Drug OTC GMPs and Labeling
A Five-Part Virtual Seminar Series
Presented by Lisa El-Shall, Victoria Pankovich, Jeb Hunter
Tuesdays in June 2026
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
June 2, 2026
1pm Eastern Time (1-hour session)
Presented by Victoria Pankovich
Adverse Events Reporting
June 9, 2026
1pm Eastern Time (1-hour session)
Presented by Lisa El-Shall and Victoria Pankovich
OTC Labeling and Monographs
June 16, 2026
1pm Eastern Time (1-hour session)
Presented by Lisa El-Shall and Victoria Pankovich
Compliance Inspection Enforcement
June 23, 2026
1pm Eastern Time (1-hour session)
Presented by Lisa El-Shall
Private Label Distributor Requirements
June 30, 2026
1pm Eastern Time (1-hour session)
Presented by Jeb Hunter
Instructors
Lisa El-Shall
Senior Director for Pharmaceutical and
Device Consulting Services
Lisa El-Shall has a B.S. in Chemistry from the University of North Carolina at Chapel Hill and a M.S. from the University of California, Los Angeles in Biochemistry. She has extensive experience in a Consumer Healthcare organization in both Research and Development and Quality and has held leadership positions in the analytical laboratory and quality. For the past 11 years she led the Research and Development Quality group at Pfizer and GSK with global responsibility for areas including development, clinical supply production/release, clinical study oversight, and business development quality. She has proven ability in establishment, implementation, and maintenance of fit for purpose standards, systems, and Regulatory Inspection compliance.
Victoria Pankovich
Manager, Regulatory Services
Reporting to the Senior Director Pharmaceutical & Medical Device Consulting, Victoria Pankovich supports clients through assembling and processing FDA submissions including Drug Master Files, Abbreviated New Drug Applications and New Drug Applications. Serve as the primary US Agent for all required communications with FDA on behalf of clients, including Establishment Inspection coordination with FDA, Drug, Medical Device and Food facilities registration; Drug and Medical Device product listings; Color Certification requests; FDA Inspection Notifications; FOl and FDA Controlled Correspondence requests.
Jeb Hunter
EAS Senior Regulatory Consultant
Jeb S. Hunter holds a BS in Microbiology from Clemson University and has spent his career in Quality, starting in a microbiology and chemistry laboratory setting and moving into auditing and managing Quality Management Systems. Jeb has experience in the Pharmaceutical, Medical Device, Dietary Supplement, and Food/Tobacco industries. He is a highly capable team auditor and Lead Auditor across auditing platforms with audits conducted against a host of regulatory standards both domestic and international.
Registration
Registration for this event is for all 5 session.
All seminar registrations are per person.
On-line Training
The EAS Consulting Group Food and Dietary Supplement Labeling Seminar will be conducted virtually through Zoom. A link will be provided to each participant. To ensure an understanding with the instructional material, live student attendance and active participation in discussions via webcam is required. At the conclusion of the training, students must complete a labeling exam with an acceptable score in order to receive their certificate of training.
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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For More Information or Questions
Contact Jessica Lloyd at (571) 447-5508 or trainings@easconsultinggroup.com
In-House Seminar
EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact us for a price quote. (571) 447-5500.
All EAS seminars and webinars are delivered in a virtual format unless an event specifically notes in-person details. Virtual delivery allows attendees to participate from any location while still engaging directly with our instructors. Please verify your schedule prior to registration. Attendance at each seminar date is expected.