Overview: This Interactive webinar will begin with an overview of the GMP/GLP requirements for an Equipment system.
The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/GLP compliance will be reviewed.
Why you should attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories.
Areas Covered In the Seminar:
* FDA requirement for Equipment systems
* Overview of GMP/GLP requirements for equipment
* IIQ/OQ/PQ of Equipment
* Equipment database
* Equipment SOPs
* Equipment Calibration and maintenance
* Review of equipment related citations in recent Warning Letters
Who will benefit: This course is intended to provide training how to perform OOS/OOT investigations
* QC Supervisors and Management
* QA personnel
* QA Management
* Documentation management specialists
* Regulatory affairs personnel
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/GLP compliance will be reviewed.
Why you should attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories.
Areas Covered In the Seminar:
* FDA requirement for Equipment systems
* Overview of GMP/GLP requirements for equipment
* IIQ/OQ/PQ of Equipment
* Equipment database
* Equipment SOPs
* Equipment Calibration and maintenance
* Review of equipment related citations in recent Warning Letters
Who will benefit: This course is intended to provide training how to perform OOS/OOT investigations
* QC Supervisors and Management
* QA personnel
* QA Management
* Documentation management specialists
* Regulatory affairs personnel
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
