About this Event
First introduced in 2005, ICH Q9 Quality Risk Management has influenced how teams approach risk across the pharmaceutical and biopharmaceutical sectors.
Through hands-on activities, case examples, and group discussions, attendees will build deeper insight into what works now, what still needs attention, and how risk management continues to evolve.
📅 Date: Thursday, June 11
⏰ Time: 8:30 AM – 4:30 PM
📍 Location:
Apella by Alexandria
12 Davis Dr, Durham, NC 27713
https://www.apella.com/apella-rt/
Detailed Agenda:
8:30 – 9:30 AM | Keynote Speaker: Dan Heath, #1 New York Times bestselling author
9:30 - 9:35 AM How the Day Works
9:35-10:00 AM | Session 1 — FDA Compliance Trends in Quality Risk Management
Presenter: Nathan Blazei, Kymanox
10:00 – 10:15 AM | Break
10:15 – 12:00 PM | Session 2 — QRM Tools + Formality: Right-Sizing the Approach and Application
10:15-10:35 AM | QRM Tools + Formality: Right-Sizing the Approach
Presenter: Amanda McFarland, ValSource, Inc.
10:35-11:05 AM | QRM for Container Closure Integrity: An Application Case Study
Presenter: Oliver Stauffer, PTI - Packaging Technologies & Inspection
11:05-12:00 PM | Workshop Activity & Discussion
12:00 – 1:00 PM | Lunch
1:00 – 2:00 PM | Session 3 — Risk Profiling, Risk Registers, and Risk Reporting
1:00-1:25 PM | Getting QRM in the Door - Risk Registers to drive decisions
Presenter: Malav Parikh, Takeda
1:25 - 2:00 PM | Risk Profiles: Impact over Activity
Presenter: Jon Williams, ValSource, Inc.
2:00 – 2:15 PM | Break
2:15 – 2:40 PM | Session 4 — Master Planning - How to Ensure QRM Adds Value
Presenter: Kelly Waldron, ValSource, Inc.
2:40 – 3:15 PM | Session 5 — Applying QRM Principles to Improve Clinical Outcomes
Presenter: Lori Richter, Enterey Life Sciences Consulting
3:15 – 4:00 PM | Session 6 — Case-Based Learning: Inspection Findings → “What Would Have Prevented This?”
3:15 – 4:00 PM Case Study Workshop Activity & Discussion
4:00 – 4:20 PM | Wrap-Up: Pulling It Together + Next Steps
Event Venue & Nearby Stays
Apella by Alexandria, 12 Davis Drive, Durham, United States
USD 150.00 to USD 275.00
