AGENDA

10:00 EST
Exhibitor Showroom and Virtual Platform Open House



10:15 EST
Chairperson’s Opening Remarks



10:30 - 11:00 EST
Understanding FDA’s CSA Guidance in the Context of Current Regulations and GAMP

Ken Shitamoto, Senior Director, IT and Senthil Gurumoorthi, Director, IT, Gilead Sciences



11:00 - 12:00 EST
Applying Computer Software Assurance to Data Integrity

Stephen J Cook, VP – Validation and Compliance and Khaled Moussally – EVP – Regulatory and Client Relations, Compliance Group, Inc.; Harsha Chulki: Head of Global IT Quality, Compliance & CSV - ICU Medical, In



12:15 - 12:45 EST
Exhibitor Showroom and Think Tank Sessions



1:00 - 1:30 EST
CSV and Regulatory Enforcement — Current and Future

Eric Henry, Senior Quality Systems and Compliance Advisor, FDA and Life Science Practice, King & Spalding



1:30 - 2:00 EST
Pharma 4.0 and Digitalization — Don't Be Left Behind

Jonathon Thompson, Principal Consultant, CAI



2:15 - 2:45 EST
Exhibitor Showroom and Think Tank Sessions



3:00 - 3:30 EST
How Much Validation is Enough?

Pritam Khade, Director, Global Quality Compliance, and Raechelle Ramondo, Executive Director, Global IT Quality, AbbVie; Shana Kinney, Associate Director, Validation, REGENXBIO



3:30 - 4:00 EST
Effective Risk Tools for CSV, DI and Automation

Kevin C. Martin, Senior Director and Managing Partner, Azzur Group



4:00 - 4:30 EST
Overcome Top Challenges to Program Implementation

Erik Muegge, M.S., Manager Operations Quality, Abbott Laboratories



4:30 EST
Game Night - Trivia Welcome Reception



7:00 EST
Exhibitor Showroom Opens



7:15 - 8:00 EST
Select Between Knowledge Exchange Sessions (1-3)



System Configuration and Change Management

Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care



Educate Personnel on CSV Execution

Robert J. Wherry, MSc, MS – Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals



DI Compliance for Legacy Software Applications

Sanjay Agrawal, President and CEO, CIMCON Software



8:15 - 9:45 EST
Select Between Knowledge Exchange Sessions (4-6)



A Critical Thinking and Risk-based Approach to CSV

Calvin Kim, Director Digital GxP Compliance Management, Bayer



Develop a Process for the End of a Computer System Life Cycle

John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI



Reducing Human Error for Compliance

Cindy Duhigg, Global Validation Steward, Alcon Laboratories



10:00 - 10:30 EST
Exhibitor Showroom and Think Tank Sessions



10:45 - 12:15 EST
Select Between Knowledge Exchange Sessions (7-9



Implementation Case Study – Overcome the Challenges of Paperless Implementation

Joseph Zec, Associate Director, R&D Data Systems Software Quality Assurance, Takeda Pharmaceuticals



Conduct a Part 11 Gap Analysis - Create a Checklist for Compliance

Carlos Pereira, Regional Manager, VTI Life Sciences



Create a Culture of Quality throughout Your Organization

Matthew LaPierre, Data Integrity Specialist, Industry Expert



12:30 - 1:15 EST
Select Between Knowledge Exchange Sessions (10-12)



SQA 101 - Introduction to Modern Testing in Preparation for CSA

Ken Shitamoto, Senior Director, IT and Senthil Gurumoorthi, Director, IT, Gilead Sciences



Validation of Mobile Applications

Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care



A Compliance Approach for Paper-based and Hybrid Systems

John Hannon, PE, CPIP, CBCP, Global Principal for Automation and IT, CAI



1:30 - 2:00 EST
Exhibitor Showroom and Think Tank Sessions



2:15 - 3:45 EST
Select Between Knowledge Exchange Sessions (13-15)



Planning Steps for Migrating CSV to CSA

Leslie Lighten-Humphreys, IT SQA and CSV Manager, AmerisourceBergan



Conduct Risk-based Impact Assessments

Eric Henry, Senior Quality Systems and Compliance Advisor, FDA and Life Science Practice, King & Spalding



Implement Process Mapping to Identify Data Integrity Gaps

William Honeck, Vice President, VTI Life Sciences



4:00 - 4:30 EST
Exhibitor Showroom and Think Tank Sessions



4:45 - 6:15 EST
Select Between Knowledge Exchange Sessions (16-18)



Senior Level Think Tank - Bring and Solve Your Challenge

Joseph Zec, Associate Director, R&D Data Systems Software Quality Assurance, Takeda Pharmaceuticals



Supplier Management – A Path to Build Trusted Partnerships

Pritam Khade, Director, Global Quality Compliance, and Vishal Kadakia, Senior QA Specialist, Global Quality, AbbVie



Success Factors for Developing a Corporate DI Program

Chinmoy Roy, Data Integrity and CSV SME, Industry Consultant, ValGenesis



6:15 EST
Close of Day Two



7:00 EST
Exhibitor Showroom Opens



7:15 - 8:00 EST
Select Between Knowledge Exchange Sessions (19-21)



Auditing Your Audit Trails – Are We Really Challenging the Status Quo?

April Bunje, Data Integrity Compliance Manager, Sanofi Pasteur



CyberSecurity — Addressing Malicious Threats in Our Modern Landscape

Christopher Robitaille, Chief Technology Officer, and Irving Bruckstein, Advisory Board, Azzur Solutions



Inspection Readiness - Conduct a Gap Analysis of Your Program

Robert J. Wherry, MSc, MS –Quality Compliance & Systems, RDQ Data Systems, Takeda Pharmaceuticals



8:15 - 9:45 EST
Select Between Knowledge Exchange Sessions (22-24)



Continuous Monitoring – Periodic Review and Revalidation of Computer Systems

Stephen J Cook, VP – Validation and Compliance, Khaled Moussally – EVP – Regulatory and Client Relations, Compliance Group, Inc.



Qualify SAAS, IAAS and Other Software Services

Steve Thompson, Director of Industry Solutions, ValGenesis



Critical Thinking - Rethinking Your Approach to Technology

April Bunje, Data Integrity Compliance Manager, Sanofi Pasteur



10:00 - 10:30 EST
Exhibitor Showroom and Think Tank Sessions



10:45 - 12:15 EST
Select Between Knowledge Exchange Sessions (25-27)



IT Infrastructure and Network Qualification

Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care



Risk-based Spreadsheet Validation — An Organized, Effective Approach for GxP Environments

Pritam Khade, Director, Global Quality Assurance, and Vishal Kadakia, Senior Specialist, Global Quality Assurance, AbbVie



Testing During Installation and Operational Qualification for Successful System Turnover

Dan Grill, Operations Manager & CSV Lead, Azzur Group



12:30 - 1:15 EST
Select Between Knowledge Exchange Sessions (28-30)



Develop a Cohesive Relationship Between QA and IT

Pritam Khade, Director, Global Quality Compliance, and Raechelle Ramondo, Executive Director, Global IT Quality, AbbVie; Ken Shitamoto, Senior Director, IT and Senthil Gurumoorthi, Director, IT, Gilead Sciences



GDPR Compliance Considerations for SAAS and Cloud Services

Holly Baldwin, Manager, Quality Validation, CSV, Sanofi Pasteur



Transitioning from Manual Processes to Process Automation

David W. Vincent, MPH, Ph.D., CEO, VTI Life Sciences



1:30 - 2:00 EST
Exhibitor Showroom and Think Tank Sessions



2:15 - 3:45 EST
Select Between Knowledge Exchange Sessions (31-33)



Validation Case Study – Using Mixed Reality Technology for C&Q of Pharmaceutical Equipment and Systems

Donncadh Nagle, Validation Lead, Eirchem Pharma & Researcher, TU Dublin



A Common Sense Approach to CSV and CSA - Implementing New Data Technolgy in the Device Environment

Teri Stokes, Ph.D., Director & Senior Consultant, GXP International



Validation by Design of a Manufacturing Automation System

Chinmoy Roy, Data Integrity and CSV SME, Industry Consultant, ValGenesis



4:00 - 5:30 EST
Select Between Knowledge Exchange Sessions (34-36)



Best-in-Class Documentation, SOPs, Templates and Checklists

Stephen J Cook, VP – Validation and Compliance, Compliance Group, Inc.



Instrument Qualification and Data Integrity Considerations

Loganathan Kumarasamy, Validation Consultant, Zifo RnD Solutions



Validation of Robotic Process Automation (RBA)

Steve Thompson, Director of Industry Solutions, ValGenesis



5:30 EST
Close of Conference



SPONSORS



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CAI

Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there. Website: https://commissioningagents.com




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Aventior

Aventior (www.aventior.ai) is an AI and Data Science company that is building data management and process automation solutions for the life sciences industry. Its CPV Automation (“CPV Auto”) platform uses AI-assisted technologies to process batch records that are either printed, scanned or hand-written. Through this automation, Aventior has reduced document processing times by over 75%. Some of the leading biotech firms use this platform to reduce their dependency on manual effort, decrease their data collection efforts, reduce errors and reduce the time to stay FDA compliant. Website: www.aventior.ai
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Azzur Group

A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive. Website: https://www.azzur.com/
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CompliancePath

CompliancePath is a Global IT Regulatory Consulting company with a focus in the Life Sciences and a specialization in the Software Assurance, IT Governance and Data Privacy verticals. Our near shore test centers in Europe and the America’s allow us to deliver Computer and Software Assurance projects in a virtual, risk based and budget conscious manner. We specialize in helping our customers achieve and maintain ISO27001, SOC1/2/3, HITRUST and related certifications. Further, we help software companies in the Life Science commercialize their products, having brought sustainable agile GAMP5 based development processes all the way through product realization. Our 21 CFR Part 11 compliant Life Science platform Promedim, supports clinical trials, GDPR, and remote field service, site inspection and training activities. We are actively involved in GAMP, the Scottish Life Science Association and were signatories on the Turnpike agreement that solidified and increased collaboration between Life Science associations in the UK and US. Website: www.compliancepath.com
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H&A Scientific

H&A Scientific, Inc. is a scientific software development firm specializing in pharmaceutical industry support. We develop, validate, and market quality computing systems for scientific data acquisition, processing, and data management. We have been creating programs for the laboratory since 1992. Our products have been designed under our Quality System to adhere to the current GAMP guidelines. We develop Quality Software products based on the needs of pharmaceutical companies subject to the constraints and compliance of the Food and Drug Administration (FDA). Our flagship product, SLIM, is a commercial off-the-shelf solution for total management of a company's drug stability program. Website: http://www.hascientific.com/en/




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CIMCON Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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Compliance Group

Compliance Group is a trusted Global Quality / Compliance consulting firm with 15+ years of experience serving GxP regulated industries. Our mission is to improve client outcomes through innovative solutions that enhance product quality and regulatory compliance while reducing cost and time to market. Our leadership team includes experts who work closely with the FDA and members of highly recognized organizations, like ISPE GAMP. Their expertise and training is included in every client's engagement and is reflected in our client testimonials. Website: https://www.complianceg.com/
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QACV

QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization. Website: http://www.qacvconsulting.com/

This fall, FDA plans to release a draft guidance on Computer Software Assurance! Are you prepared?


Attend Virtually or in Philadelphia, PA!

To this day, CSV and Data Integrity challenges remain high in our rapidly changing environment. In fact, FDA and other regulators continue to find serious findings including; having 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. KENX is pleased to announce that our comprehensive CSV & DI Congress is headed to Philadelphia, PA, and showcases the protocols, methodology and actions necessary to avoid regulatory action.



Choose from Over 40+ Tutorials Addressing Today’s Top Challenges


COMPUTER SYSTEMS AND SOFTWARE VALIDATION

  • Develop a Compliant-Winning Strategy to Migrate Electronic Records
  • Understand FDA’s CSA Expectations and Proposed Draft
  • Implement Process Mapping for IT Infrastructures
  • Learn Machine Learning and AI Validation Techniques
  • Conduct Risk-Based Impact Assessments and Continuous Monitoring
  • Understand Pharma 4.0 and the Impact of Digitalization and IoT to CSV
  • Implement Risk Management in Cloud-Based Exchange Systems
  • Modernize the Periodic Review Process
  • Overcome MS Excel Spreadsheet Validation
  • Validate Cloud-hosted Systems and Network Infrastructures

DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS

  • Conduct a Thorough and Accurate Gap Assessment
  • Identify Gaps and Investigate Root Causes of Lapses
  • Construct of a Program from the Ground Up
  • Understand the Impact of Human Performance – Transform the Culture
  • Implement an Effective Audit Trail Review Process
  • Conduct a Risk-based Remediation
  • Implement a CAPA Process – What to Do When Things Go Wrong
  • Manage Corporate Challenges and Define Clear Roles and Responsibilities
  • Learn How to Effectively Document Risks

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, data collection and statistics.


Pricing & Registration




For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.