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Align with FDA’s New Computer Software Assurance Draft Guidance

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FDA-Industry CSA team meets ISPE GAMP® – A collaboration between the FDA-CSA Industry Team and ISPE GAMP® CSA Team.  Hear directly from ISPE GAMP® contributing authors for the upcoming draft ISPE Data Integrity by Design, where they establish the relationship between Computer Software Assurance and GAMP5 .   This webinar will discuss the paradigm shift and the changing landscape for computer system validation.

 

Top Reasons to Attend

  1. Proceeds from this event will be donated to We Hope (www.wehope.org).  Information on this organization is below.
  2. Opportunity to submit your questions in advance and in real time
  3. Understand key elements of CSA
  4. Understand the relationship between CSA and GAMP
  5. Hear pragmatic guidance for implementation drawn from lessons learned in the field
  6. Understand how to implement CSA concepts now
  7. Learn the best sources for more knowledge

 

Attendees will have the option to donate and support the charity WeHope, for participation in this webinar.

 

Covid-19 update: https://www.wehope.org/public-safety-announcement

 

About WeHOPE:

The mission of WeHOPE is to help people become healthy, employed, and housed using innovative solutions. WeHOPE’s Mobile Homeless Services meets the needs of the homeless where they are through initiatives that include access to free showers, laundry, safe parking for vehicle dwellers, virtual medical assessments, and comprehensive case management to assist in securing permanent housing. WeHOPE currently serves 4 counties and 15 cities throughout the Bay Area, including: San Jose, San Francisco and Oakland.

Click Here To Register For The Webinar

 

 

Speakers

Ken Shitamoto

Senior Director, Gilead Sciences

Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.

Senthil Gurumoorthi

Director, Gilead Sciences (Moderator)

Senthil Gurumoorthi leads IT Quality Assurance function at Gilead Sciences, which provides independent oversight for GxP IT Infrastructure, Applications & Platforms and manages Vendor Oversight, IT Inspection and audit readiness programs. He has over 17 years of diverse experience in biopharmaceutical business ranging from pre-clinical, R&D to manufacturing with leadership expertise on Quality Assurance, Risk Management, Inspection/Audit Management, and Vendor Management. Additionally, as certified Auditor conducted ISO and Part 11/Annex 11 Audits globally.

He holds B.E in Electronics & Communication from PSG College of Technology, MS in Electrical Engineering from New Jersey Institute of Technology and Masters in Business Administration (MBA) from Imperial College London.

Khaled Moussally

Executive Vice President, Compliance Group

Khaled is a Quality & Compliance executive and a thought leader providing cutting-edge solutions to Life Sciences industry. After spending over 25+ years with corporate in IT, Manufacturing and Quality, Khaled transitioned into consulting to bring about a paradigm shift in Quality & Compliance by leveraging his experience with regulatory agencies. Khaled is a key participant of the MDIC “Case for Quality Initiatives” and a member of the “FDA CSV Industry team” contributing to the FDA draft guidance “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. Khaled has co-presented with the FDA in numerous industry conferences on how to reduce CSV cycle times while enhancing quality by applying CSA concept.

Kevin Martin

Managing Partner, Azzur Group

Kevin Martin serves as Managing Partner, Azzur Group, LLC and General Manager, Azzur Group IT. Kevin has more than 40 years of FDA-regulated industry experience that includes management positions at Wyeth and McNeil Pharmaceutical. He is currently a General Manager for Azzur IT and a member of the Azzur Group Board of Directors. He was a member of the PhRMA Computer Systems Validation Sub-Committee (responding to the FDA’s issuance of the 1983 “Blue Book”), was the Core Team Secretary for the PDA Part 11 Task Group (working alongside FDA’s Paul Motise to develop industry guidance) and is a former Chair of the GAMP Americas and GAMP Global Steering Committees, and a contributor to several GAMP Good Practice Guides and Special Interest Groups.