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Drug OTC GMPs and Labeling

A Five-Part Virtual Series

Presented by Bryan Coleman, Senior Director of Pharmaceuticals and Medical Devices; Victoria Pankovich, EAS Regulatory Specialist; Norma Skolnik, EAS Independent Consultant; and Bruce Elsner, EAS Independent Consultant

February 2, 9, 16, 23, and March 2, 2022

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 110 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.

Join us beginning February 2, 2022, for five weeks from 12-1pm eastern. Our team of regulatory experts will lead you through the important foundational steps of FDA compliance.

February 2: Compliance Inspection Enforcement

Presented by Bryan Coleman, Senior Director Pharmaceuticals and Medical Devices

February 9: OTC Labeling and Monographs

Presented by Norma Skolnik, EAS independent consultant 

February 16: Private Label Distributor Requirements

Presented by Bruce Elsner, EAS independent consultant

February 23: Registration and Listing Requirements

Presented by Victoria Pankovich, Regulatory Specialist

March 2: Adverse Events Reporting

Presented by Norma Skolnik, EAS independent consultant

Registration

Cost: $249
$199 for EAS, Certified Group and FSNS Clients

* discounts may apply

$199.00$249.00

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Discounts

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

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.

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Posted in Drugs, Seminar.