o Preparation for FDA Pre-Approval Inspections (PAIs)
o Attendance at FDA meetings
o Laboratory Control Systems, GLPs
o GMP Auditing ·
o Supplier Audit
o Quality System Development / Implementation
o Third Party Audit
o Change Control
o Stability Program Implementation
o Production Systems and Controls
o Packaging and Labeling· FDA Warning Letters
and FDA-483's
o Expert Testimony
