FDA Regulatory Compliance for Hand Sanitizer Manufacturing

This 1.5 hour webinar is intended for industry professionals with interests in manufacturing and distributing topical consumer antiseptics (hand sanitizers or first aid antiseptics) in the US Market. This webinar will review the background of hand sanitizer topical antiseptic manufacturing and regulatory compliance in the United States in accordance with FDA temporary guidance and the FDA over-the-counter (OTC) monographs for consumer antiseptics. The presentation will discuss the recent updates to the USP monograph for alcohol, procedures for registering and submitting product listings, ensuring compliance with product labeling, and considerations for contract manufacturing and private listing distributors. Entities that intend to manufacture hand sanitizers beyond the four-ingredient World Health Organization formula outlined in the temporary guidance must be in compliance with the FDA Code of Federal Regulations Title 21 Parts 210 and 211 which outline the Current Good Manufacturing Practices (cGMP) for drug manufacturers. The speakers will provide a review of cGMP administrative and engineering controls required for achieving compliance with FDA cGMP.

Note: The course fee is per attendee. Recording the training course is strictly prohibited.

For registration questions please contact Kent Rader.

Elaine Strauss, PharmD, MS
Title: Senior Consultant, Cleanrooms and Sterile Compounding
WorkingBuildings Clinical Division

Dr. Strauss is a pharmacy leader with a demonstrated history of working in the hospital and healthcare industry. She provides a wide range of professional services to cGMP and sterile compounding pharmacy clients including expert opinion, regulatory assessment, gap analysis, SOP and workflow development, staff training and education to ensure compliance. Working with cGMP and industry manufacturing clients, Dr. Strauss provides regulatory expertise with FDA registration and product listing for topical consumer antiseptic products in accordance with FDA guidance and OTC monographs.

F. Kurt Last
Title: Executive Vice President and Practice Leader, cGMP/GTP & USP <797>/<800>/<825>
WorkingBuildings Clinical Division

Mr. Last has decades of experience with drug manufacturing plant operations where he led project management and quality assurance programs for a variety of academic and industry sites. He provides an extensive range of professional services to niche markets of CGMP, GTP and sterile compounding clients ensuring compliance with both FDA and USP regulations and standards. Mr. Last also serves as the subject matter expert for regulated manufacturing engineering controls and environmental monitoring at academic and medical centers across the United States.

Webinar topics

  • Manufacturers, contract manufacturing, private label distribution of consumer topical antiseptic products
  • Requirements for FDA establishment registration, labeler code application, and submission of national drug code (NDC) product listing files
  • Product labeling in accordance with FDA temporary guidance or FDA cGMP regulations
  • Overview of FDA Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
  • OTC Monograph for Consumer Topical Antiseptic Rubs: Final Rule: Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use
  • OTC Monograph for Topical Antimicrobial Drug Products: First Aid Antiseptic, Proposed Rule
  • Certificate of Analysis, ingredient overview, contaminant concerns, USP Monograph for Alcohol, ingredient testing in accordance with FDA guidance documents, FDA OTC Monograph, and USP monograph
  • cGMP Manufacturing Requirements, facilities and equipment, packaging and labeling systems, laboratory control systems, production systems
  • Supplier and vendor qualification procedures
  • Source ingredient, in-process manufacturing, and final batch testing
  • cGMP Quality System requirements, manufacturing, and batch documentation requirements
  • cGMP FDA Audit Readiness and SOP review
  • FDA hand sanitizer enforcement action summary
  • Register now


    Nov 10, 2020 -- Online
    1:00 PM Eastern time