Applied Quality Risk Management: Practical Skills Workshop

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/

8:30 – 9:30 AM | Keynote Speaker: Dan Heath, #1 New York Times bestselling author

9:30 - 9:35 AM How the Day Works

Presenter: Nathan Blazei, Kymanox

10:00 – 10:15 AM | Break

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

1:00-1:25 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

Presenter: Kelly Waldron, ValSource, Inc.

Presenter: Lori Richter, Enterey Life Sciences Consulting

3:15 – 4:00 PM Case Study Workshop Activity & Discussion

4:00 – 4:20 PM | Wrap-Up: Pulling It Together + Next Steps

Know what’s Happening Next — before everyone else does.

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Host or Publisher PDA Southeast Chapter