PDA Metro Chapter
Chapter's Region:
New Jersey (Northern) / New York
The PDA Metro Chapter serves the New Jersey, New York and Pennsylvania Tri-State area as an extension of PDA International. The local chapter focuses its efforts towards organizing and providing local events targeted at scientists involved in the development, manufacture, quality control and regulatory affairs for pharmaceuticals and related products.
The PDA Metro Chapter is comprised of PDA members from the NJ and metropolitan NY area and is managed by the operating team comprised of volunteers.
The PDA Metro Chapter organizes dinner meetings throughout the year. The focus of the meetings is to provide industry professionals involved in the development, manufacture, quality control and regulation of pharmaceuticals/ biopharmaceuticals and related products the ability to converse in an educational environment while enjoying presentations from the top industry professionals.
It offers an opportunity to network within the industry in an enjoyable and informative setting. The dinner meetings are usually held at various hotels in NJ and include a networking hour, dinner and a featured presentation from a time period between 5:00 p.m. until 8:30 p.m. The PDA Metro Chapter aspires to be an integral link in education and is always looking for new volunteers whom may assist us in our efforts. Your support, comments and suggestions are the mechanism to our improved success.
Sponsors
The PDA Metro Chapter is grateful to our dedicated members and sponsors for their continued interest, participation and support. We truly appreciate the generosity of our sponsors, for without you, we could not provide these valuable educational and social networking to our members.
Interested in our Discounted Packages?
Please send the name(s) of the attendee(s) five (5) days prior to the event date. You can send the names of attendees and or address any registration questions to: pdametro@yahoo.com.
Please contact Betsy Anda-Harris for additional information.
2023 Platinum Sponsors
2023 Gold Sponsors
2023 Silver Sponsors
Member At Large
- James Agalloco, Agalloco & Associates
- Nate Manco, ECO Animal Health
- Leticia Quinones, Bristol Myers Squibb
- Mary Ly Huynh, Bracco Diagnostics Inc.
Immediate Past President
- Tony Grilli, Focus Laboratories
Chapter Officers
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Rekha Nayak
Secretary
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Nrupa Patel
Treasurer
Teligent, Inc.
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Sandip Patel
Social Media Chair
Navinta, LLC.
Presentations & Resources
- Risk-Based Validation and Requalification of Processes & Equipment, Nancy Tomoney
- In-Process Changes to USP 1211 Sterilization & Sterility Assurance of Compendial Articles
- Preliminary Audit to a Pre-Approval Inspection
- Risk Based Environmental Monitoring (EM) and EM Data Management and Trending
- Mitigating Raw Materials Risk for Supply Chain Continuity Tom Dinka
- EMA’s Annex 1 - 2022 Preparation & Perils
- GMPs for the 21st Century A Risk-Based Approach, Steven Ostrove
- Microbiology Best Laboratory Practices
- FDAs Guidance for Industry Process Validation
- Changing Pradigms in Aseptic Processing
- Pharmaceutical Ultrapure Water Systems - What Pharma Can Learn
- FDA Inspectional Approach Paul Bellamy
- FDA Quality Metrics
- Template Aseptic Mdeida Fill Investigation
- Disinfection Processes
- Sterilization A to Z
- Disaster Recovery & Business Continuity - related but NOT the Same Teri Stokes PhD
- Defining a strategy for the Validation and Qualification of Sterile Filtration Processes of Investigational Medicinal Compounds
- Preservative Formulation and Effectiveness in Oral Solutions and Suspensions
- Risk Based Environmental Monitoring (EM) and EM Data Management and Trending
- 483s-Not Here
- State of the Pharmaceutical Industry
- FDA API Inspections Robert Horan PhD
- Thinking About Risk and Endotoxin Control
- ICH Q11 - Development and Manufacture of Drug Substances
- Team Biologics Inspection Approach
- Outsourcing R&D Stability Studies - Successes and Lessons Learned
- Using Risk Management To Put the Design in QbD William Bennett
- Cleaning Processes and Microbial Controls
- Regulatory Perspective on Key USP General Chapters in aMicrobiology
- Glass Delamination Risks Reality and Regulatories
- FDA Perspective Risk Based Cleaning Sanitization and Sterilization
- FDA Enforcement Update
- Implementation of Single-Use Systems Benefits and Challenges
- Template Investigation of Sterility Test Failure
- Cold Chain Shipping - Protecting Temperature Sensitive Products Diane McLean
- Highlights USP Expert Microbiology Committees Activities Related to Endotoxin
- Recent USP Updates
- Data Integrity for the Microbiology Laboratory
- Success with Manual Aseptic Processing
- Template Environmental and Personnel Monitoring Investigation for OOS Result
- Strategies for Developing Biosimilars and Biobetters
- USP Activities Impacting Sterilization & Sterility Assurance
- Sterile Product Package Integrity Testing
- Current Trends in Process Validation- The New Paradigm
- End User Testing for Performance Qualification of GXP Part 11 Systems - Off the Shelf - OTS - Teri Stokes PhD
- Canadian Pharmaceutical GMP Richard Pike
- Overview of Pre-Approval Inspections
- Microbiological Considerations for Non-Sterile Pharmaceutical Products
- COVID19 Pandemic & Supply Chain Disruption Risks Associated with Reusables in the Aseptic Processing Area
- A Risk-Based Model for Choosing in Process Testing Sites Karen McCullough
Chapter Resources
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