Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing.
This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. The impact of USP <1058> on analytical instrument qualification will be reviewed and the newest regulation will be presented in a simple and understandable way. The interaction of calibration, qualification, method validation and equipment maintenance on laboratory compliance and data quality will be discussed.
Why should you attend: The analytical instruments and laboratory equipment are easy targets for inspectors looking to cite observations of non-compliance. Are yours ready for the internal QA and external regulatory inspectors?
Areas Covered in the Session: - Regulatory requirements for analytical instrument qualification
- Calibration and Metrology Programs
- USP <1058>
- ICH Q2
- GXP
- Equipment and Instruments - similarities and differences
Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include:
- QC managers and personnel
- QA managers and personnel
- Information Technology managers and personnel
- Validation specialists
- Facility staff
