grc training solutions n.
Skip this Video
Download Presentation
Live Webinar On FDA Regulation of GMPs for OTC Drugs

Loading in 2 Seconds...

play fullscreen
1 / 5

Live Webinar On FDA Regulation of GMPs for OTC Drugs - PowerPoint PPT Presentation

  • Uploaded on

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
Download Presentation

PowerPoint Slideshow about 'Live Webinar On FDA Regulation of GMPs for OTC Drugs' - GRCTS

Download Now An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
grc training solutions
GRC Training Solutions

Contact Us



  • This webinar will cover FDA laws and regulations for Current Good Manufacturing Practices (CGMPs) for OTC Drugs in the U.S.A.  The presentation will provide an overview of FDA regulations for CGMP compliance and will help the attendee understand basic CGMP regulatory requirements and FDA enforcement priorities. 
objectives of topic
Objectives of Topic:
  • a. To gain an understanding of current Regulatory requirements for CGMP compliance for OTC drugs in the U.S.;
  • b. To understand what are FDA’s enforcement priorities regarding CGMPs;
  • c. to learn how to implement FDA CGMP requirements;
  • d. To gain an understanding of the importance of company responsibilities regarding CGMPs for OTC drugs in the U.S.
areas you will be touching during the session
Areas you will be touching during the Session:
  • a. FDA’s general provisions for CGMPs.;
  • b. FDA requirements for organization and personnel;
  • c. CGMP requirements for buildings & facilities;
  • d. CGMP requirements for equipment;
  • e. Production & process control requirements;
  • f. Packaging & labeling control requirements; Records & Report requirements under FDA CGMPs.
  • Industries that will benefit from your training.: OTC Drug companies, Consumer Healthcare Product companies
instructor profile
Instructor Profile:
  • Norma Skolnik has over 35 years of U.S. regulatory experience, starting in the pharmaceutical industry.  She was Associate Director of Regulatory Affairs at Lederle Laboratories in Pearl River, N.Y. and then became Associate Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum and Caltrate dietary supplements.  When Lederle was acquired by Wyeth, she became Associate Director of Regulatory Affairs there, acquiring more experience in the Dietary Supplement and OTC drug fields.  She joined Warner-Lambert Consumer Health division in 1998 and became Assistant Director of Adams Regulatory Affairs.  In 2002 after Pfizer’s takeover of Warner-Lambert, she was promoted to Director of Regulatory Affairs for the Adams division.   Adams was acquired by Cadbury-Schweppes in 2003 and she served as Cadbury Adams’ Director of Regulatory Affairs for the Americas from 2003 until her retirement in 2008. Norma earned a Bachelor’s degree in Biology from the University of Cincinnati and holds a Master’s degree from Pratt Institute in Brooklyn, New York. She's also done graduate work at Columbia University and Montclair State University. Today Norma works as a regulatory consultant to FDA regulated companies and to firms who wish to launch products in the U.S.A.