FDA Enforcement Priorities: Why OTC Drugs & Dietary Supplement Firms Get FDA Warning Letters

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
60 minutes
Product Description

FDA Warning Letters Can Pose Serious Threats to Drug Approval Requests or Export Certificates of an Organization. Know The Reasons and Learn How to Avoid Them!

An FDA Warning Letter can have serious consequences for any drug or Dietary Supplement firm. Once the letter is issued, there will be a statement which implies the award for federal contracts. If cGMP violations are cited, for example, a statement concerning the potential impact on approval requests of drug applications and export certificates will be provided.

This webinar by expert speaker Norma Skolnik will address the various reasons why OTC drug and Dietary Supplement companies get FDA Warning Letters, the trouble they can cause, and discuss ways to avoid them.Furthermore, this conference will assist you in understanding:

  • Citations to all relevant FDA regulations
  • Relevant FDA website references
  • Know-how tips on marketing OTC drugs & Dietary Supplements in compliance with FDA regulations
  • Actual FDA Warning Letters sent to drug & supplements firms, as examples

Session Highlights:

  • What Are FDA’s Current Enforcement Priorities?
  • What are FDA Warning Letters and What Are its Implications?
  • FDA Warning Letters based on Product or Quality issues
  • FDA Warning Letters based on false or illegal claims
  • Warning letters issued by FDA based on labeling issues
  • Avoid getting a FDA Warning letter
  • What to do if you receive a Warning letter/ How to manage the situation

Who Should Attend

Regulatory Affairs managers and associates, QA mangers, OTC Drug & Dietary Supplement Marketing managers, attorneys, and anyone interested in learning about how to avoid FDA Warning letters.

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About Our Speaker

Norma Skolnik - FDA Regulations Expert

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...   More Info
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