CGMPs in the Quality Control Laboratory (Medical 2018)

When: Fri., Sept. 14, 10-11:30 a.m. 2018

Overview: Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.