(571) 447-5500

Drug OTC GMPs and Labeling

A Five-Part Virtual Seminar Series

Drug OTC GMPs and Labeling Seminar

Presented by Lisa El-Shall, Victoria Pankovich, Jeb Hunter and Norma Skolnik

June 4, 11, 18, 25, and July 16 2024

If you manufacture products in the OTC-drug space, including homeopathic, the challenges of FDA regulatory requirements become confusing. With a mixture of regulations spanning pharmaceutical Good Manufacturing Practices (GMPs) per 21 CFR Part 210 and 211 for pharmaceuticals, and proscriptive monographs categorized by therapeutic classes, covering labeling and claims, as well as registration and listing requirements under 21 CFR 207, these nonprescription products are held to intense scrutiny.

EAS’s five-part series on OTC GMPs and Labeling Compliance covers what you need to know to manufacture and market your products in accordance with FDA requirements. Covering inspection enforcement, labeling requirements, private label distributors, registrations and listings of your facilities and products as well as how to design an effective Adverse Events Reporting program, our team of experts will help you to understand what is required and how to comply.

OTC Labeling and Monographs

June 4, 2024, 1pm Eastern Time (1-hour seminar)

Presented by Norma Skolnik

Adverse Events Reporting

June 11, 2024, 1pm Eastern Time (1-hour seminar)

Presented by Victoria Pankovich and Lisa El-Shall

Registration and Listing Requirements

June 18, 2024, 1pm Eastern Time (1-hour seminar)

Presented by Victoria Pankovich

Compliance Inspection Enforcement

June 25, 2024, 1pm Eastern Time (1-hour seminar)

Presented by Lisa El-Shall

Private Label Distributor Requirements

July 16, 2024, 1pm Eastern Time (1-hour seminar)

Presented by Jeb Hunter

New Dates to be Announced

Want to be the first to know of the new dates of the next seminar? Add your name and email address to be added to the notification list.


Two or more registrants from same company – 10% (use GROUP10 discount code at checkout)

Federal or state employees – 50% discount (use GOV50 discount code at checkout)

* only one discount code may be used


Cancellations will be refunded minus a $25 processing fee up to two weeks prior to the start date of the seminar. After this date, no refunds will be given.

Terms and Conditions
By submitting this form you will be joining the nearly 20,000 who receive the monthly EASeNews regulatory newsletter. Please note EAS never shares your information and you may unsubscribe at any time.

Posted in Drugs, Seminar.