ComplianceOnline

Understanding and Implementing USP <1058>: Analytical Instrument Qualification

Instructor: Dr. Ludwig Huber
Product ID: 700067
  • 15
  • February 2018
    Thursday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 75 Min

Live Online Training
February 15, Thursday 10:00 AM PST | 01:00 PM EST | Duration: 75 Min

$139.00
$199.00 (30%)
Save $60.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$249.00
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 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

Customer Care

Fax: +1-650-362-2367

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

    Dr. Ludwig Huber
    Director and Chief Editor, Labcompliance

    Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber 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.

    Follow us :
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    Refund Policy

    Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

    Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

    If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

    We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

    Product Reviews Write review

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

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