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.

Areas Covered in this Webinar:

1. Types of Inspections.
2. Personnel Organization and Records.
3. Instrument Inventory, Qualification and Change Control.
4. Key SOPs Every Lab Should Have, and Related Training and Maintenance.
5. Log of Out of Specification Results.
6. Documentation of Analytical Procedures, including Validation, Verification and Change Control.
7. Documentation of Analytical Data and Reports.
8. Trending of Analytical Data, Laboratory Incidents and OOS Reports.
9. Brief Introduction to Expectations for Computer Systems.
10. 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