PBOA
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INTERPHEX Panel: Quality Agreements
April 22, 2015 @ 2:15 pm - 3:00 pm
Location: INTERPHEX Innovation Stage 2, Exhibit Hall
The FDA is working on a Guidance detailing its suggested uses for Quality Agreements, the written agreements that define responsibilities for CMOs and their clients. This panel, moderated by Alan Minsk (Partner, Arnall Golden Gregory) will discuss approaches and best practices regarding Quality Agreements. What are they for? What goes into a good one? How do clients and CMOs find common ground to codify quality expectations and responsibilities? What do regulators expect Quality Agreements to cover?
Participants:
- Scott Gunther • Vice President, Advanced Delivery Systems, Catalent Pharma Solutions
- Andrew McNicoll • VP Quality Systems and Compliance, Patheon
- Lisa Thimmesch • Customer Quality Manager, Hospira One 2 One™
- Jessica Walker • Director of Quality Assurance, Afton Scientific/AnovaFill
For more information, visit the INTERPHEX page for this session.