Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

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.

Why Should You Attend:

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.

Areas Covered in the Webinar:

• 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.

Who Will Benefit:

• Chemists
• Laboratory Managers
• Regulatory Affairs
• Quality Assurance personnel responsible for generating GMP or GLP data or assuring readiness for a regulatory inspection
• IT/IS
• Documentation