PDA Metro Chapter: 17th Annual Chapter Day
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.
Event Location
225 Route 202, Basking Ridge, NJ 07920 Get DirectionsContact
Chapter Inquiries
Membership Services
Late Registration after May 3rd
Member Price
$300.00Non-Member
$400.00
Day 1
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
Featured Presenters
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James P. Agalloco, BEChE, MSChE, MBA
Agalloco & Associates Inc.
Read BioJames P. Agalloco, BEChE, MSChE, MBA
Agalloco & Associates Inc.
James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 200 health care firms in a wide range of validation, automation and compliance areas. Jim has over 45 years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP’s Microbiology Expert Committee for 2005-2020. He serves on the Editorial Advisory Boards of Pharmaceutical Technology and Pharmaceutical Manufacturing. Jim serves on the scientific advisory boards of MEDInstill and Eniware. He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation.
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Thomas Corizzi
Manager, Digital Capability Managment, Quality Systems, Bristol Myers Squibb
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Glenn Corrington
Director, Quality Assurance and Quality Systems, Nevakar LLC
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Arti Jinsi-Parimoo, Dr.
Director, CMC Regulatory Affairs, Regeneron
Read BioArti Jinsi-Parimoo, Dr.
Regeneron
Dr. Arti Jinsi-Parimoo has expertise in manufacturing and regulatory development of pharmaceuticals and medical devices through various stages of clinical development to global commercial path. Led and managed projects to meet time-cost objective with high quality results. Performance-driven scientist adept in innovative management practices that drive business growth via collaborations. Expanded skill expertise in clinical and regulatory drug/device development through certification and hands-on practice. She is also a NJ Registered and Authorized Nuclear Pharmacist with RAC certification.
Dr. Arti Jinsi-Parimoo specializes in regulatory strategic support for development of small molecules, biologics and medical devices, clinical supply and trials and post-marketing support, Project management, QA and Compliance, technical expertise in development of analytical and bioassays for RNA, DNA and protein analysis, protein purification, cellular analysis, assay design, cell culture & animal models, chromatographic & fluorescent methods, GPCRs, signal transduction, receptor pharmacology, oncology, inflammation, cardio-vascular markers, diagnostic imaging modalities, six sigma quality.
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Rebecca D. Jordan
Associate Director, GMSAT, Bristol Myers Squibb
Read BioRebecca D. Jordan
Bristol Myers Squibb
Rebecca Jordan is Associate Director, GMSAT at Bristol Myers Squibb. She has over 10 years’ experience in industry as a QC Microbiologist, where she has supported both large and small manufacturing firms, commercial facility start-up, development through licensure of parenteral drugs, facility and utilities monitoring, APS, CAPA, and quality risk management to name a few. She has also successfully navigated global regulatory audits, developed and implemented aseptic training programs, established EM trend and disinfectant efficacy programs, and consulted on new facility design projects for CAR-T therapy manufacturing. She is a keen investigator whose curiosity and dedication has led to a diverse and rewarding career. She holds a B.S. in Biology from Fitchburg State University.
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Devon Kleinsienst
Bristol-Myers Squibb Company
Read BioDevon Kleinsienst
Bristol-Myers Squibb Company
Devon Kleindienst is a Research Scientist II at Bristol-Myers Squibb Company. Currently part of the Analytical Strategy and Operations team, she is a microbiologist specializing in endotoxin and pyrogen detection. She holds a B.S. degree from the University of Pittsburgh and a M.S. in Microbiology from Seton Hall University.
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Carly Krystopik
Principal Scientist, Bristol Myers Squibb
Read BioCarly Krystopik
Bristol Myers Squibb
Carly is a microbiologist with over ten years of experience, specializing in review of GMP testing and documentation. Ensures current practices are in compliance with industry guidelines and regulatory expectations. Experienced in review of Bacterial Endotoxin (Gel Clot and Kinetic) Routine and Validation, TOC, Conductivity, HPC, Microbial Identification, Bioburden, MLT, Growth Promotion, Antibiotic testing, and AET. Also, skilled in review of autoclave qualifications, Biological Indicator verification and release, and numerous equipment calibrations. Proficient in creation, review and revision of procedures, protocols, reports and forms.
She performs in-process bioburden testing of parenteral products and in-use hold time studies of final products to define commercial labelling requirements. -
Jennifer Metch
Plant Microbiologist, Janssen CAR-T
Read BioJennifer Metch
Plant Microbiologist, Janssen CAR-T
Jennifer is the Plant Microbiologist within the Janssen CAR-T Advanced Therapies Supply Chain and has been with Johnson & Johnson for 26 years. Her areas of focus include collaboration with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products, define specific aseptic techniques to be performed for crucial process steps and provide input to processing operations, ensure microbiological control strategy is consistent with cGMP and Janssen requirements , design, maintain and deliver aseptic technique and microbiology awareness training program, maintain, re-evaluate and communicate KPIs to site environmental monitoring program, support process microbiological investigations, identify risks and opportunities in relation to contamination control on the manufacturing floor and drive follow-up initiatives for improvement in cooperation with operators, QC and operations management. Jennifer has a B.S in Biology from Stockton University. -
Ryan Pachuchki
Principal Scientist, Bristol Myers Squibb
Read BioRyan Pachuchki
Bristol Myers Squibb
I use my passion and skills at BMS in the Microbiology Center of Excellence. I help support the network with my expertise in validating novel technology and molecular biology. I lead validation and qualification of new technology. My main goal is to help get life saving medicine to patients faster with the highest level of excellence by using my scientific expertise and the validation of novel assays.
I have worked at the New Jersey Department of Health in molecular virology section. My main task was to sequence SARs-CoV2. We sequenced about 200 samples a week and publish those results to GISAID. We were able to detect the first omicron variant in NJ. I have helped validate new assays and I was the main sequencer at the laboratory bench. I am skilled in validating new assays.
My dissertation work was focused on how bacterial infections can increase the severity of the Lupus. I developed a novel ELISA to detect antibodies against bacterial biofilms. I demonstrated these antibodies correlate with disease flares. My passion for science comes from my mother Eileen and Aunt Kas passing away from Lupus and other autoimmune complications. I made a promise to never forget them. May my work be proof of my dedication to that promise and determination to continue to fight against diseases that can cut short the most cherished things in life.
As a result, I am willing to use my talents to serve the community for a larger accomplishment than my own endeavors to increase human health quality. -
Alicia Riesgo
Compliance, Sr. Regional Director, IPS
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Robert D. Seltzer
Principal Consultant, Worldwide GMP Compliance Professional
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Sandra Toledo
Senior Manager, CAR-T, Bristol Myers Squibb
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Aaron Zajicek
Associate Director, Global Regulatory Sciences, Bristol Myers Squibb
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