# Event Details - **Event Name**: Applied Quality Risk Management: Practical Skills Workshop - **Event Start and End Date**: Thu, 11 Jun, 2026 at 08:30 am – Thu, 11 Jun, 2026 at 04:30 pm (-04:00) - **Event Description**: Hosted by the Parenteral Drug Association (PDA) Southeast Chapter:About this EventFirst 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.πŸ“… Date: Thursday, June 11⏰ Time: 8:30 AM – 4:30 PMπŸ“ Location:Apella by Alexandria12 Davis Dr, Durham, NC 27713https://www.apella.com/apella-rt/Detailed Agenda:8:30 – 9:30 AM | Keynote Speaker: Dan Heath, #1 New York Times bestselling author9:30 - 9:35 AM How the Day Works9:35-10:00 AM | Session 1 β€” FDA Compliance Trends in Quality Risk ManagementPresenter: Nathan Blazei, Kymanox10:00 – 10:15 AM | Break10:15 – 12:00 PM | Session 2 β€” QRM Tools + Formality: Right-Sizing the Approach and Application10:15-10:35 AM | QRM Tools + Formality: Right-Sizing the ApproachPresenter: Amanda McFarland, ValSource, Inc. 10:35-11:05 AM | QRM for Container Closure Integrity: An Application Case StudyPresenter: Oliver Stauffer, PTI - Packaging Technologies & Inspection 11:05-12:00 PM | Workshop Activity & Discussion12:00 – 1:00 PM | Lunch1:00 – 2:00 PM | Session 3 β€” Risk Profiling, Risk Registers, and Risk Reporting1:00-1:25 PM | Getting QRM in the Door - Risk Registers to drive decisionsPresenter: Malav Parikh, Takeda1:25 - 2:00 PM | Risk Profiles: Impact over ActivityPresenter: Jon Williams, ValSource, Inc. 2:00 – 2:15 PM | Break2:15 – 2:40 PM | Session 4 β€” Master Planning - How to Ensure QRM Adds ValuePresenter: Kelly Waldron, ValSource, Inc. 2:40 – 3:15 PM | Session 5 β€” Applying QRM Principles to Improve Clinical OutcomesPresenter: Lori Richter, Enterey Life Sciences Consulting3:15 – 4:00 PM | Session 6 β€” Case-Based Learning: Inspection Findings β†’ β€œWhat Would Have Prevented This?”3:15 – 4:00 PM Case Study Workshop Activity & Discussion4:00 – 4:20 PM | Wrap-Up: Pulling It Together + Next Steps - **Event URL**: https://allevents.in/durham/applied-quality-risk-management-practical-skills-workshop/100001987016805755 - **Event Categories**: workshops, art, literary-art - **Interested Audience**: - total_interested_count: 0 ## Ticket Details - **Ticket Price Range**: min: 150, max: 275, currency: USD ## Event venue details - **city**: Durham - **state**: NC - **country**: United States - **location**: Apella by Alexandria - **lat**: 35.8972393 - **long**: -78.8604862 - **full address**: Apella by Alexandria, 12 Davis Drive, Durham, United States ## Event gallery - **Alt text**: Applied Quality Risk Management: Practical Skills Workshop - **Image URL**: https://cdn-az.allevents.in/events3/banners/9442f1aa243b7c19cd9222b565bcace629c076769ed2b5b1acd9125bebdaa49f-rimg-w1200-h600-dcffffff-gmir.jpg?v=1775907311 ## FAQs - **Q**: When and where is Applied Quality Risk Management: Practical Skills Workshop being held? - **A:** Applied Quality Risk Management: Practical Skills Workshop takes place on Thu, 11 Jun, 2026 at 08:30 am to Thu, 11 Jun, 2026 at 04:30 pm at Apella by Alexandria, 12 Davis Drive, Durham, United States. - **Q**: How much do tickets cost for Applied Quality Risk Management: Practical Skills Workshop? - **A:** Ticket prices for Applied Quality Risk Management: Practical Skills Workshop range from USD 150 to USD 275 depending on the ticket type. Here's a full breakdown of available ticket types:Ticket TypePriceAvailabilityEARLY BIRD - PDA Member RegistrationUSD 225AvailableEARLY BIRD - PDA Non-Member RegistrationUSD 250AvailablePDA Member RegistrationUSD 250AvailablePDA Non-Member RegistrationUSD 275AvailableRegulatory RegistrationUSD 200AvailableStudent RegistrationUSD 150Available - **Q**: Who is organizing Applied Quality Risk Management: Practical Skills Workshop? - **A:** Applied Quality Risk Management: Practical Skills Workshop is organized by PDA Southeast Chapter. - **Q**: Who is this event for? Is it right for me? - **A:** Applied Quality Risk Management: Practical Skills Workshop is ideal for curious learners, students, and skill-builders looking to gain hands-on knowledge and practical expertise in a focused, interactive setting. Whether you're a first-time attendee or a longtime enthusiast in Durham, this event is thoughtfully curated to deliver a standout experience worth every moment. 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PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation, so members can better serve patients.The PDA Southeast (PDA SE) Chapter encompasses eleven states, including NC, SC, VA, TN, GA, FL, KY, AL, and MS, and the Executive Board and Committee Chairs consist of professionals from the biotech, pharmaceutical, medical device, and clinical sectors. They collaborate to coordinate events and foster industry partnerships. 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