The Association for GXP Excellence (AGXPE) is pleased to hold this live Mid-Atlantic Chapter meeting at the home facility of one of our sponsors, Red Nucleus (19 W College Ave #300, Yardley, PA 19067). We invite you to join us at Red Nucleus as we launch our first in-person activity since early 2020.
The agenda will be as follows (all times are EDT):
- 2:00PM: Check-in open
- 2:15PM-2:30PM: Opening Remarks
- 2:30PM-2:45PM: AGXPE Leadership Update
- 2:45PM-3:30PM: Harmonizing Quality Management Systems and Training Across GxP Functions – Judy Carmody, PhD (Carmody Quality Solutions)
- 3:30PM-4:00PM: Break / Social (Appetizers with open bar)
- 4:00PM-4:45PM: Post-Inspection Management: Best Practices for Success – Jack Garvey, ESQ (Compliance Architects)
- 4:45PM-6:45PM: Food and Networking
Speaker Bios:
Judy Carmody, Ph.D.
Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC. Dr. Carmody has 25+ years of specific expertise driving vision in operations, Quality assurance, control, systems, validation, and analytical development. She has held Quality leadership positions at several pharma/biopharma companies and built Quality management systems for both start-up and Fortune 500 companies. She is the former founder and president of Avatar Pharmaceutical Services, an FDA-registered contract research organization and registered manufacturer which was acquired by Vertex Pharmaceuticals in 2010.
Prior to founding Avatar, Dr. Carmody spent 10 years in the (bio)pharmaceutical industry, developing methods for small molecules and oligonucleotides, managing QC, Analytical, and Validation groups.
Dr. Carmody holds a Bachelor of Science degree in Chemistry from Worcester State University, and a Master of Science degree and a Ph.D. in Analytical Chemistry from Clark University in Worcester, Massachusetts.
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Jack Garvey, Esq.
Jack Garvey is the founder and Managing Partner of Compliance Architects LLC. In this role, Jack advises pharmaceutical, medical device, biopharmaceutical and other life science manufacturers on complex issues found at the intersection of law, regulation, business operations, quality and compliance.
Jack possesses 35 years of hands-on technical, operational, quality, regulatory and legal experience with leading life science companies. Known for creative, outside-the-box thinking and innovative solution development, Jack employs innovative approaches, based on long-established principles of food and drug law and regulation, to resolve the most complicated compliance and enforcement issues facing regulated manufacturers. Jack earned a Bachelor of Science in chemical engineering from Clarkson University, and a Juris Doctor from Pace University School of Law. Jack is admitted to practice law in New York and New Jersey.
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