ComplianceOnline

Meeting FDA Requirements for Over-the-Counter / OTC Drug Labeling

Instructor: Alfredo J Quattrone
Product ID: 701229
  • Duration: 60 Min

recorded version

$299.00
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: Mar-2009

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

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Email: customercare@complianceonline.com

Read Frequently Asked Questions

This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.

Why Should You Attend:

Over-the-Counter (OTC) Drug products do not require medical prescriptions, but must meet the respective FDA Drug Monograph requirements published in the Code of Federal Regulations (CFR), and thus the labeling of OTC Drugs differs substantially from that of labeling for all other drug (i.e., prescription) products. I will contrast the difference in the labeling of OTC & NDA drugs; I will present example OTC labels that the FDA deems acceptable; I will provide a few examples of firms that have deviated from FDA’s labeling for OTC products (some of which were likely cases of fraud); and I will answer questions dealing with correct labeling.

Areas Covered in the seminar:

  • What are FDA's labeling requirements that differ between NDA vs. OTC Drug Labeling.
  • Compliance parameters within FDA's 21 CFR 201 (esp. 201.66) and related sections crucial..
  • Goals of FDA's Inspectors in reviewing open market & internet OTC labeling & advertising..
  • Examples of acceptable OTC drug labeling.
  • Examples of unacceptable OTC drug labeling.
  • Enforcements due to illegitimate OTC drug labeling.

Who will benefit:

This webinar will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales. The employees who will benefit include:

  • OTC drug manufacturing personnel responsible for OTC drug product labeling
  • QA managers and personnel
  • OTC drug operations managers and personnel
  • Validation specialists
  • Consultants
  • Quality system auditors

Instructor Profile:

Alfredo J Quattrone, Prior to retiring in Dec 2006, Alfredo Quattrone, PhD, served in the Food and Drug Branch (FDB) of the California Department of Health Services for 19 years as a Staff Toxicologist, assisting with inspections of drug and device manufacturers within CA. During his last 8 years at FDB, Dr. Quattrone directed the State's team for FDA's accredited 3rd party persons medical device review unit, providing direct review support for 36+ device clearances for 510k premarket notification (PMN) submissions to FDA. Dr. Quattrone also coordinated the CA DHS Export Document program for processed foods & dietary supplements, medical devices, and drugs manufactured in California. Since early 2008, Dr. Quattrone has served as a consulting senior scientist affiliate to Auk Technical Services, Inc.

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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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