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AGENDA
Day 1
| Time | Session Title | Speaker | Session Description |
|---|---|---|---|
| 11:45 AM – 12:45 PM | Registration – Coffee & Tea | ||
| 12:45 – 1:00 PM | Chairperson’s Opening Remarks | ||
| 1:15 – 2:15 PM | Panel Discussion: Aligning to GMP Regulatory Developments & Updates – EU vs. FDA vs. WHO | Moderator: Khaled Moussally, Executive Vice President, Corporate Development & Operations Compliance Group Panelists: Sheba Zaman, Head of Product Specialists and Training Services, Novatek International Katelyn Staub-Zamperini, Senior Operations Officer, ORA, FDA Gaurav Walia, Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner, PQE Group |
|
| 2:15 – 3:00 PM | FDA Inspection & Audit Readiness | Andrea Roether, Senior Director of Global Quality Creation Technologies | Topics: • FDA inspection expectations • FDA inspection timelines • FDA readiness – what does that mean? • Scope of readiness activities • Project management approach to readiness activities • Inspection management – front/back room • Inspection closure Takeaway Tools: |
| 3:00 – 3:30 PM | Networking Refreshment Break and Exhibit Showroom | ||
| 3:30 – 4:00 PM | Understanding Human Behavior and Quality Culture in Validation and GMP Operations |
Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory Precision for Medicine | |
| 4:00 – 4:30 PM | The Impact of A.I. in Your GMP Processes | Sheba Zaman, Head of Product Specialists and Training Services, Novatek International | |
| 4:30 – 5:00 PM | FDA & EU Guidance in Quality Risk Management | Emily Dickinson, MS, ASQ CQA, Associate Director Quality Assurance Linical Americas | |
| 5:00 PM | Networking Cocktail Reception |
Day 2
| Time | Session Title | Speaker | Session Description |
|---|---|---|---|
| 8:00 – 9:00 AM | Exhibitor Showroom Opens and Lite Breakfast | ||
| 9:10 – 10:00 AM | Select Between Knowledge Exchange Sessions | ||
| 9:10 – 10:00 AM | Strategies for Streamlined Change Control Processes | Raul Soto, Senior Manager MedTech Supply Chain Johnson & Johnson | |
| 9:10 – 10:00 AM | FDA, EU and ICH Requirements and Expectations for Quality Reviews | Heeda Jafarishahvarlu | |
| 9:10 – 10:00 AM | Risk Management & Continuous Improvement | Cindy Duhigg, Global Process Validation Steward Alcon | |
| 10:05 – 10:50 AM | Select Between Knowledge Exchange Sessions | ||
| 10:05 – 10:50 AM | FDA’s Requirement & the Quality Metric Program Update | Emily Dickinson, MS, ASQ CQA, Associate Director Quality Assurance Linical Americas | |
| 10:05 – 10:50 AM | Assessing Your QMS Effectiveness | Chris Wubbolt, BS, MS, Consultant QACV Consulting | |
| 10:05 – 10:50 AM | FDA Insights: Navigating GMP Compliance in Today’s Regulatory Landscape | Katelyn Staub-Zamperini, Senior Operations Officer ORA, FDA | |
| 11:00 – 12:00 PM | Speed Networking & Training | ||
| 12:00 – 1:00 PM | Lunch and Learn | ||
| 1:10 – 1:50 PM | Select Between Knowledge Exchange Sessions | ||
| 1:10 – 1:50 PM | Quality Metrics & Technology: Using Digital Tools for Enhanced Process and Product Monitoring | Saurabh Joshi, Director-Solution Engineering Valgenesis | |
| 1:10 – 1:50 PM | Digital Quality Journey – What It Is & What It Means for Your Organization | Rahul Songire, Vice President – Central Quality Zydus Lifesciences Limited | |
| 1:10 – 1:50 PM | Managing Changes to CSV & GMP Documentation to Maintain Compliance | Aditya Balaji, Computer System Validation (CSV) Supervisor Grand River Aseptic Manufacturing | |
| 2:00 – 2:40 PM | Select Between Knowledge Exchange Sessions | ||
| 2:00 – 2:40 PM | Effective Use of Change Control Methodologies for Lean Documentation | Vivekram Apparsundaram, Head of Commissioning, Qualification and Validation, North America Zifo Technologies Inc. | Topcs: • Role of change control in maintaining the integrity, quality, and compliance of validated systems and instruments • Principles of lean documentation • Strategies for integrating change control processes with lean documentation principles • Risk-based change management and associated documentation • Levers of cohort validation (family approach) in instruments space Takeaway Tools: |
| 2:00 – 2:40 PM | Data Integrity & Data Governance | Paul Lopolito, President & CEO Comply Guru | Topics: • Data Integrity Principles (ALCOA+) • Data Governance Framework • Data Lifecycle Management • Data Risk Assessment and Mitigation • Data Integrity Culture and Training • Regulatory Expectations and Compliance • Case Studies and Best Practices |
| 2:00 – 2:40 PM | Risk Management the GAMP® 5 Way | Aditya Balaji, Computer System Validation (CSV) Supervisor Grand River Aseptic Manufacturing | |
| 2:50 – 3:30 PM | Select Between Knowledge Exchange Sessions | ||
| 2:50 – 3:30 PM | Creating and Maintaining a GMP Quality System | Heeda Jafarishahvarlu | |
| 2:50 – 3:30 PM | Building a Quality Culture for Use of AI/ML in GMP Environment | Loganathan Kumarasamy, Head – Scientific Informatics & Compliance Services Zifo Technologies Inc. | Topics: • AI/ML Use Cases in GMP Environment • Defining AI/ML vision with the organization • Understanding the various personas of AI/ML usage • Building a Quality Management System for effective and secure use of AI/ML • Setting up of Required Policies / Procedures and WIs when utilizing AI/ML in GMP Environment • Training and Continuous Improvements |
| 2:50 – 3:30 PM | Developing a Contamination Control Strategy (CCS): Focused on Personnel Practices and Cleaning and Disinfection | Jim Polarine Jr. MA., Senior Technical Service Manager STERIS Corporation | |
| 3:30 – 3:40 PM | Exhibitor Showroom and Refreshment Break | ||
| 3:50 – 4:30 PM | Select Between Knowledge Exchange Sessions | ||
| 3:50 – 4:30 PM | Understanding GMP Requirements For Change Control | David W. Vincent CSO/ B.Sc., MPH, P.hD., Chief Scientific Officer VTI Life Sciences | |
| 3:50 – 4:30 PM | FDA Pre-Approval Inspection Training | Compliance Group | |
| 3:50 – 4:30 PM | Quality Risk Management – Top Five Most Common Errors & How to Avoid Them | Joe Ault, Senior Product Marketing Manager, Software Thermo Fisher Scientific | |
| 4:40 – 5:20 PM | Select Between Knowledge Exchange Sessions | ||
| 4:40 – 5:20 PM | Change Management 2.0: Modern Approaches to Change Control for GMP Compliance | Compliance Group | |
| 4:40 – 5:20 PM | Optimizing Your Audit Program | Dawn Marshall (Tavalsky), Global External Manufacturing – Quality Sanofi |
Day 3
| Time | Session Title | Speaker | Session Description |
|---|---|---|---|
| Start of day 3 | |||
| 8:00 – 9:00 AM | Exhibitor Showroom Opens and Lite Breakfast | ||
| 9:10 – 9:50 AM | Select Between Knowledge Exchange Sessions | ||
| 9:10 – 9:50 AM | How to Utilize Quality Metrics to Drive Continuous Improvement | Rahul Songire, Vice President – Central Quality Zydus Lifesciences Limited | |
| 9:10 – 9:50 AM | GMP-Related QMS Requirements for Medical Device | Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine | |
| 9:10 – 9:50 AM | Building and Managing Your Audit Team | Andrea Roether, Senior Director of Global Quality Creation Technologies | |
| 10:00 – 10:40 AM | Select Between Knowledge Exchange Sessions | ||
| 10:00 – 10:40 AM | Navigating Regulatory Changes: Ensuring Compliance through Effective Change Control | Mentor Technical Group | |
| 10:00 – 10:40 AM | Developing a Site Preparation Strategy for a Successful FDA Inspection | Russell Wilson, MS, PhD, Senior Compliance Consultant / Client Lead QACV Consulting, LLC | |
| 10:00 – 10:40 AM | Use Statistics as a Risk Management Tool | Raul Soto, Senior Manager MedTech Supply Chain Johnson & Johnson | |
| 10:45 – 11:00 AM | Exhibitor Showroom and Refreshment Break | ||
| 11:10 – 12:00 PM | Select Between Knowledge Exchange Sessions | ||
| 11:10 – 12:00 PM | Identifying KPI’s & Quality Metrics in a GMP Environment | ||
| 11:10 – 12:00 PM | Currents Trends and Case Studies Utilizing Artificial Intelligence and Machine Learning | Gaurav Walia, Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner PQE Group | |
| 11:10 – 12:00 PM | From Concept to Implementation: Steps to Build a Change Control Framework | Mentor Technical Group | |
| 12:00 – 1:00 PM | Lunch and Learn | ||
| 1:10 – 1:50 PM | Select Between Knowledge Exchange Sessions | ||
| 1:10 – 1:50 PM | ICH Q10 & Change Control Strategies | Joscelyn Bowersock, Senior Director Quality Assurance and Regulatory, Precision for Medicine | |
| 1:10 – 1:50 PM | Build Your Custom Audit Checklist – Interactive Master Class | David W. Vincent CSO/ B.Sc., MPH, P.hD., Chief Scientific Officer VTI Life Sciences | |
| 1:10 – 1:50 PM | The Human Factor: Understanding and Addressing Behavioral Risks in GMP Operations | Rahul Songire, Vice President – Central Quality Zydus Lifesciences Limited | |
| 2:00 – 3:00 PM | Speed Networking & Training | ||
| 2:00 – 3:00 PM | Case Study: Quality Oversight | Fred Ohsiek Cleaning Validation Expert | |
| 2:00 – 3:00 PM | Material Qualification Programs & GMP Compliance | Focus Labs | |
| 2:00 – 3:00 PM | Case Study: Risk Management in the GMP Environment | Joe Ault, Senior Product Marketing Manager, Software Thermo Fisher Scientific | |
| 3:10 – 3:20 PM | Exhibitor Showroom and Refreshment Break | ||
| 3:30 – 4:10 PM | Select Between Knowledge Exchange Sessions | ||
| 3:30 – 4:10 PM | Ask the FDA: Bring Your Compliance Questions | Katelyn Staub-Zamperini, Senior Operations Officer ORA, FDA | |
| 3:30 – 4:10 PM | GMP Compliance: Conducting Annual Product Reviews | Speaker, Title, Company | |
| 4:20 – 5:00 PM | Select Between Knowledge Exchange Sessions | ||
| 4:20 – 5:00 PM | Developing, Implementing and Mantaining GMP Data Integrity | CAI | |
| 4:20 – 5:00 PM | Annex 1 Contamination Control – What the Recent Revision Means for Your Organization | Cindy Duhigg, Global Process Validation Steward Alcon | |
| 4:20 – 5:00 PM | Close of Conference |
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