9-10:30 AM EST
Join Association for Accessible Medicines, U.S. FDA, and USP to learn how participating in USP standards development can enhance product quality and regulatory predictability across a drug product’s lifecycle – from discovery to delivery.
Public quality standards are universally recognized as essential tools that support the design, manufacture, testing, and regulation of drug substances and products. USP standards play a critical role in helping ensure the quality and safety of medicines marketed in the United States and worldwide. Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate via public comment in the development of future standards.
Topics covered
- FDA’s responsibility in USP standards development
- Value/role of USP monographs for FDA
- How the use of standards - and demonstrated compliance - factor into FDA’s regulatory activities
- Industry’s position in USP standards development
- Manufacturers’ part in the establishment of USP standards
- Overview of USP standards in regulatory framework
- Discussion of the USP revision process
- How to get involved in monograph development
Intended audience
This webinar is designed for regulatory and quality professionals in regulatory affairs, quality assurance, and product development who support drug applications across brand-name and generic industries; FDA reviewers and policymakers interested in how USP standards support regulatory decision-making and public health protection; industry compliance officers and quality managers ensuring products meet federal requirements including GMPs and compendial standards; and pharmaceutical consultants who guide clients through USP standards for market authorization and post-market compliance.
Speakers
Industry Role in USP Standards Development
Scott Kuzner, Senior Director | Science and Regulatory Affairs
Association for Accessible Medicines
FDA’s Participation in USP-NF Revision Process- Challenges and Solutions
Pallavi Nithyanandan, Director | Compendial Operations and Standards Staff
Office of Pharmaceutical Quality
Center for Drug Evaluation and Research | FDA
USP Standards: Value to Industry and Regulators
Matthew Vankoski Director | Donations
USP
Panelist
Kristie Laurvick, Senior Regulatory Engagement Manager
U.S. Government and Regulatory Affairs
USP