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
Faculty
AGENDA
Handling product complaints and recalls are (and have always been) a regulatory hot issue for both the FDA and other global regulators. In fact, there have been a flurry of Warning Letters on handling complaints in the last few years and the FDA has recently issued two guidance documents on product recalls. The time has never been greater to ensure you have established best in class procedures for receiving, reviewing, and evaluating complaints. Moreover, from Covid and beyond it is essential you have a risk mitigation plan for product recalls to ensure you can handle today’s supply chain challenges in an instant. Come and attend KENX’s Handling Product Complaints and Product Recalls forum, network with your peers and ensure you have up-to-the-minute modern processes in place to master these critical areas.
EARLY BIRD PRICING ENDS FRIDAY, OCTOBER 21
PRODUCT COMPLAINTS HIGHLIGHTS:
Initiating, Performing and Documenting a Complaint Investigation
How to Use Risk-based Decision Making in Handling Complaints
Automate Field Alerts and Actions Processes to Streamline Identification, Reporting, and Analysis
End-to-End Methods to De-Escalate Product Complaints
Utilize Data Analytics / AI to Obtain Actionable Insights and Streamline Processes
Building an Effective and Customer-Centric Complaints Team
Learn How to Effectively Utilize CAPA in the Complaint Handling Process
Critical Steps to Successfully Adhere to the FDA Incident Timeline Requirements
Using Social Media as a Tool to Gather Information about Produce Complaints and Adverse Events
Developing Robust Adverse Events Risk Management Processes and Execution Strategies
Manage Adverse Events Incidents by Reducing Risks and Optimizing Reporting Processes
PRODUCT RECALLS HIGHLIGHTS:
Review FDA’s Recent Voluntary Recalls (March ’22) and Recalls (March ’20) Final Guidance
Understand the Critical Steps to Initiate a Recall and Design an Effective Withdrawal Strategy
Learn the Key Factors to Determine Product Recall or Removal Justification
Prepare Impactful Product Recall and Removals Communication Strategies
Effective Strategies to Ensure Product Recall Tracking and Reporting Accuracy
Implement an Effective CAPA Management System
Use Risk Assessment and Mitigation for Recall Decision Making
Global Recalls – Prepare a Contingency Plan for a Large-Scale Event
Write Regulatory Compliant and Effective Public Notices and Cross-Functional Internal Communications
Strategies for Product Disposal, Effectiveness Checks and Concluding a Product Recall
Identify, Report, and Risk Assessment of Invisible Defects
Who Should Attend
- Quality Assurance/Quality Control
- Regulatory Affairs
- Quality Risk Management
- Corporate Risk Management
- Legal and Compliance Officers
- Operations, Production, and Manufacturing Directors and Managers
- General/Corporate Counsel
- Medical Affairs
- Medical Communications
- Media and Public Relations
- Complaint Handling Management
- Recall Management
- Quality Engineers
- Process Engineers
- Supply Chain
Faculty
Validation & GMP
University Canada
AGENDA
7:00 ET
Exhibitor Showroom Opens and Lite Breakfast
7:45 - 8:35 ET
Select Between Knowledge Exchange Sessions
REGULATIONS
Compliance Intelligence - Navigating the Maze of New Validation and GMP Regulations
Khaled Moussally, EVP Clients & Regulatory Relations, Compliance Group
8:45 - 10:15 ET
Select Between Knowledge Exchange Sessions
PROCESS VALIDATION
Risk-based Process Validation - Program Implementation Case Study
Raul Soto, Senior Principal Quality Software Engineer, Johnson & Johnson Vision Care
QUALITY METRICS
Quality Metrics Think Tank - Insight from the Front Line
Dori Gonzalez-Acevedo, CEO, ProcellaRX
10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 ET
Select Between Knowledge Exchange Sessions
EQUIPMENT QUALIFICATION
Commissioning & Qualification - Risk-based IQ / OQ / PQ
Abhishek Garg, CAPM, CQV Project Leader, IPS
Annex 1 in The Age of Digitization: Reimagining Contamination Control
Parsa Famili, President and CEO, Novatek
11:35 - 12:15 ET
Select Between Knowledge Exchange Sessions
VALIDATION STATISTICS
Process Validation Statistics for Non-statisticians
Cindy Duhigg, Global Process Validation Steward, Alcon
SUPPLIER AUDITS
Risk-based Supplier Partnering and Auditing – During the Pandemic and Beyond
Kim Huynh-Ba, Managing Director, Pharmalytik Consulting; Adjunct Faculty, Regulatory Compliance, Illinois Institute of Technology (IIT)
12:15 ET
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 ET
Select Between Knowledge Exchange Sessions
VALIDATION MASTER PLAN
Developing a High Quality Validation Master Plan (VMP) for Regulators
Megan Gaudet, CQV Project Lead, IPS
DEVIATIONS & CAPA
Minimize Deviations in Quality Systems and Implement Effective Corrective Actions
Dr. Dominique P. Thierry, Principal Consultant, CAI
1:35 -3:05 ET
Select Between Knowledge Exchange Sessions
CSV & SOFTWARE ASSURANCE
Modernize Software Validation - Align with CSA, Risk Assessments, and Critical Thinking
"Esra Guven, Associate Director, GIS- Computer Systems Validation, Apotex Debbie Chenier, Computer Systems Validation Team Lead, Apotex "
QUALITY SYSTEM MANAGEMENT
Learn How to Evaluate Your Quality System Effectiveness
Raul Soto, Senior Principal Quality Software Engineer, Johnson & Johnson Vision Care
3:05 ET
Exhibitor Showroom and Afternoon Stretch
3:30 - 4:10 ET
Select Between Knowledge Exchange Sessions
CONTINOUS VALIDATION
Continuous Process Validation and Holistic Control Strategy: Thinking Beyond CPP-Based Critical Aspects
Chip Bennett, Associate Director Global C&Q, CAI
CHANGE CONTROL
Risk-based Change Control - Program Development, Impact Assessments and Audits
Adnan Abosh, Associate Director, Equipment & Facility Qualification, Apotex
4:20 - 5:00 PT
Select Between Knowledge Exchange Sessions
PAPERLESS VALIDATION
Case Study: Starting the Paperless Journey
"Adnan Abosh , Associate Director, Equipment & Facility Qualification, Apotex Josh Centner, Sales Director, Kneat "
UTILITY QUALIFICATION
Environmental Monitoring - HVAC and Water System Qualification
To Be Announced
5:00 ET
Close of Day One and Networking Cocktail Reception
7:15 ET
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 ET
Select Between Knowledge Exchange Sessions
DOCUMENTATION
fDA's Quality Metrics Movement -- Measure Manufacturing Process Performance – Equipment Effectiveness - Right First Time Rates
"Esra Guven, Associate Director, GIS- Computer Systems Validation, Apotex Debbie Chernier, Computer Systems Validation Team Lead, Apotex "
DATA INTEGRITY
"Data Integrity Governance - Development, Implementation, and Maintenance"
Carlos L Pereira, Regional Manager of US Midwest, and Canada, VTI Life Sciences
8:45 - 9:25 ET
Select Between Knowledge Exchange Sessions
CLEANING VALIDATION
Implement a Risk-based Cleaning Validation Program
David W. Vincent, Chief Executive Officer (CEO),/B.Sc.,MPH, PhD, VTI
RISK MANAGEMENT
A Practical, Resource Effective Approach to Risk Management - Common and Customized Tools
Ana Margarida Ventura, Quality Risk Management Tech Lead, 4TE
10:15 - 10:45 ET
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 ET
Select Between Knowledge Exchange Sessions
WOMEN LEADNING VALIDATION
Panel Discussion: Authentic Leadership and Leaning into Leadership
Dori Gonzalez-Acevedo, CEO, ProcellaRX
RISK MANAGEMENT
Case Study - Optimization of Cleaning to Reduce Water Consumption and Time while Increasing Production Capacity
Kalpesh Patel, Chief Operating Officer, Compliance Associates
11:35 - 12:15 ET
Select Between Knowledge Exchange Sessions
CLEANING OPTIMIZATION
Case Study - Optimization of Cleaning to Reduce Water Consumption Time
Sarma R. Donepudi, Sr. Quality and Compliance Associate, Compliance Associates
AUDITS & INSPECTIONS
Design Your Fit-for-Purpose Audit Checklist
Kim Huynh-Ba, Managing Director, Pharmalytik Consulting; Adjunct Faculty, Regulatory Compliance, Illinois Institute of Technology (IIT)
12:15 PT
Exhibitor Showroom and Grab & Go Lunch
12:45 - 1:25 PT
Select Between Knowledge Exchange Sessions
PAPERLESS VALDIATION
Case Study: Starting the Paperless Journey
Emmanuel Cansino, Sr. Director- Global Indsutry Solutions, ValGenesis
AUDITS & INSPECTIONS
10,000” View of “Effective Stability Testing Programs as Part of the QMS
Geoff Carr, Director, Analytical Development, Thermofisher Patheon
1:35 - 2:15 ET
Select Between Knowledge Exchange Sessions
PROCESS VALIDATION
Analytical Testing for Process Validation
Cindy Duhigg, Global Process Validation Steward, Alcon
QUALITY CULTURE
Quality Culture - Understand Human Impact in Your QMS
Lisa Hawkins, Principal Consultant, CAI
2:25 - 3:05 PT
Select Between Knowledge Exchange Sessions
CLEANING VALIDATION
Cleaning Validation Hot Topics - Stainless Steel Equipment, Visual Inspection and Equipment Grouping
Sunil Patel, Director Center of Excellence, ValGenesis
LABORATORY CONTROLS
Laboratory Controls - Ensure Cleanliness, Control, Accuracy, Quality, and Safety
Michael Lund, Program Manager, Hyde Engineering + Consulting
3:05 PT
Exhibitor Showroom and Afternoon Stretch
3:30 - 4:15 PT
Select Between Knowledge Exchange Sessions
TECH TRANSFER
Overcome Process Validation Challenges for Technology Transfer
Deven Sandhu, PhD, MBA, ICD.D, Management Consultant, Biotherapeutics
SUPPLY CHAIN
Case Study- Optimizing Risk Assessment Using Software
Prannoy Kothari, Senior Product Manager, Veeva
VALIDATION UNIVERSITY COMES TO CANADA!
November 7 – 8, 2022
Attend in Toronto or Virtually!
Join KENX for Validation & GMP University series tailored specifically for those manufacturing drugs, biologics, and medical devices in Canada. The event provides hands-on training for Quality, Validation, Engineering and Regulatory Affairs professionals. Participants create-their-own-experience by choosing from over 30 tutorials offering innovative, modern strategies for Validation and Quality Systems Management. Whether you’re interested in best practices for process, cleaning, and computer validations, or quality metrics, change control and risk management, this conference is for you! Come join the fun and learn from the best SMEs our industry has to offer and enrich your professional development in these critical environments.
30+ tutorials overflowing with rich content and tangible takeaways, including:
- Navigate the maze of validation regulatory guidance – A systematic approach to knowledge management
- Design a risk-based IQ, OQ, and PQ approach for facility commissioning & equipment qualification
- Modernize software validation – Align with CSA, risk assessments, and critical thinking
- Change Control – Mitigate risk when making changes to validated systems
- Continued Process Verification – Maintaining equipment and processes in a validated state
- Analytical testing for process validation
- Risk-based process validation – Program implementation case study
- QRM – Conducting a validation risk assessment
- Qualify critical utility systems – HVAC, Water and Gas
- Medical device validation & verification program implementation
- Build a Data Integrity program from the ground up
- Developing a high-quality Validation Master Plan (VMP) for regulators
- Risk-based supplier partnering and auditing – During the Pandemic and Beyond
Personnel In The Following Environments Should Attend:
- Validation
- QA/QC
- Engineering
- C&Q
- Regulatory and Compliance
- Facility Management
- Manufacturing
- Laboratory
This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.
Faculty
AGENDA
9:00 IST
Exhibitor Showroom and Virtual Platform Open House
9:45 IST
Chairman's Opening Remarks
10:00 - 11:00 IST
FDA Case for Quality (CfQ) Initiatives and Flurry of Released Guidance(s) – VIP, CSA, GAMP 5 2nd EDITION, and Make CAPA Cool
Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group; Francisco (Cisco) Vicenty, Case for Quality Program Manager, U.S. FDA (Invited); Joseph Sapiente, Vice President, Clinical Science & Technology, Medical Device Innovation Consortium (MDIC); Damien McPhillips, Director, Global Software Quality & Digital Health and Ray Murphy, Fellow Engineer Global Software Quality, Boston Scientific
11:00 - 11:30 IST
Exhibitor Showroom and Refreshment Break
11:30 - 12:00 IST
Computer Software Assurance Journey (CSA) - Challenges, Breakthroughs and Measures of Success
Calvin Kim, Head of Quality Systems and Validation, Samsung Biologics (Invited)
12:00 - 12:30 IST
Navigate the Maze of Validation Regulatory Guidance - A Systematic Approach to Knowledge Management
Connie Hetzler, Global Head – Validation, Alcon Laboratories
12:30 IST
Networking Luncheon
13:30 - 14:00 IST
Compliance Trends, Metrics, and the Cost of Non-quality and Validation
Karen Ginsbury, MSc, BPharma, CEO, PCI Pharmaceutical Consulting Israel
14:00 -14:30 IST
Critical Thinking in Practice - Rethinking Your Approach to Technology
Damien McPhillips, Director, Global Software Quality & Digital Health and Ray Murphy, Fellow Engineer Global Software Quality, Boston Scientific
14:30 - 15:00 IST
Agile Software Development and Validation
Stefan Münch, Business Director Validation, Körber Pharma Consulting
15:00 - 15:30 IST
Exhibitor Showroom and Refreshment Break
15:30 - 16:00 IST
Annex 1 in The Age of Digitization - Reimagining Contamination Control
Parsa Famili, President and CEO, and Stephen Smith, Commercial Manager, Novatek International
16:00 - 16:30 IST
Shaping the Future of Manufacturing Quality – From Quality Metrics to Quality Management Maturity and Beyond
Nuala Calnan, Ph.D., CEO, QRMi
16:30 - 17:00 IST
Quality and Validation's Role in Speed to Patient
ent Alice Redmond, Chief Strategy Officer, CAI
17:00 IST
Networking Welcome Reception
7:15 IST
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 IST
Select Between Knowledge Exchange Sessions
Process Validation
Understand Documentation Requirements for Validation - Best in Class Approaches
Connie Hetzler, Global Head – Validation, Alcon Laboratories
Computer Systems & Software Validation
Create and Use a Checklist for Conducting a GAMP® 5 Assessment
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
QMS - Metrics
FDA's Quality Metrics Movement - What You Need to Know to Get Started
Karen Ginsbury, MSc, Bpharm, PCI Pharmaceutical Consulting Israel
8:45 - 10:15 IST
Select Between Knowledge Exchange Sessions
Process Validation
Risk-based Process Validation - Program Implementation Case Study
Jorge Cordero, Validation Manager, Bausch + Lomb
Computer Systems & Software Validation
Build a Modern Risk-Based CSV Program - An End to End Lifecycle Model
Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group
QMS - Metrics
Build a Change Control Programme from the Ground Up
Matthew Jackson, Validation Manager, Torbay Pharmaceuticals
10:15 - 10:45 IST
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 IST
Select Between Knowledge Exchange Sessions
CQV Project Management
Project Management Intelligence for Delivering Pharmaceutical CQV Capital Projects
David Egan, Group Head, PM Group
Computer Systems & Software Validation
Conduct Risk-based Spreadsheet Validations
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
QMS - Change Control
Change Control - Mitigate Risk when Making Changes to Validated Systems
Connie Hetzler, Global Head – Validation, Alcon Laboratories
11:35 - 12:15 IST
Select Between Knowledge Exchange Sessions
Process Validation
Developing a High Quality Validation Master Plan (VMP) for Regulators
Jorge Cordero, Validation Manager, Bausch + Lomb
Computer Systems & Software Validation
Conducting Periodic Reviews of Computer Systems and Software Platforms
Milan Kalinic, Associate Director, Technical Services, Alexion Pharmaceuticals
Process Performance
Bridging the Gap from Project to Operations – The Pivotal Role of the System Owner
Aaron Roth, Associate Director, Global C&Q, Harry Benson, Director, Human Performance, CAI
12:15 IST
Exhibitor Showroom and Grab & Go Lunch
12:45 - 13:25 IST
Select Between Knowledge Exchange Sessions
Process Validation - Visual Inspection
Learn How to Validate Visual Inspection Systems
Jorge Cordero, Validation Manager, Bausch + Lomb
Computer Systems & Software Validation
When X becomes Machine Learning (ML): GMLP – Validating Artificial Intelligence (AI) for Automated Visual Inspection (AVI)
Stefan Münch, Business Director Validation, Körber Pharma Consulting
Statistics in Validation
Moving to Objective, Data-Driven Decisions – The Who, What, When, Where, Why, and How of Statistics
Tara Scherder, Principal, SynoloStats LLC
13:35 - 15:05 IST
Select Between Knowledge Exchange Sessions
Process Validation
Continuous Process Validation and Holistic Control Strategy - Thinking Beyond CPP-Based Critical Aspects
Chip Bennett, Associate Director Global C&Q, CAI
Computer Systems & Software Validation
CSV Hot Topics - IT Infrastructure, SaaS, and Mobile Device Qualifications
Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care
Statistics in Validation
Using Statistics as a Risk Tool throughout the Process Validation Lifecycle
Tara Scherder, Principal, SynoloStats LLC
15:05 IST
Exhibitor Showroom and Refreshment Break
15:30 - 16:15 IST
Select Between Knowledge Exchange Sessions
Process Validation
Ensuring Your Validation Programme is Inspection Ready
Milan Kalinic, Associate Director, Technical Services, Alexion Pharmaceuticals
Computer Systems & Software Validation
Modernise Risk Assessments of Software Platforms
Louie Rayal, Senior Director, IT Quality Regulatory and Compliance, Abbott
Statistics in Validation
Develop a Control Strategy Using Design of Experiments (DOE)
Tara Scherder, Principal, SynoloStats LLC
16:30 - 17:15 IST
Select Between Knowledge Exchange Sessions
Process Validation
Validation Cost Management - Ensure Quality while Reducing Cost
Phil Jarvis, Director Integrated C&Q and Paperless Strategy, Veqtor Solutions
Statistics in Validation
Use of Modern Statistical Tools for Accelerated Development & Novel Therapies
Tara Scherder, Principal, SynoloStats LLC
17:15 IST
Close of Day Two
7:15 IST
Exhibitor Showroom Opens and Lite Breakfast
7:55 - 8:35 IST
Select Between Knowledge Exchange Sessions
Process Validation
Knowledge Management in Validation - Using Technology for Continuous Improvement
Donncadh Nagle, CQV Lead, Jacobs Engineering, and Lecturer, TU Dublin
Cleaning Validation
Cleaning Cycle Efficiency and Environmental Footprint – How Much Can You Save?
Kenneth Pierce, Technical SME, Cleaning Science & Cleaning Validation, Hyde Engineering
GxP TRAINING
How Do You Know? Evaluating Effectiveness of a GxP Training Programme
Danielle Duran, Director, GxP Compliance and Training, Aimmune Therapeutics
8:45 - 10:15 IST
Select Between Knowledge Exchange Sessions
Process Validation
Develop a Strategy to Transition to Paperless Validation C&Q
Phil Jarvis, Director Integrated C&Q and Paperless Strategy, Veqtor Solutions
Cleaning Validation
Cleaning Validation Programme Design - A Risk-based Lifecycle Approach
Kenneth Pierce, Technical SME, Cleaning Science & Cleaning Validation, Hyde Engineering
Data Integrity
Building and Managing a Data Integrity Programme
To Be Announced
10:15 - 10:45 IST
Exhibitor Showroom and Refreshment Break
10:45 - 11:25 IST
Select Between Knowledge Exchange Sessions
PROCESS PERFORMANCE
Measure Manufacturing Process Performance – Process Capability/Performance, Lot Acceptance Rate (LAR), Right-First-Time Rate, Lot Release Cycle Time
Karen Ginsbury, MSc, Bpharm, PCI Pharmaceutical Consulting Israel
CLEANING VALIDATION
Cleaning Validation Hot Topics
Hyde Engineering + Consulting
DATA INTEGRITY
Strategies to Minimise Deviations and Implement Effective Corrective Actions
Matthew LaPierre, Data Integrity Lead, Jackson Scott Consulting
11:35 - 12:15 IST
Select Between Knowledge Exchange Sessions
UTILITY QUALIFICATION
SOP’s - Not Just for the What
Nathan Pofahl, Associate Director GxP Learning, Ultragenyx
SUPPLIER AUDITS
Risk-based Supplier Partnering and Auditing – During the Pandemic and Beyond
Kim Huynh-Ba, Managing Director, Pharmalytik Consulting
DATA INTEGRITY
Data Process Mapping - Utilize an Innovative Tool to Manage Data Integrity
Darragh Boyle, Process Engineer, Kneat
12:15 IST
Exhibitor Showroom and Grab & Go Lunch
12:45 - 13:25 IST
Select Between Knowledge Exchange Sessions
GxP Training
Incorporating Effective SOPs in Training Programs – It’s Not Just for the What
Nathan Pofahl, Associate Director GxP Learning, Ultragenyx
QMS - Risk Management
Risk-Based Thinking – Maximise your ROI on Risk Assessments – A Practical, Resource Effective Approach to Risk Management
Karen Ginsbury, MSc, Bpharm, PCI Pharmaceutical Consulting Israel
Data Integrity
Develop a Quality Culture that Minimises Human Error and Data Integrity Lapses
Kneat
13:35 - 14:15 IST
Select Between Knowledge Exchange Sessions
Process Validation - SUS
Validation Strategies for Single Use Systems
David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
QMS - Risk Management
Conducting Impactful Risk Assessments throughout the QMS - What Tool, Where, and How
4TE, a ValGenesis Company
Data Integrity
Take a Risk-based Approach to Audit Trail Reviews
Matthew LaPierre, Data Integrity Lead, Jackson Scott Consulting
14:25 - 15:05 IST
Select Between Knowledge Exchange Sessions
Process Validation - IQ/OQ/PQ
Risk-Based Equipment Qualification - Shifting the Paradigm from Leveraging to Integrated
Chip Bennett, Associate Director Global C&Q, CAI
QMS - Risk Management
How to Use Risk Throughout the Process Validation Lifecycle
Matthew Jackson, Validation Manager, Torbay Pharmaceuticals
AR/VR Validation
Transforming Validation - The Effect of Automated and Virtual Reality
Donncadh Nagle, CQV Lead, Jacobs Engineering, and Lecturer, TU Dublin
15:05 IST
Exhibitor Showroom and Afternoon Stretch
15:30 - 16:15 IST
Select Between Knowledge Exchange Sessions
Process Validation - Tech Transfer
Implementing a Successful Technology Transfer to Ensure Fit-for-Purpose
Kim Huynh-Ba, Managing Director, Pharmalytik Consulting
QMS - Audits & Inspections
Design Your Custom Audit Checklist
David W. Vincent, MPH, Ph.D., Chief Scientific Officer, VTI Life Sciences
16:15 IST
Close of Day Three
VALIDATION UNIVERSITY COMES TO EUROPE!
Attend Virtually or in Dublin, Ireland!
Knowledge Exchange Network (KENX) is extremely excited to announce Validation & GMP University is returning to Europe this November! This is Europe’s leading validation and QMS event. Do not miss this opportunity to network with leading experts and like-minded colleagues leading the charge for best practices in validating processes, cleaning, equipment, facilities, utilities, quality systems & metrics, change control, risk management, inspections and so much more! Participants can create their own experience by choosing from over fifty tutorials and benefit from the wealth of knowledge that will have immediate impact on their professional development and organizations.
Choose from 50 Tutorials Overflowing with Rich Content and Tangible Takeaways, Including:
Process Validation
- Master Risk-based, 3-Stage Process Validation
- How to Drive a Risk-based IQ, OQ, and PQ Approach
- Critical Utility Qualification – HVAC, Water and Process Gasses
Cleaning Validation
- Establish Cleaning Residue Limits and Acceptance Criteria
- Learn How to Validate Visual Inspection Systems
- Hot Topics in Cleaning – Stainless Steel Equipment Maintenance and Air Liquid Interface Rings
Computer System Validation & Software Assurance
- Modernize Software Validation and Risk Assessments
- Tips for Transitioning Current CSV Program to Align with FDA’s Computer Software Assurance Guidance
- Critical Thinking and the CSA Movement – Rethinking Your Approach to Technology
Data Integrity Compliance
- Building and Managing a Data Integrity Program
- Data Process Mapping – Utilize an Innovative Tool to Manage Data Integrity
- Develop a Quality Culture that Minimizes Human Error and Data Integrity Lapses
Quality Metrics & Systems Management
- FDA’s Quality Metrics Movement – What You Need to Know to Get Started
- SOPs – Writing Quality Procedures that Survive the Lifecycle
- How to Increase and Achieve Right First Time Rates
Change Control & Risk Management
- Integrate Risk Management into Change Control Procedures
- Risk-Based Thinking – Maximize your ROI on Risk Assessments – A Practical, Resource Effective Approach to Risk Management
- Conducting Impact Assessments as Part of Change Control
Personnel In The Following Environments Should Attend:
- Validation
- QA/QC
- Engineering
- C&Q
- Regulatory and Compliance
- Facility Management
- Manufacturing
- Laboratory
This event is also appropriate for business development and sales managers that offer innovative solutions for quality, validation and engineering professionals in the life science environment.
Faculty
31 E Kings Highway
2nd Floor
Haddonfield, NJ 08033
Email: info@kenx.org
Phone: 858 649 3251