Analytical Instrument and Equipment Qualification in GXP and EPA Laboratories: USP 1058 and Beyond

This Laboratory compliance training will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. 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 (Good Laboratory Practices) labs supporting animal toxicology studies and GCP (Good Clinical Practices) labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated.

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.

Areas Covered in the seminar:

• Regulatory requirements for analytical instrument qualification.
• Calibration and Metrology Programs.
• USP < 1058>.
• ICH Q2.
• GXP.
• Equipment and Instruments - similarities and differences.
• Standards and Traceability.
• Documentation of instrument qualification.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.

• The employees who will benefit include: End-users responsible for testing
• QA managers and validation personnel
• Analytical development managers and personnel
• Senior Quality, Facilities and R&D Management
• Quality Control staff
• Quality system auditors