Establishing a Contamination Control Program for FDA Regulated Industry

This seminar will discuss the various areas and methods of preventing and controlling contamination in a GMP environment. It will elaborate on risk assessment and establishing critical control points in facility, utilities, personnel and material flows, and process design. Moreover this course will discuss the criteria to consider when establishing  material specifications, process specifications, final product specifications, and testing. Major contamination issues such as biofilms will be discussed and cleaning validation and disinfectant qualification criteria will be discussed.