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:
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.
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...
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