GMP training

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:

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:

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.
For More Details:

Email: david@grcts.com
Tel: +1-248-233-2049
Web: www.grcts.com