Description:This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
Course Objective:This laboratory inspection course is designed to provide participants with an understanding of the areas which are likely to be the subject of a laboratory inspection, whether it is a Pre-Approval Inspection or a general GMP inspection. By understanding the expectations, the participants will be able to develop a strategy to minimize issues should their laboratory be inspected.Upon completion of this course the participant should:Be familiar with the areas in which regulatory inspectors are likely to probe.Be aware of the general expectations for each of these areas.Develop an overall strategy to minimize the likelihood of issues arising during an inspection.Due to the diverse interests of the participants, questions will be actively solicited and addressed by the end of the webinar
Course Outline:Types of Inspections.Personnel Organization and Records.Instrument Inventory, Qualification and Change Control.Key SOPs Every Lab Should Have, and Related Training and Maintenance.Log of Out of Specification Results.Documentation of Analytical Procedures, including Validation, Verification and Change Control.Documentation of Analytical Data and Reports.Trending of Analytical Data, Laboratory Incidents and OOS Reports.Brief Introduction to Expectations for Computer Systems.Attendee Questions and Answers.