• designate a director before the study begins
• assure there is a quality assurance unit
• replace director if need be
• assure all test and control articles have been tested
• assure the personnel clearly understands the functions they are to perform

responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformances with the regulation in this part

determine that no deviations from approved protocols or standard perating procedures were made without proper authorizations and documentation

• shall have education, training, an experience, or combination thereof, to enable that individual to perform the assigned functions
• maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study
• wearing proper clothing
• sufficient number of personnel for duration of the study according to protocol
• if there is someone who will affect the results of the study they should be excluded