Overview
The third annual CPhI North America conference will bring together 6,500+ pharma and chemical professionals representing the pharmaceutical supply chain from manufacturing to distribution. USP is proud to partner once again with CPhI to support an informative program that will help all of us meet our shared goals.
USP leaders will deliver presentations on the role of our standards throughout the entire drug supply chain ranging from drug formulation to patient delivery; new USP efforts related to supplier qualification and selection; and compendial and regulatory approaches to impurities and USP’s new service on impurities for drug development.
Visit us at Booth #2330 where we’ll be on hand to answer your questions about:
- USP Reference Standards
- Verification programs from USP
- Impurities for Development service
- Partnering with USP to help drive the science that shapes our public standards
- Exciting opportunities to join our independent network of USP experts
Email us to schedule meetings during CPhI. We look forward to seeing you at Booth #2230.
Meeting Registration Exhibitor Showcase Presentations
Register for CPhI North America, and receive 20% off CPhI North America Registration when you use promo code 10USP19.
For questions completing your registration, contact CPhI North America at (415) 947-6940 or (866) 217-1926, Monday - Friday, 8:00 am - 6:00 pm CST.
Exhibitor Showcase Presentations
Join us at the Exhibitor Showcase Theater for presentations from USP and interact face-to-face with our leaders on the topics below. Attendance open to all attendees.
Wednesday, May 1 | 1:30 pm – 2:00 pm
USP in the Supply Chain: More than Monographs (Part 1)
Speaker: John Giannone
Presentation description:
A presentation showing the impact of USP activities on every step of the drug supply chain from drug formulation through patient delivery.
You will learn:
- How USP General Chapters provide information beyond compendial compliance for monographs
- How USP is working around the world to impact patient health on a local basis
- How USP works closely with manufacturers, regulators and other pharmacopeias to help ensure the quality of medicines and their delivery to patients.
John Giannone, M.B.A., is Senior Director of Strategic Marketing and Program Operations for Excipients at US Pharmacopeia (USP). John joined USP in June of 2016 with over 15 years of experience in the Pharmaceutical Excipients business, including serving as Chairman of IPEC – Americas, and is responsible for commercial activities at USP related to Excipients. John has more than 35 years of chemical industry experience including Research and Development, Supply Chain, Marketing, Sales/Sales Management and Business Management.
Wednesday, May 1 | 2:00 pm – 2:30 pm
USP in the Supply Chain: More than Monographs (Part 2)
Speaker: John Giannone
Presentation description:
A presentation about the exciting new work by USP in Supplier Qualification.
You will learn:
- The background of why USP has chosen to move forward with a General Chapter approach to Supplier Qualification
- The basis and evolution to the current approach of a Joint Expert Panel, and how that will help produce a new standard in Supplier Qualification
- How individuals can help in the process
About other tools that USP has to help companies evaluate and select supplier partners that help ensure the quality of medicines.
Wednesday, May 1 | 2:30 pm – 3:00 pm
Impurities for Development
Speaker: Ashok Dang
Presentation description:
Impurities can occur naturally within source materials or as part of a product’s synthesis, be introduced inadvertently during processing and manufacturing, or form during the shelf life of the product. Manufacturers have to ensure the quality and consistency of ingredients that go into a final pharmaceutical product. As a result, manufacturers have to deal with many impurities-related demands during the development cycle, including:
- Prediction of likely impurities
- Detection, identification, quantitation and characterization of impurities
- Control of impurities levels or degradation products
- Compliance with regulatory expectations
You will learn about:
- Impurities (an overview)
- USP approaches for impurities
- FDA approaches for impurities
- The USP Impurities for Development program
Ashok Dang, Ph.D., joined USP in 2006. As Senior Director of Strategic Marketing and Program Operations for Chemical Medicines at USP, he leads efforts to visualize USP products and services that address the needs of the pharmaceutical industry. He is a key USP contact for industry stakeholders in the chemical medicines arena, with specific emphasis on pharmaceutical impurities. Ashok has more than 20 years of experience in the pharmaceutical industry and the analytical instrumentation field including stakeholder relations with industry, government and academia in the South Asia region. Ashok’s focus also includes regulations and strategy.