Agenda | Event Presentations | USP Education Videos
Alcohol-based hand sanitizer is an important element in infection prevention, especially during the COVID-19 pandemic. However, when quality is compromised, it can be less effective against infection transmission and can also lead to user harm.
COVID-19-related supply chain pressures have created global shortages that led to new vendors, materials, and production pathways to meet demand. These fast-paced changes have caused an emergence of quality incidents both regionally and globally. Globally, over 200 alcohol-based hand sanitizer quality incidents have been reported in 2020. Specifically, in the United States, approximately 80 alcohol-based hand sanitizer quality incidents were reported in 2020.
On February 23, 2021, USP hosted a Global Seminar, Ensuring Quality Hand Sanitizer Production During COVID-19, to help ensure quality alcohol-based hand sanitizer production and support the safe use of alcohol-based hand sanitizer.
Seminar Topics
Presenters and panelists from USP, U.S. FDA, industry, and public health institutions will discuss the global and regional quality risks and solutions when producing alcohol-based hand sanitizer (including its ingredients such as alcohol), including:
- Global quality challenges and public health impact of alcohol-based hand sanitizers from import/export regulations to clinical perspectives on the frontline treating consequences from subquality products
- Regional regulatory and public health strategies to increase trust in alcohol-based hand sanitizers
- Standards, current Good Manufacturing Practices (cGMPs), and mitigation strategies for the production (including ingredients such as alcohol), labeling, packaging, storage, transportation, and distribution of alcohol-based hand sanitizer
- Ingredient verification services to help ensure the quality of the ingredients used in alcohol-based hand sanitizer as well as assist with the qualification of ingredient suppliers
- Manufacturing perspectives and best practices from industry peers’ sharing insights on quality in action
Presenters and Panelists
U.S. FDA
- Francis Godwin, M.B.A., Director, Office of Manufacturing Quality
- Theresa Michele, M.D., Director, Division of Nonprescription Drug Products
Industry & Public Health Institutions
- Christopher Penzien, Associate Director – Quality Assurance, Perrigo
- Michael Wisser, Director – CSCA Analytical R&D, Perrigo
- Daniel E. Brooks, M.D., Medical Director, Banner Poison & Drug Information Center
USP
- Ronald T. Piervincenzi, Ph.D., Chief Executive Officer
- Danita Broyles, M.S., Senior Market Development Manager
- Desmond G. Hunt, Ph.D., Principal Scientific Liaison, Science-General Chapters
- Catherine Sheehan, DRSc, M.S., M.S., Senior Director, Science-Excipients
- Misti Spann, Pharm.D., Scientific Liaison, Science, Healthcare Quality & Safety
- Nurisha Wade, Vice President, Healthcare Quality & Safety
Who should attend?
- Manufacturers with alcohol-based hand sanitizers as part of their production portfolio
- Regulatory agencies who support alcohol-based hand sanitizer manufacturers
- Other interested industry groups
Executive Summary
Event Presentations
The approved presentations will be posted upon approval by the presenters.
- Why Quality Alcohol-based Hand Sanitizer Matters, Nurisha Wade
- Current State of Alcohol-based Hand Sanitizer: A Regional Perspective, Theresa M. Michele
- Ensuring the Public's Trust in Using Alcohol-based Hand Sanitizer: Regulatory Overview, Francis Godwin
- Formulating Quality Alcohol-based Hand Sanitizers: The Value of USP-NF Standards, Catherine Sheehan
- USP Ingredients Verification Program (IVP), Danita Broyles
- Labeling, Packaging, Storage, & Distribution: Ensuring Quality During Hand Sanitizer's Journey, Misti Spann
- Labeling, Packaging, Storage, & Distribution: Ensuring Quality During Hand Sanitizer's Journey, Desmond Hunt
- Delivering on Quality-A Manufacturers Perspective, Chris Penzien and Mike Wisser
- Why It Matters: An Impact Perspective, Daniel Brooks
For further information, please contact Jacqueline D. Starkes.