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The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been 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. This seminar will discuss all details and give strategies and case studies for easy implementation.
- Scope and principles of the new revision .
- Changes to the previous 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
- The importance of quality agreements between users and suppliers
- Integrating software validation and equipment qualification
- Dealing with changes of software, firmware and equipment hardware
- Recommendations for effective implementation of the new revision
Hand-outs and other Materials will be shared in the meeting.
- For easy implementation, attendees will receive 3 SOPs
- Analytical Instrument Qualification for <1058>
- Allocating Analytical Instruments to USP <1058>
- Procedures and deliverable for USP <1058>
- Pharmaceutical and medical device industry
- Manufacturers of drug substances (APIs)
- Contract laboratories
- Everybody using analytical instruments in FDA regulated environments
- Everybody using analytical data systems in FDA regulated environments
- Analysts and supervisors
managers and personnel
Ludwig Huber, Ph.D., is the director of Lab compliance and editor of Lab Compliance. He 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 CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies.