Analytical Instrument Qualification According The New Revision of USP 1058
The first version of USP <1058> has been released in 2008. Since then it has evolved as the global standard for analytical instrument qualification, despite of some deficiencies of the first version.
For example, the industry had difficulties to apply the chapter for systems comprising equipment hardware and computer systems. In addition, there have always been comments about not enough details for the four qualification phases. These deficiencies have been clarified in the new revision with much more details on integrated systems but still some interpretation is required for compliant and efficient implementation. This webinar will discuss all details and give strategies and case studies for easy implementation.
Areas Covered in the Session:
- Scope and principles of the new revision.
- Changes to the existing chapter
- Approaches for risk based qualification
- The 4Q Qualification lifecycle approach: DQ, IQ, OQ, PQ
- Purpose and contents of qualification phases: DQ, IQ, OQ, PQ
- Dealing with three instrument categories A, B and C
- Procedures and validation deliverables for the three categories
- The importance of the quality agreement between users and suppliers
- Integrating software validation and equipment qualification
- Integrating the USP 1058 revision with the GAMP Guide on Laboratory Computerized Systems
- Dealing with changes of software, firmware and equipment hardware
- Recommendations for effective implementation of the new revision
For Easy Implementation, Attendees Will Receive:
- Analytical Instrument Qualification for <1058>
- Allocating Analytical Instruments to USP <1058> categories
- Procedures and deliverables for USP <1058> categories
Who Will Benefit:
- QC managers
- QA managers and personnel
- Analysts and lab managers
- QA managers and personnel
- Regulatory affairs
- Training departments
- Documentation department
- Consultans