Understanding the new revision of USP chapter 1058: Analytical Instrument Qualification

Why Should You Attend:

The first version of USP <1058> has been released in 2008. Since then it has evolved as the golden 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. And 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 seminar will help to understand the differences to the existing version. This seminar will discuss all details and give strategies and case studies for easy implementation.

Areas Covered in the Webinar:

• Terminology, 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
• Dealing with three instrument categories A, B and C
• Procedures and validation deliverables for the three categories
• Requirements for outsourcing AIQ
• The importance of the quality agreement between users and suppliers
• Roles and responsibilities: Quality unit, manufacturer, user
• Integrating software validation and equipment qualification
• Integrating the USP 1058 revision with the GAMP Guide on Laboratory Computerized Systems

Handouts:

For easy implementation, attendees will receive three SOPs

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

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

Who Will Benefit:

• Laboratory managers and staff
• Analysts
• QA managers and personnel
• Regulatory affairs
• Training departments
• Documentation department
• Consultants
• Validation specialists

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

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