
PDA Metro Chapter: 17th Annual Chapter Day
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
Please join us for this upcoming event!
Themes for Chapter Day include:
- Supplier, Process and Quality
- Process, Quality Enablers Manufacturing
- What Does it Take to Make a Product?
- Ignite Your Motivation
The event will take place at The Old Mill Inn, Basking Ridge, NJ.
Highlighted Presenters
Key Presenters
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Thomas Corizzi
Bristol Myers Squibb
Manager, Digital Capability Managment, Quality Systems
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Glenn Corrington
Nevakar LLC
Director, Quality Assurance and Quality Systems
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Alicia Riesgo
IPS
Compliance, Sr. Regional Director
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Robert D. Seltzer
Otsuka Pharmaceutical Development and Commercialization
Supplier Quality Manager
Read Bio -
Sandra Toledo
Bristol Myers Squibb
Senior Manager, CAR-T
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Aaron Zajicek
Bristol Myers Squibb
Associate Director, Global Regulatory Sciences
Agenda
Discover What's Happening Each Day
08:00am - 08:45am | Continental Breakfast, Registration & Vendor Show
08:45am - 09:00am | Welcome & Announcements, PDA Metro Chapter
09:00am - 9:50pm | Manufacturing Sterile Products 2024 - What do we do now? Jim Agalloco, President, Agalloco & Associates
09:55am - 10:30am | Detection of Mycoplasma Using Novel Automated Multiplex PCR, Ryan Pachuchki Principal Scientist, Bristol Myers Squibb
10:30am - 10:45am | Morning Break
10:50am - 11:20am | Sterilization by Bioburden Reduction Approach. Spore formers in non-overkill cycles – final products <1229> Bioindicator Method, Glenn Corrington, Director, Quality Assurance and Quality Systems, Nevakar LLC
11:25am - 12:00pm | Regulatory Challenges and Considerations in Biologics and CGT, Dr.Arti Jinsi-Parimoo, Director, CMC Regulatory Affairs, Regeneron
12:00pm - 12:55pm | Lunch / Group Pictures
1:00pm - 1:40pm | Panel discussion about making a career change into Cell Therapy after working in other applications – parenterals, biologics, etc. What are the challenges, advantages, and skills to have for people interested in breaking into the cell therapy industry, Rebecca Jordan, Interest Group Lead - ATMP Interest Group, PDA Jennifer Metch, Senior Plant Microbiologist, Janssen CAR-T, Aaron Zajicek, Associate Director, Global Regulatory Sciences – Cell Therapy Group, Bristol Myers Squibb, Devon Kleindienst, Senior Principal Scientist, Microbiology Center of Excellence, Bristol Myers Squibb, and Sandra Toledo, Sr. Manager CAR-T Manufacturing, Bristol Myers Squibb
1:40pm - 2:30pm | Implementing MODA at and Data Analytics for Environmental Monitoring, Carly Krystopik, Principal Scientist, Bristol Myers Squibb and Thomas Corizzi, Manager, Digital Capability Management, Quality Systems, Bristol Myers Squibb
2:30pm - 3:00pm | C&Q Risk Based Approach: How to apply the C&Q risk-based approach methodology for your Facility Project, Alicia Riesgo, Compliance, Sr. Regional Director, Integrated Project Services (IPS), LLC
3:00pm - 3:15pm | Afternoon Break
3:15pm - 3:55pm | Obstacles Encountered in Supplier GMP Auditing and How to Overcome Them … Sometimes, Bob Seltzer, Manager, Supplier Quality Management, Otsuka Pharmaceutical Development and Commercialization (OPDC)
3:55pm - 4:15pm | Panel Discussion/Q&A, PDA Metro Chapter
4:15pm - 4:25pm | Prizes, Closing Remarks, PDA Metro Chapter
*Timing may shift accordingly
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Registration
Pricing Options
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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