Drug OTC GMPs and Labeling
A Five-Part Virtual Seminar Series
Presented by Lisa El-Shall, Victoria Pankovich, Jeb Hunter
May 6, 13, 20, 27, and June 3, 2025
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.
Registration and Listing Requirements
May 6, 2025, 1pm Eastern Time (1-hour session)
Presented by Victoria Pankovich
Adverse Events Reporting
May 13, 2025, 1pm Eastern Time (1-hour session)
Presented by Lisa El-Shall and Victoria Pankovich
OTC Labeling and Monographs
May 20, 2025, 1pm Eastern Time (1-hour session)
Presented by Lisa El-Shall and Victoria Pankovich
Compliance Inspection Enforcement
May 27, 2025, 1pm Eastern Time (1-hour session)
Presented by Lisa El-Shall
Private Label Distributor Requirements
June 3, 2025, 1pm Eastern Time (1-hour session)
Presented by Jeb Hunter
Registration
Registration for this event is for all 5 session.
$199.00 – $249.00
Discounts
Two or more employees from the same firm will receive a 10% discount, auto applied in cart within the same transaction.
Federal and State Employees may be eligible for a 50% discount. Contact Jessica Lloyd for more details.
* Only one discount code per transaction
Cancellation Policy
EAS reserves the right to cancel the seminar if minimum participation has not been met two weeks prior to the start of the seminar. All registrations will be refunded in full.
Cancellations will be refunded minus a $95 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
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