Quality Assurance

List of tables

1.1	FDA predicate rules for written SOPs	10
1.2	Correspondence between roles and observations	12
1.3	The routine review of life-cycle documents	16
1.4	Fields in typical Notice of Event form	19
1.5	Elements of CAPA	20
1.6	FDA predicate rules for adverse events	26
1.7	FDA predicate rules for complaint files	28
2.1	Illustrative production observations that will be escalated	39
2.2	Illustrative lab observations that will be escalated	39
2.3	Illustrative observations that will be triaged	40
2.4	Reason’s models of human error	44
2.5	Format of final investigation report	46
2.6	Format of investigation summary	46
2.7	Elements of the program logic model	48
3.1	Measuring the complexity of lab tests	61