. While this disciplined approach has been in existence for years, regulatory auditors have raised good questions in their effort to seek how much we are in control of our software. Attend this webinar to understand the fundamental principles of software development and validation through the eyes of a regulator. This webinar addresses the "common language of issues pertaining to the software issues” and a documentation strategy required to maintain a defensible compliance strategy that meets compliance requirements.

Objectives of the Presentation:
Topics covered in this webinar include:
  • Regulatory requirements for software Design Control (USFDA’s QSR 820.30)
  • General principles of Software Validation guidance of regulatory agencies
  • Overview of the IEC 62304 (SDLC) standard
  • Critical implementation issues of IEC 62304 (SDLC)
  • Keys to a successful implementation of IEC 62304 (SDLC)
  • How is compliance with IEC 62304 (SDLC) audited
Who can Benefit:
  • Device Manufacturers
  • Equipment Manufacturers
  • IT Personnel
  • Software Engineers
  • Engineering Designers
  • Risk Managers and Others Performing Risk Management Activities
  • QA
  • QC
  • Manufacturing
  • Validation Consultants
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Instructor Profile:
Chinmoy Roy has 40+ years of experience in the US Life sciences industry. He is an internationally recognized Subject Matter Expert (SME) in Data Integrity, CSV, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu's annual conference for Asia Pacific, etc. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training.

He was one of the early implementers of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and Validators to design the system and obtain ‘fit for use’ certification in 1999. His pioneering efforts in implementing that system while employed by Genentech, was a precursor to FDA's issuance of Part 11's Scope and Application guidance in 2003.
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