Scientifically Valid: Laboratory Operations Testing Practices are Becoming a Major Focus for FDA
FDA's use of the term "Scientifically Valid" as it applies to test methods and examinations has raised questions in recent years and has created uncertainty on how to comply with the cGMP regulations for Dietary Supplements. As FDA scrutiny increases and companies are required to test their products throughout the manufacturing process, the reliance on scientific data and laboratory analysis is increasing. This also leads to increased reliance on third party laboratories. In doing so, the span of control for assuring that the appropriate methods are being used is becoming blurred.
In this webinar, we will focus on the following key items:
- Defining the term Scientifically Valid in the context of the cGMP requirements
- The importance of partnering with a well-renowned contract laboratory
- Step you should take to maintain the control of the laboratory operations and to ensure that the methods are appropriate for the products being tested.