PDA Metro Chapter:  17th Annual Chapter Day

09 May 2024
Basking Ridge, NJ

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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.

Agenda

Discover What's Happening Each Day
Thu 09 May
Thursday, 9 May

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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Contact

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Tel: +1 (301) 656-5900

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