Laboratory Controls – Anticipate the Systems Based FDA Inspection
September 6, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438/ 58
This training on laboratory controls will focus on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this webinar, you will fully understand how to prepare your laboratory for FDA. Many QA and QC personnel in the pharmaceutical industry are not familiar with the FDA systems-based inspection model. They are also not aware of the types of 483 observations that many FDA auditors make today. One of the most scrutinized areas during these inspections is the laboratory. Because of this, it is important for lab personnel to know the techniques used the FDA inspections during these types if audits. Knowing the systems, the FDA will look at is also key so that the lab can be properly prepared for the audit.