This one-day intensive program will discuss FDA’s current Good Manufacturing Practice (GMP) requirements for Research and Development and Quality Control Laboratories. The course will cover GMP regulations for physical, analytical, and microbiological laboratories including analyst training and qualification; the labs’ physical facility and environment; instrument qualification, calibration and maintenance programs; laboratory sample control processes; the management of standards and chemicals; the management of data; and overall laboratory documentation. The development, verification, validation, control, and use of test methods as well as transfer thereof will also be discussed. An entire session will be dedicated to the performance of thorough, timely, unbiased, well-documented, and scientifically sound Out-of-Specification (OOS) investigations since this is one of the most critical laboratories quality systems. Tips regarding establishing quality agreements with clients and handling the FDA during an inspection will also be provided.
FDA issues of concern will be highlighted throughout the program with emphasis placed on recent FDA regulatory or administrative actions. All of this will allow participants to gain an understanding of the importance of laboratory GMPs and how to meet FDA’s requirements.
Date and Location
April 23, 2019
Hilton Garden Inn Denver Downtown
1400 Welton St.
Denver, CO 80202
Tara Lin Couch, Ph.D., Senior Director, Dietary Supplement and Tobacco Services