Learn about the when, why and how USP works with industry stakeholders and other pharmacopeias to develop the monographs within the USP-NF.

https://www.pharmtech.com/pt_w/build-a-legacy

Leaders in the industry take a very proactive approach in working with USP and other pharmacopeias globally.

This proactive approach provides many benefits not only to the company but to the protection of public health through the standards setting process.

This webinar will provide insights into how to best work with the pharmacopeia in the development of Standards within the USP-NF that will directly impact your product.

This information will inform the development of your compendial strategy to support regulatory lifecycle management

Understand the best time to engage on the standards development process.

Understanding the implications of proactive vs reactive approach to maintaining compliance with a new USP Standards.

Learn about how USP works with other pharmacopeias through prospective harmonization



This webinar is ideal for anyone interested in enhancing their compendial strategy. We believe it will be particularly beneficial for professionals in Regulatory Affairs, Quality Assurance, Quality Control, and Analytical Research and Development.



Director of Donations Program
United States Pharmacopeia

Matt Vankoski leads the Donations Team at USP, which is responsible for engaging FDA-approved drug substance and drug product manufacturers globally to gain support, methods, and materials. Gaining this support provides the fuel to the beginning of the standard-setting process for specific drug products and drug substance monographs. Matt has over 21 years of experience working at USP and holds a BSc in Chemistry, an MBA, and an MS in Regulatory Sciences.




Director, Quality Assurance Compendial, Analytical, Microbiological, Stability & Special Projects
Harmony Biosciences

Danita Broyles is a native of Clarksdale, MS. She received her B.S. in Chemistry from Rust College and a dual degree M.S. in Biomedical Engineering from the University of Memphis, and the University of TN-Memphis Health Science Center. Danita has an extensive career in the pharmaceutical industry where she tested and released raw materials, performed analytical method validations/transfers, and led compendial compliance and advocacy initiatives throughout her career. Danita is currently the Director of Quality Assurance – CAMS at Harmony Biosciences. She leads a group that specialized in all things Compendial, Analytical, Microbiology, Stability, and Special Projects related at Harmony Biosciences. Danita is Co-Chairperson of the Mid-West Compendial Discussion Group, Treasurer of the New Jersey Pharmaceutical Quality Control Association, and she Co-Chairs the USP Stakeholder Engagement Planning Committee. Danita also serves on the USP’s Nominating Committee for the Council of Experts for the 2025-2030 cycle. Danita is a well sought after speaker who has presented a numerous conferences and events throughout her career.




Senior Manager, Donations Operations
United States Pharmacopeia

Katie McGowan serves as the Senior Donations Operations Manager at the United States Pharmacopeia (USP). In this role, she oversees both external operations for donors and internal processes for the Donations team and scientists. Katie holds a Bachelor of Science in Chemistry with a minor in Communications and a Master of Business Administration. She began her career at USP in 2013 as an analytical chemist in the Reference Standard Laboratory and transitioned to the Donations team in late 2016 as a donation review scientist. Katie is dedicated to advancing the mission of USP through her leadership and expertise.




Senior Manager, Small Molecules
United States Pharmacopeia

Ms. Andrea Carney began her career at USP in 2012 as a Reference Standard Scientist, where she supported the Small Molecules 1 Expert Committee, focusing on antibiotic and antiviral reference standards. In 2016, she transitioned to the Documentary Standards department as a Documentary Standards Scientist, supporting the Small Molecules 3 Expert Committees. This committee concentrated on Gastrointestinal, Renal, Endocrine, Ophthalmic, Oncology, Dermatology, and Animal Health during the 2015–2020 cycle. In the 2020–2025 cycle, Ms. Carney advanced to the role of Senior Manager, supporting the Small Molecules 5 Expert Committee, which focuses on Pulmonary and Steroid medicines. She also supports the OTC-Methods and Approaches Expert Committee, which explored solutions to support OTC products specifically suitable compendial Organic Impurities methods. Before joining USP, Ms. Carney accumulated 15 years of experience in the biotech and pharmaceutical industries. At Medimmune, Human Genome Sciences, and Bristol Myers Squibb, she was involved in routine QC testing, formulation development for large and small molecules, managing GMP stability studies, and writing the CMC section for IND and BLA filings. Ms. Carney holds a BS in Biology with a minor in Chemistry from Howard University in Washington, DC, and an MBA from the University of Maryland University College.




Director-Quality, Compendial Affairs, Global Quality Analytical and QC Operations
Eli Lilly and Company

Erin Wang works in Compendial Affairs for Eli Lilly and Company. Erin’s primary focus is internal and external influence involving requests and requirements of the global pharmacopeias and government agencies. She has a well-established network with compendial and regulatory agencies to achieve critically important results. Erin is recognized as an industry expert and is actively engaged in organizing and speaking at numerous compendial conferences around the world.

Webcasts

Webinar Date/Time: Tue, May 13, 2025 11:00 AM EDT

Strengthening Your Compendial Strategy

Safeguarding the quality of medication is fundamental to protecting the public's health, especially as ingredients and products come from all over the world. 

Biologics are growing faster than any other segment of medicine. Just as they do for chemical medicines, manufacturers must ensure the purity and quality of the biologics that make their way to patients. 

USP quality standards serve as the foundation for a robust safety network that assists manufacturers by increasing predictability and reliability, and preserving the integrity of the global supply chain.



Articles

USP offers a growing portfolio of well characterized monoclonal antibody (mAb) reference standards and associated characterization data.