A Full Plate and Then Some: The Real Work of QC Micro

Schedule

Thu Jul 16 2026 at 08:00 am to 04:30 pm

UTC-04:00
Location

The McKimmon Conference and Training Center at NC State | Raleigh, NC

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A Symposium on QC Micro’s Expanding Responsibilities
About this Event

This QC Microbiology-focused symposium highlights the full scope of QC Microbiology's work - not just the routine testing that everyone sees, but the expanding responsibilities that shape sterile manufacturing everyday.


This one‑day program brings together industry experts, pharmaceutical manufacturing leaders, and QC Microbiology professionals for an honest, in-depth look at the expanding scope of the role and the expectations that keep growing.


🗓️ Date: Thursday, July 16, 2026

⏰ Time:

7:00 AM - 8:00 AM - Registration & Breakfast

8:00 AM - 4:30 PM - Symposium

📍 Location: The McKimmon Conference and Training Center at NC State

1101 Gorman St, Raleigh, NC 27606


Topics include:

- Aseptic Process Simulation/Media Fills

- Isolators & Barrier Systems

- Water System and Bioburden Analysis

- Decontamination Controls & Assurance

- Particulate & Non-Viable Monitoring

- Data Integrity & Digitalization

- Mold Remediation


AGENDA OVERVIEW:

Session 1: Media Fills That Matter – Designing Simulations Around Real Risk

• Designing Media Fills That Reflect Real Manufacturing Risk – Vanessa Figueroa, VVF Science

• Technical Decisions That Shape APS Outcomes – Melissa Reuck, MilliporeSigma

• Enhancing Airflow Visualization Studies to Strengthen Contamination Control – James Wamsley, ValSource


Session 2: Inside the Isolator – Science, Regulation, Behavior, and Barrier System Dynamics

• A Practical Comparison of AHP, IHP, and VHP – Tiffany Alponat, STERIS

• Isolators Under Scrutiny: What Regulators Are Really Looking For – Marsha Steed, Steed MicroBio

• Particle & Microbial Transport in Isolators – Noel Long, Cytiva


Session 3: From Spores to Sensors – Advancing Decontamination Assurance

• Enzyme Indicators & Alternative Monitoring Approaches – Terrance Hollis, Pfizer

• Biofluorescent Particle Counting – Dr. James Hathcock, Cytiva


Session 4: Signals and Safeguards – Managing Risk in Utilities, Data, and the Facility Environment

• Online Water Bioburden Analyzer Technologies – Allison Scott, BWT Pharma & Biotech

• Mastering Data in the Digital Age – Peniel Ortega, PharmAllies

• Battle Against Mold: Strategies for Environmental Control – Crystal Booth, ThermoFisher Scientific



Who Should Attend:
  • QC Microbiology
  • Aseptic Operations
  • Sterile & Non-Sterile Manufacturing
  • QA & Regulatory Compliance
  • Contamination Control & EM Teams
  • Facility & Utility Owners
  • Anyone who wants to expand their knowledge on sterility assurance


Limited Vendor/Exhibitor tables are available!


Hosted by the Parenteral Drug Association (PDA) Southeast Chapter

For more info and details, please email [email protected]


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Where is it happening?

The McKimmon Conference and Training Center at NC State, 1101 Gorman Street, Raleigh, United States

Event Location & Nearby Stays:

Tickets

USD 15.00 to USD 1000.00

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PDA Southeast Chapter
Host or PublisherPDA Southeast Chapter

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