Analytical Instrument Qualification - Practical Approaches for Revised USP General Chapter <1058> Compliance

Duration: 90 Minutes
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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 webinar will discuss all details and give strategies and case studies for easy implementation.
Analytical Instrument Qualification
Instructor: Gregory Martin
Product ID: 509717
Objectives of the Presentation
  • What the new USP general chapter contains
  • FDA and EU requirements for analytical instrument qualification
  • Most common inspection problems
  • Terminology, scope and principles of the new USP chapter
  • AIQ and its relation to method validation, system suitability testing and quality control checks
  • Essential steps for AIQ: DQ, IQ, OQ, PQ
  • Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • Recommendations for firmware and software validation
  • Roles and responsibilities: QA, manufacturer, user
  • Approach for automated systems (incl. firmware/computer systems)
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
Why Should you Attend
Calibration and qualification of equipment are key requirements in GMP guidelines. These requirements also apply to instruments and systems in analytical laboratories of the pharmaceutical industry. Besides calibration and qualification, the validation of computerized systems is another key issue.

The objective of this course is to provide the participants with an overview of the regulatory requirements on the qualification of analytical equipment and the software validation of computerized systems and to give practical advice on successful approaches to calibration, qualification, validation, and routine monitoring of instrumentation and systems. Key requirements of the important USP General Chapter <1058> will be presented and discussed.

Areas Covered
  • 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
Who will Benefit
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Training personnel
  • Validation specialists, scientists, engineers
$375
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Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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