ComplianceOnline

FDA Regulations for Marketing OTC Drugs in the U.S.

Instructor: Norma Skolnik
Product ID: 704145
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2016

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.

Why Should You Attend:

Understanding U.S. FDA regulations and the OTC monograph system and its labeling requirements will help companies assure compliance and enable those who want to market U.S. drug products to make optimal OTC label and promotional claims. It will also help those who attend avoid FDA issues, U.S. importation problems, and FDA warning letters. Helpful regulatory tools and references (including website references) as well as know-how tips will be provided.

Areas Covered in the Webinar:

  • Basic U.S. OTC drug labeling requirements
  • OTC drug monographs and their importance in drug labeling compliance
  • FDA drug facts labeling regulations
  • How to use the OTC monographs to achieve the best product labeling
  • FDA serious adverse event reporting label requirements

Who Will Benefit:

  • Regulatory affairs managers, directors and associates
  • Compliance specialists
  • Marketing managers
  • Anyone planning to market, label or promote OTC drug products in the U.S.

Instructor Profile:

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as director of regulatory affairs for the Americas for Cadbury Adams. Prior to that, she was director of regulatory affairs for the Adams Division of Pfizer and associate director of regulatory affairs for the Warner-Lambert company. She also served as director of regulatory affairs for Lederle Consumer Healthcare and as associate director of marketed product support for Lederle Laboratories and associate director of regulatory affairs for Wyeth.

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Upcoming In-person Seminars by EX-FDA OFFICIALS

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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