AGENDA
9:00 ET
Exhibitor Showroom and Virtual Platform Open House
10:15 ET
Chairman's Opening Remarks
10:15 - 11:00 ET
FDA Releases Computer Software Assurance (CSA) Guidance - Get Up-to- the-Minute Details
Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group; Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA (Invited); Des Chesterfield, Global Director Engineering, Quality, Web, and IOT Systems, Ortho Clinical Diagnostics; Louie Rayal, Senior Director, IT Quality Regulatory and Compliance, Abbott, Jason Spiegler, Senior Director of Strategic Initiatives, Siemens (Invited)
11:00 - 11:30 ET
Computer Software Assurance Journey (CSA) - Challenges, Breakthroughs and Measures of Success
Calvin Kim, Head of Quality Systems and Validation, Samsung Biologics (Invited)
11:30 - 12:00 ET
Reflections - Changes in GAMP® 5 2nd Edition and CSA Explained
Geetanjali Abbi, Director Validation and Swetha Krishnan, Senior Director, Quality Systems & Compliance, Alkermes; Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group
12:00 - 1:00 ET
Networking Luncheon
1:00 - 1:30 ET
Journey to a Successful CSA Implementation – Case Study
Louie Rayal, Senior Director, IT Quality Regulatory and Compliance, Abbott
1:30 - 2:00 ET
Future of CSV - Apply CSA to Modern Technologies
Madhavi Ganesan, Life Sciences Solutions Director, KPMG
2:00 - 2:30 ET
Exhibitor Showroom and Refreshment Break
2:30 - 3:00 ET
How to Implement and Measure Success in CSV/SA Personnel Training
Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics
3:00 - 3:30 ET
Incorporating Effective SOPs in Training Programs – It’s Not Just for the What
Nathan Pofahl, Associate Director GxP Learning, Ultragenyx
3:30 - 4:00 ET
Exhibitor Showroom and Refreshment Break
4:00 - 4:30 ET
Understand the Intersection of Data Integrity Compliance and CSA
Scott Cady, Senior IT Quality & Compliance Consultant, Azzur Group
4:30 - 5:00 ET
Examining the Role of Quality - From Policeman to Partner
Lizzandra Rivera, Director IT Quality, Alexion Pharmaceuticals
5:00 - 5:30
Critical Thinking on Critical Thinking
Ken Shitamoto, Executive Director, Gilead Sciences
5:30 ET
Networking Welcome Reception
7:15 EST
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 EST
Select Between Knowledge Exchange Sessions
Software Fundamentals - Learn How to Write Exemplary Test Scripts
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
Conduct a 21 CFR Part 11 Electronic Records Gap Analysis
Laurent Saugrin, CSV/CSA Associate Director, CAI
Data Integrity Process Mapping - How to Identify and Mitigate Gaps
Shana Kinney, Director, Validation, and Michele Bastani, Senior Manager, Validation, REGENXBIO
8:45 - 10:15 EST
Select Between Knowledge Exchange Sessions
Top Tips for Building a Risk-based CSV Program
Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic; Pritam Khade, Director of Quality Assurance, AbbVie
Risk-based IT Infrastructure and Network Qualification
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
Building and Managing a Data Integrity Program
Ivan Soto, Senior Director Quality Assurance Validation, Sarepta Therapeutics
10:15 - 10:45 EST
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 EST
Select Between Knowledge Exchange Sessions
Practical Approach to Transition from CSV to CSA – Pharma Perspective
Bhaska Aryasomayajula, Director, IT/QA, Bristol-Myers Squibb
Conducting Inspections of Computer & Software Systems
Daniel Walter, Policy Analyst, CDRH FDA (Invited); Jason Spiegler, Senior Director of Strategic Initiatives, Siemens
Using Audit Trails to Drive Data Integrity
Joseph Zec, Associate Director, Information Systems Manager, Vertex Pharmaceuticals
11:35 - 12:15 EST
Select Between Knowledge Exchange Sessions
Benchmark Your CSA Approach with Your Peers - Insight from an In-depth Industry Survey
Madhavi Ganesan, Life Sciences Solutions Director, KPMG
Mastering Remote CSV & SA Inspections Beyond Covid
Gaurav Walia, Senior Global Director of Business Development, PQE Group
Establish Effective Governance for Data Analytics
Geetanjali Abbi, Director Validation, Alkermes
12:15 EST
Exhibitor Showroom and Grab & Go Lunch
12:45 -1:25 EST
Select Between Knowledge Exchange Sessions
Configuration and Change Management of Computer Systems
Jonathon Thompson, Principal Consultant, CAI
Effective Risk Management for Software Applications
Louie Rayal, Senior Director, IT Quality Regulatory and Compliance, Abbott Stephen Cook, VP – Validation Quality & Compliance, Compliance Group
Data Migration Strategies to Hosted Cloud Environments
Rosalind Beasley, VP Digital Innovation, Dot Compliance
1:35 - 3:05 EST
Select Between Knowledge Exchange Sessions
Best in Class SOPs, Templates, Checklists and Master Plans
Bryan Ennis, CEO, BTR
Qualifying SaaS, IaaS, and Other Cloud Platforms
Joanne Goldberg, Senior Principal Quality Systems Specialist, Global IT Quality & Compliance, Medtronic Pritam Khade, Director, Global Quality Compliance, AbbVie
Using Risk Management in Data Integrity Programs
Chinmoy Roy, Senior Industry Consultant, ValGenesis, Inc.
3:05 EST
Exhibitor Showroom and Afternoon Stretch
3:35 - 4:15 EST
Select Between Knowledge Exchange Sessions
Create and Use a Checklist for Conducting a GAMP® 5 Assessment
Mehron Mirian, Director of Automation Services, VTI Life Sciences
Validate Mobile Devices and Software Applications – Minimize the Effort and Maximize the Value
Lou Poirier, Director, Quality Systems, Insulet
Ensuring CSV and DI Programs are Inspection Ready
Kalpesh Patel, MBA, PMP, CSM, Associate Director, QA, BeiGene
4:25 - 5:05 EST
Select Between Knowledge Exchange Sessions
Navigate the Interrelationship Between QA, Validation, and IT
Ricardo Torres-Rivera, CEO/President, Xevalics Consulting
Simplify Periodic Review of Computerized Systems
Lizzandra Rivera, Director IT Quality, Alexion Pharmaceuticals
Create a Culture of Quality that Minimizes Data Integrity Gaps
Matthew LaPierre, Data Integrity Lead, Jackson Scott Consulting
5:05 EST
Close of Day 2
7:15 EST
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 EST
Select Between Knowledge Exchange Sessions
CSA Retrospective - 20/20 Hindsight
Ken Shitamoto, Executive Director, Gilead Sciences
Create a Quality Agreement with SaaS Providers
Laurent Saugrin, CSV/CSA Associate Director, CAI
Understand the Benefits of Electronic CSV Platforms
Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, and Jonathan Meuzelaar, Director, Quality Systems, Compliance Group; Des Chesterfield, Global Director Engineering, Quality, Web, and IOT Systems, Ortho Clinical Diagnostics
8:45 - 10:15 EST
Select Between Knowledge Exchange Sessions
Panel Discussion: Aligning CSV Programs with CSA - Insight from the Front Line
Laura Berberian, Manager, Quality Assurance Validation; Matt Ostrowski, QA Validation and Digital Quality, Brian DiVista, Associate Director, Computer Systems Validation, ElevateBio; Derek Hughes, Vice President, U.S. Sales, Kneat
Learn How to Conduct Risk-based Impact Assessments of Computer Systems
Geetanjali Abbi, Director Validation, Alkermes
Validation of MES and Enterprise Architectures
Esra Guven, Associate Director, GIS-Computer Systems Validation, Apotex, Inc.
10:15 - 10:45 EST
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 EST
Select Between Knowledge Exchange Sessions
Modernized Approach to Software Risk Assessments
Bhaska Aryasomayajula, Director, IT/QA, Bristol-Myers Squibb
Software Upgrades on Cloud 9 – Strategies for SaaS-based Change Managemen
Joseph Zec, Associate Director, Information Systems Manager, Vertex Pharmaceuticals
Data Integrity Audits – The Framework for Successful Remediation
Jacob Hodovsky, Computer Systems Validation and Project Manager, CAI
11:35 - 12:15 EST
Select Between Knowledge Exchange Sessions
Controlling Risk in Decommissioning and Retirement of Computer Systems
Curt Gendler, Senior Quality Engineer, AstraZeneca Biologics
Understand the Regulatory Landscape for Artifical Intelligence/Marchine Learning (AI/ML) Solutions
Loganathan Kumarasamy, Head US Validation & Compliance Services, Zifo RnD Compliance Services
Develop a Strategy to Transition to Paperless Validation
Leslie Lighton-Humphreys, IT CSV & SQA Manager, AmerisourceBergen
12:15 EST
Exhibitor Showroom and Grab & Go Lunch
12:45 -1:25 EST
Select Between Knowledge Exchange Sessions
Risk-based Spreadsheet Validation
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
Scripted vs. Unscripted Testing – Requirements Criticality Assessments
Ivan Soto, Senior Director Quality Assurance Validation, Sarepta Therapeutics
1:35 - 2:15 ET
Select Between Knowledge Exchange Sessions
Implementation and Validation of AI/ML Solutions
Rosalind Beasley, VP Digital Innovation, Dot Compliance
CSA Office Hours - Ask an Expert
Ken Shitamoto, Executive Director, Gilead Sciences
2:15 EST
Exhibitor Showroom and Afternoon Stretch
2:30 - 3:10 EST
Select Between Knowledge Exchange Sessions
Regulatory Considerations for Flexible Software Development
Chinmoy Roy, Senior Industry Consultant, ValGenesis, Inc.
Implementation of a Data Lifecycle / Management Maturity Model
Jonathon Thompson, Principal Consultant, CAI
3:20 - 4:00 EST
Select Between Knowledge Exchange Sessions
Implementing Corrective Action in Software Assurance Gaps
Kneat
Big Data is a Big Target – Security of Machine Learning Systems
Senthil Gurumoothi, Senior Industry Specialist, AWS Healthcare and Life Sciences; Pat Baird, Regulatory Head of Global Software Standards, Philips
4:00 EST
Close of Conference
Breaking News: FDA Releases Long-Awaited CSA Draft Guidance
COMPUTER SYSTEMS VALIDATION & SOFTWARE ASSURANCE UNIVERSITY
December 6th – 8th
With FDA’s heightened focus on Software Assurance and Data Integrity – Computer Systems Validation has taken on a new movement initiated by regulatory authorities. In fact, FDA has taken the lead with a proposed guidance on Computer Software Assurance and is asking firms to rethink their approach. With that said, the challenges remain high in our rapidly changing environment. In fact, inspectors continue to find serious findings such as – interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures.
Choose from Over 40+ Tutorials Addressing Today’s Top Challenges
COMPUTER SYSTEMS VALIDATION AND SOFTWARE ASSURANCE
- Critical Thinking and the CSA Movement – Rethink Your Approach to Traditional CSV
- Sustain and Build a Quality Culture in Today’s Realities
- Learn Machine Learning and AI Validation Strategies
- Modernize Risk Management in Software Testing
- Implement Risk Management in Cloud-based Platforms
- Design and Qualify Spreadsheets for Use in cGXP Environments
- Modernize the Periodic Review Process
- Enable Continuous Delivery of Software and Regulated Environments
- Validation Community of Practice – Effective Collaboration Across CSV Teams
- Managing Global Infrastructures and Data Centers
- Implement Effective System Configuration and Change Management Processes
- Validate Mobile Applications
- Create and Use a Checklist for Conducting a GAMP®5 Assessment
DON’T MISS THIS CRITICAL UPDATE
Stay Up To Speed with FDA’s Computer Software Assurance Initiative:
PLUS! A SPECIAL FOCUS ON
DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS
- The Interrelationship Between Data Integrity and CSA
- Build and Manage a Data Integrity Program
- Construct of a Program from the Ground Up
- Auditing Data Flows for Integrity and Compliance
- Implement an Effective Audit Trail Review Process
- Corrective Action in Data Integrity Lapses – Develop a Roadmap
- Implement a CAPA Process – What to Do When Things Go Wrong
Personnel in the Following Environments Should Attend:
- Validation
- Quality Assurance
- Engineering
- IT
- Data Integrity
- Quality Control
- Manufacturing Management
- Laboratory Management
- Regulatory Affairs
This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, paperless validation platforms, and validation consultant services.
TESTIMONIALS
“It exceeded my expectations, all the speakers are experienced people willing to share their knowledge, experience, and personal perspective.”CSI-DI Sr. Specialist, Baxter International
“This was a very informative conference. It gave me a lot of valuable information to take back to my organization and drive improvements.” – AQ & Validation Specialist, Wuxi AppTec
“It’s was a great knowledge-sharing platform. Each of the speakers were very informative and shared their experiences. Most of my questions were answered and gave a lot of clarity.”Computer System Validation Specialist, Catalent Pharma Solutions
