Please note that this training course will take place in person and has hands-on lab activities. Long pants and closed-toe shoes are required.
Controlling contamination in GMP classified areas requires much more than cleaning and disinfection. Operations need to assure that a complete system of control that starts with entry of components and personnel to the facility is established. This training course will identify and describe systematic elements essential to assuring an appropriate and compliant contamination control program for aseptic manufacturing facilities, classified and non-classified environments. This training course will also highlight the important aspects of PDA Technical Report No. 70 (TR70): Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities.
The training course covers the critical steps to developing and validating a complete contamination control program within controlled and non-controlled environments using chemical agents that reduce or destroy microorganisms. While sterile product manufacturing requires the most stringent application, the concepts introduced during the training course can also be used to design a program for the manufacture of non-sterile products.