Applying CSA Concept To
Data Integrity – Updates on ISPE GAMP GPG
DI & CSA Appendix

There are two parts to this webinar:

  1. CSA and data integrity GPG DI alignment
  2. Insert more data integrity so we don’t bore people with CSA

Hear directly from the source, FDA – Industry CSA Team & Colleagues in a Panel setting discussing the upcoming ISPE GAMP Good Practice Guide (GPG) Data Integrity (DI) By Design and the CSA Appendix.  Attendees will gain insight into the importance of data integrity, and gain a complete understanding of the key requirements and essentials needed to address these ongoing challenges.  Learn how to execute data integrity by design for the management of GxP regulated records and data, ensuring the completion, consistency, and accuracy throughout the process.  Understand how CSA is transformative to streamline business processes with quantitative and qualitative analysis to optimize your organization’s operational performance.

Top Reasons to Attend:

  1. Recent intensification of data integrity sanction by regulators
  2. The value of avoiding the mistake of focusing on regulatory risk over the patient risk
  3. How to remediate deficiencies or lack of controls
  4. CSA can be applied for any risk management methodology and uses patient safety and product quality – data integrity as the common denominator
  5. CSA concepts apply broadly to all validation for the intended use of a computerized system
  6. Automation is supposed to improve data integrity and promote better use of data for the benefit of patient safety and product quality
  7. CSA is the application of critical thinking and risk-based principles when developing a computerized system lifecycle strategy in support of data integrity
  8. The applicability of direct and indirect risks to patient safety and product quality and data integrity

SPEAKERS

Raechelle Raimondo

Executive Director – Global Systems Assurance, AbbVie (formerly Allergan)


Mrs. Raimondo is an experienced leader with over 20 years of Life Sciences industry experience in the implementation of compliant and business driven global systems using a risk-based approach.  By applying strategic and critical thinking she has successfully established practical policies and practices for regulated & non-regulated computer systems to achieve quality business outcomes.  In today’s rapidly changing world of technology, she has shifted her focus and passion to collaborate with others to effectively implement Computer Software Assurance (CSA) and automation tools within the pharmaceutical industry.

Senthil Gurumoorthi

MS MBA, Associate Director IT, Gilead Sciences


Senthil Gurumoorthi leads IT Quality Assurance function at Gilead Sciences, which provides independent oversight for GxP IT Infrastructure & Platforms and manages IT Inspection and audit readiness program. He has over 16 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.

Ken Shitamoto

MS, Sr. Director IT, 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.

Shana Kinney

Associate Director, Validation, REGENXBIO Inc.


Shana Kinney has over 14 years’ progressive experience in the biosafety testing, molecular diagnostic medical devices, and gene therapy industries. She has served as a validation engineer, quality engineer, software quality assurance, and computer systems validation engineer and is currently working at REGENXBIO Inc. as an Associate Director, Validation building a computer systems and equipment validation program for a rapidly growing startup. Shana is a co-author of the ISPE Good Practice Guide for IT Infrastructure and a member of the ISPE Val 4.0 Committee. She is certified by ASQ as a Six Sigma Green Belt, Software Quality Engineer, and Quality Engineer with a Bachelor’s degree in Applied Mathematics and Master’s in Applied Statistics.

Khaled Moussally

Head of Quality Management Systems


A Versatile global Quality / IT executive with over 25+ years of quality and compliance, experience in highly regulated life science industries (Medical Device, Bio-tech, Pharmaceutical and Tobacco). Deep understanding in the Manufacturing processes, Equipment validation and Lab Information Systems. Extensive background in Quality Management Systems, regulatory inspections and internal audits. Member of an FDA/Industry CSV Consortium, focusing on developing risk-based recommendation to reduce time and cost in validating software.