Who Should Attend
This online training will benefit laboratory personnel in all FDA regulated industries. Although the focus is the pharmaceutical industry, the concepts and practices apply to any laboratory operating in any FDA regulated environment, including industries: such as: Pharmaceutical, Biotechnology, Medical Device, Chemical Processing, Food, Cosmetics.
Positions that will benefit include:
• Laboratory Management
• Supervisors
• Chemical Analysts
• Microbiologists in Quality Control
• Quality Assurance
• Product Development
Description
This course will be available On Demand: January 9, 2014
In this 90-minute accredited training, we will discuss Laboratory Controls, which are identified in Subpart I of the GMPs. The focus in this discussion will be on the aspects of the laboratory operation identified in the FDA system based inspection guidances. The elements identified in these guidances cover all aspects of the laboratory operation and represent areas where the FDA is directing its attention, and therefore, present the greatest risk to the pharmaceutical Quality Control Laboratory. The discussion will help the participant focus on the high risk areas of the laboratory operation and minimize the risk of FDA observations.