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 or if problems are encountered, and periodically as necessary. FDA requirements for qualification and validation will be discussed.
Lack of adequate qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, including information technology (IT) and manufacturing and cleaning process validation will benefit from a review of the relevant FDA rules, written and unwritten. Those involved in hosting FDA inspections will also benefit.
Areas Covered in the Session :
General FDA GMP information requalification and validation
Equipment Qualification
IQ
OQ
PQ
Computer System Qualification and Part 11
Manufacturing and Cleaning Process Validation
Specifications
When to test
What to test
How much to test
Who Should Attend:
Personnel responsible for equipment qualification
Personnel responsible for computer system qualification
Personnel responsible for manufacturing process validation
Personnel responsible for cleaning validation
Regulatory Affairs, Regulatory Compliance
Quality Professionals