This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.
This USP < 1058> webinar will give a good understanding of current and future FDA requirements and the USP framework. It also will provide detailed steps, examples and tools for cost-effective implementation.
Why Should You Attend:
Analytical instruments should be qualified to demonstrate suitability for the intended use. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there was no clear standard with details for equipment qualification. This has changed. The USP has developed a chapter that provides a framework for analytical instrument qualification (AIQ).This USP < 1058> webinar will give a good understanding of current and future FDA requirements and the USP framework. It also will provide detailed steps, examples and tools for cost-effective implementation.
Areas Covered in the Webinar:
- 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).
- Free Hand-outs :
- For easy implementation, attendees will receive
- Copies of all slides
- SOP: Analytical Instrument Qualification
- SOP: Allocating Analytical Instrument to USP < 1058> Categories
- SOP: Procedures and Deliverables for Qualification of USP < 1058> Instrument Categories
- 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:
- (Bio)Pharmaceutical Companies
- Manufacturers of drug substances (APIs)
- Contract laboratories
- Everybody involved in analytical instrument qualification
- Laboratory Managers
- QA managers and personnel
- Analysts
- Metrology groups
- Validation specialists
- Suppliers of analytical equipment
- Regulatory affairs
- Training department
- Consultants
Course Content
- 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).
Speaker
Dr. Ludwig HuberCourse Provider
Dr. Ludwig Huber,
