Laboratory Inspection Readiness – Implementing GMPS for the Pharmaceutical Laboratory
Thursday, December 6, 2012 from 10:00 AM to 12:00 PM (PST)
Palo Alto, CA
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 this 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.
Date: December 06, 2012
Time: 10:00 AM-12:00 PM PDT
Cost: $349 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.