Analytical Instrument Qualification - Practical Approaches for Revised USP General Chapter <1058> Compliance
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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.
Objectives of the Presentation
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)
Outline
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
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Onlinecompliancepanel is a dedicated team of youngsters, who work in tandem with the latest US FDA regulations/regulatory compliance in creating training sessions suitable for individuals and corporations. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Our interactive training sessions could be beneficial to corporations thriving in industries such as pharmaceuticals, drugs and chemicals, FDA compliance, medical devices, packaging and labeling, food and beverages, banking and finance, audits and inspections, recalls and crisis management and many more. We emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices, risk management and market trends.
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
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