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 24, 2021, U.S.P. 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 U.S.P., U.S. F.D.A., healthcare provider groups, and public health institutions will discuss the global and regional quality risks and solutions when compounding alcohol-based hand sanitizer, including:
- Global quality challenges and public health impact of alcohol-based hand sanitizers from compounding 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 and mitigation strategies for the compounding, labeling, packaging, storage, transportation, and distribution of alcohol-based hand sanitizer
- Compounding professionals’ perspectives and best practices from clinical peers’ sharing insights on quality in action
Presenters and Panelists
U.S. F.D.A.
- Frances Gail Bormel, R.PH., J.D., Acting Director for the Office of Compounding Quality and Compliance in (CDER) Office of Compliance | U.S. F.D.A.
- Francis Godwin, M.B.A., Office Director, Office of Manufacturing Quality
- Theresa M. Michele, M.D., Director, Center for Drug Evaluation and Research's Division of Nonprescription Drug Products
Industry & Public Health Institutions
- Tracy Acosta, Compounding Pharmacist, Preston Road Pharmacy
- Daniel E. Brooks, M.D., Medical Director, Banner Poison & Drug Information Center; Banner University Medical Center-Phoenix Department of Medical Toxicology
U.S.P.
- Ronald T. Piervincenzi, Ph.D., Chief Executive Officer
- Desmond G. Hunt, Ph.D., Principal Scientific Liaison, Science-General Chapters
- Brenda Jensen, Chair, Compounding Expert Committee
- Brian Serumaga, Senior Manager-Personalized Medicines/Scientific Liaison
- Misti Spann, Pharm.D., Scientific Liaison, Science, Healthcare Quality & Safety
- Jacqueline D. Starkes, Senior Stakeholder Affairs Coordinator
- Nurisha Wade, M.B.A., Vice President, Healthcare Quality & Safety
Who should attend?
- Compounders who are making alcohol-based hand sanitizers
- Regulatory agencies who support compounders
- Other interested healthcare provider groups or public health institutions
Executive Summary
Event Presentations
- 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 Sanitizer, Brian Serumaga
- Formulating Quality Alcohol-based Hand Sanitizer, Brenda Jensen
- Ensuring Quality Hand Sanitizer Production - Labeling Compounding, Misti Spann
- Labeling, Packaging, Storage, & Distribution: Ensuring Quality During Hand Sanitizer's Journey, Desmond Hunt
- The Dos and Don'ts for Compounding_Alcohol-based Hand Sanitizer, Tracy Acosta
- Why It Matters: An Impact Perspective, Daniel Brooks
For further information, please contact Jacqueline D. Starkes.