Faculty: Joy McElroy
The US Food and Drug Administration (FDA) expect that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. FDA’s findings of deficiencies concerning equipment validation indicate the agency expects definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate a wide range of deficiencies, and compliance is a moving target.
As with most regulatory challenges, the cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for equipment qualification and validation in your manufacturing facility?
In this 90-minute course, you will learn FDA and other global health authority expectations for equipment qualification, along with the development of a sound process validation program, which will allow you to develop and implement bullet-proof solutions that are accepted, effective, and efficient.
Areas Covered in the Session :
Who Should Attend: