FDA Discusses Data Integrity:
The Challenges & CSA Application

January 26th, 2021
1:00 PM — 2:00 PM EST

There are two parts to this webinar:

Data Integrity Challenges and Avoiding Compliance Issues
Computer Software Assurance (CSA) Application to Data Integrity

Beyond the conversation of ALCOA and ALCOA+, the panelists will discuss data integrity challenges the industry is facing and the importance of controls around application-related data followed by several of the most common FDA non-compliance findings, where the DI guidance may not have covered. Speakers typically tend to talk about the ways that facilities fail to meet regulatory requirements, however, these panelists will talk about ways that the industry may exceed regulatory requirements (i.e., best practices).

The second and hottest topic of this webinar is CSA –

“Computer System Validation” (CSV) has remained mostly unchanged for the past two decades. General Principles of Software Validation (GPSV), issued by the FDA in 2002, has been and continues to be the primary tool industry uses as guidance on this topic. CSV, as it stands today, is a documentation heavy exercise Documentation is done at the expense of critical thinking and testing.

“Computer Software Assurance” (CSA) is a new way of thinking that emerged from a collaboration between the industry and the FDA’s new “Case for Quality” (CfQ) initiative. CSA brings about a paradigm shift in this approach by encouraging critical-thinking over documentation.

During this webinar you will understand how CSA can be adapted to benefit your organization and be applied to Data Integrity.

Top Ten Benefits

Hear from industry thought leaders on their data integrity experiences
Latest Updates on the FDA CSA draft guidance from FICSA Team
FDA’s tips on how companies can meet regulatory requirements
The intent of the Data Integrity guidance
Establishing and maintaining Data Integrity
Handling perceived Data Integrity challenges
See where applying CSA is acceptable regarding data integrity
How Data Integrity (DI) requirements should be treated
Utilizing opportunities to align regulatorily, enforcement and compliance approaches
Understanding Data Integrity as a business process

SPEAKERS

Karen Takahashi

Senior Policy Advisor, Office of Policy for Pharmaceutical Quality, CDER

Karen Takahashi is a Senior Policy Advisor in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality. Prior to January 2015, she spent fifteen years as a Senior Policy Advisor and Compliance Officer in CDER’s Office of Manufacturing and Product Quality. At the beginning of her FDA career, Karen was an Investigator with FDA’s New England District Office. She holds a Master of Science degree from Boston University, and a Bachelor of Science degree from the University of Wisconsin-Madison.

Francisco (Cisco) Vicenty

Program Manager – Case for Quality CDRH | U.S. Food and Drug Administration

Cisco Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017and will improve access and patient outcomes by engaging industry, payers, providers, and patients to increase focus on the quality and performance of medical devices.

Cisco began at the FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance at CDRH. He then worked as a project manager for the FDA’s Case for Quality initiative. Prior to his current role, Cisco was the Branch Chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality, within the Office of Compliance.

Khaled Moussally

EVP Clients & Regulatory Relations, Compliance Group

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.

Stephen J Cook

VP – Validation and Compliance, Compliance Group

Stephen believes that validation focused on partnering with IT and the business leads to innovative solutions and that the best work that happens, happens outside the SOP. He has provided innovative validation solutions, executed countless CSA protocols and written CSA-driven policies and procedures at numerous companies in his tenure with Compliance Group. A proven trainer, Stephen enjoys mentoring and developing the teams he works with. Stephen brings 25+ years of experience in quality manufacturing, facilities and equipment design, build and testing, and software validation to Compliance Group. He was previously held positions with Baxter Healthcare and Fresenius Kabi USA.

Ken Shitamoto

MS, Sr. Director IT, Gilead Sciences

Ken 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.

Refund Policy

135 E Kings Highway
3rd Floor
Haddonfield, NJ 08033
Email: info@kenx.org
Phone: 858 649 3251

FDA Discusses Data Integrity:The Challenges & CSA Application

SPEAKERS

Karen Takahashi

Stephen J Cook

Ken Shitamoto

FDA Discusses Data Integrity:
The Challenges & CSA Application