Sheraton Chapel Hill Hotel
One Europa Drive Chapel Hill, North Carolina 27517
Early Bird Pricing Ends
Friday, September 13th, 2024
AGENDA
Day 1
| Time | Session Title | Speaker | Session Description |
|---|---|---|---|
| 12:00 – 1:00 PM | Registration – Coffee & Tea | ||
| 1:00 – 1:15 PM | Chairperson’s Opening Remarks | ||
| 1:15 – 2:15 PM | Panel Discussion: Aligning to GMP Regulatory Developments & Updates – EU vs. FDA vs. WHO | Moderator: Saurabh Joshi, Director-Solution Engineering Valgenesis Panelists: 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 | Parsa Famili, President & CEO 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 |
GMP University
Join us at GMP University, where excellence in Good Manufacturing Practices awaits! Join us for an enriching 3-day conference and training program crafted to deliver the latest insights and best practices in change control, risk management, audits/inspections, quality metrics, and quality management systems.
Explore a diverse range of topics, including Inspection Readiness, Quality Risk Management, Data Integrity, Change Control, Quality Systems Management, Quality Metrics, and don’t miss our special focus on the transformative Impact of AI on GMP practices. Led by seasoned industry professionals, our expert speakers will share invaluable insights, real-world experiences, and compelling case studies to empower/educate your GMP journey.
Network with industry peers, engage in hands-on training sessions, and gain practical insights to enhance your professional expertise. Don’t miss this opportunity to elevate your skills and stay ahead of the curve.
Join us at RTP, North Carolina, from October 22-24, 2024, for an unforgettable experience featuring over 35+ sessions. Reserve your spot today and take your GMP knowledge to new heights! Agenda to come soon!
