January 27 & 28, 2021 9:00 am – 1:00 pm (EST) each day
Alcohol manufacturers, distributors, and brokers—regardless of being new to the market—can take steps to ensure quality and help combat the COVID-19 public health emergency. During manufacturing, there are several risks to the quality of alcohol that could be transferred to any product(s) using this ingredient. Understanding the regulatory and quality requirements of the manufacture of ingredients helps companies ensure their ingredient quality.
USP is hosting the “Manufacturing Alcohol to Combat a Public Health Emergency: Insights on Regulatory and Quality Requirements” Open Forum. This two-day forum seeks to help manufacturers, distributors, and brokers, ensure quality of alcohol used in drug products, such as hand sanitizers.
The Forum will cover:
Wednesday, January 27
Presenters and Panelists from USP, FDA, and industry will address the regulatory and compendial requirements for manufacturing alcohol used in drug products, including:
- Applicable current good manufacturing practices (cGMP)
- Applicable information in FDA’s “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)” and FDA’s “Temporary Policy for Manufacture of Alcohol for Incorporation into Alcohol Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”
- Other regulatory and compendial requirements for manufacturing alcohol used in drug products
Thursday, January 28
Presenters will discuss USP’s services, programs, and standards available to help companies meet regulatory and quality requirements and differentiate their ingredients from competitors.
- USP’s Ingredient Verification Program
- USP monographs and reference standards
- Other USP services and program for manufacturing quality assurance
Presenters and panelists:
- Francis Godwin, Office Director, Office of Manufacturing Quality, FDA/CDER/OC
- Theresa Michele, Director, Director of FDA’s Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products
- Conner Curran, CEO/Managing Director, Dexterous DMCC (Dubai Multi Commodities Centre)
- Kristy Moore, Principal Scientist, KMoore Consulting, Growth Energy consultant
- Andy Powers, VP & Senior Consultant, Newton Enterprises, Inc
- Danita Broyles, Senior Market Development Manager, USP
- Stephen Andruski, Senior Manager, USP
- Bob Lafaver, Technical Service Manager, USP
- Robert Shimahara, Director, Strategic Customer Development - Americas
- Peter Claise, Director of Product Management, USP
Who should attend
- Pharmaceutical grade alcohol manufacturers
- Alcohol manufacturers new to manufacturing alcohol for use in drug products (e.g., fuel, distillery, etc.)
- Alcohol distributors and brokers
- Hand sanitizer companies interested in cGMP and other regulatory requirements for alcohol
To register or for further information, please contact Jacqueline D. Starkes.