ComplianceOnline

Understanding and Implementing USP <1058>: Analytical Instrument Qualification

Instructor: Dr. Ludwig Huber
Product ID: 700067
  • Duration: 78 Min

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$329.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

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 customercare@complianceonline.com 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
  • Instructor Profile:

    Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and 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 SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

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    Product Reviews Write review

    It’s great to get guidance from an expert on new regulations.
    - Anonymous

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