New Revision of USP <1058>: Analytical Instrument Qualification

Date	Jul 25, 2018
Time	03:00 PM EDT
Cost	$15433.00
Online

Since the first version of USP <1058> was released, it has evolved to the global standard for analytical instrument qualification. August last year, a new revision was released with many new requirements mainly addressing the needs of quality systems, e.g., risk based implementation, quality agreements between service/system providers and users, and regular reviews to ensure ongoing performance and more. This seminar will discuss all details and give strategies and case studies for easy implementation.
Reference material for easy implementation:

• SOP: Analytical Instrument Qualification for <1058>
• SOP: Allocating Analytical Instruments to USP <1058> categories
• SOP: Procedures and deliverables for USP <1058> categories

Areas Covered in the Session :

• Changes to the previous chapter
• AIQ and its relation to method validation, system suitability testing and quality control checks
• Approaches for risk based qualification: where does risk assessment start
• The 4Q Qualification lifecycle approach: DQ, IQ, OQ, PQ
• Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• How to develop agreements with suppliers of equipment and service`?
• Requirements for outsourcing AIQ implementation
• Integrating software validation and equipment qualification
• Dealing with changes of software, firmware and equipment hardware
• Recommendations for effective implementation of the new chapter
• Expected timing of FDA enforcement

Who Should Attend:

• Laboratory managers and supervisors
• GLP/GCP/GMP auditors
• ISO 17025 auditors
• QA/QC managers and personnel
• Analysts and other laboratory staff
• Regulatory affairs
• Training departments
• Consultants