Dr.Loren Gelber

This webinar will include things that it is important to know about FDA inspections. Using the self-auditing process to correct problems before the FDA or customer arrives will be discussed. How to prepare for an FDA inspection and how to behave during one wil ...

This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research information will be pr ...

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made o ...

This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research information will be pr ...

FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they ...

This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do.

Definitions of prescription (Rx) and OTC drugs will be presented. The three ways that FDA regulates OTC drugs, Monographs, Applications and Rx to OTC switches, will be discussed. Labeling rules for OTC products will be reviewed. Other requirements, including R ...