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Equipment Qualification, includes recommendations for test parameters acceptance criteria

Horacio Pappa: <1058>, Analytical Instrument Qualification, Status and content.  

 

 

 

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 333

Laboratory Equipment Calibration and Qualification according to USP <1058> 

With SOPs, Templates and Examples for easy Implementation

Recorded, available with all reference material at any time

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Calibration and qualification of equipment are key requirements of FDA and equivalent international al regulations and guidelines, In the last couple of years USP <1058> became the global golden standard for analytical instrument qualification and calibration. The principle has also been applied for other laboratory equipment. FDA and international inspectors refer to its qualification principles for GMP assessment  of laboratory equipment . But still today companies struggle with implementation because <1058> does not really give specific advice on 'how to' qualify laboratory instruments.

Key Questions related to USP <1058> lab equipment:

  • What do FDA and other regulations say about laboratory equipment qualification?
  • What exactly are the expectations of inspectors?
  • When is 1058 mandatory, even so the chapter number is above 1000?
  • How can we apply 1058 to all laboratory equipment?
  • What qualification model does the USP standard follow?
  • How to systematically define instrument categories A, B and C?
  • What steps are included in analytical instrument qualification?
  • Which procedures should be available for the three categories?
  • Which qualification documents should be generated for each category?
  • We already have procedures for equipment qualification and calibration, should we change them?
  • What exactly should be in each qualification phase: DQ, IQ, OQ, PQ?
  • What and how much should be tested?
  • How to qualify firmware?
  • What to test after changes, e.g., when the equipment is moved, repaired or updated?
  • How to implement the standard most effectively?
  • How can existing instruments be qualified?
  • Where can we get real examples for equipment qualification?
  • How should I document instrument qualification?
  • When is the next USO 1058 revision coming and what will be the changes?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • FDA and EU laboratory equipment requirements
  • Most common inspection problems
  • Terminology, scope and principles of US chapter <1058>.
  • AIQ and its relation to method validation, system suitability testing and quality control checks
  • Essential steps for laboratory equipment qualification : DQ, IQ, OQ, PQ
  • Purpose and contents of design qualification, installation qualification, operational qualification, performance qualification
  • Allocation of instruments to the three categories A, B and C
  • Procedures and validation deliverables for the three categories
  • Recommendations for firmware and software validation
  • Integrating equipment and computers to system validation
  • Roles and responsibilities: QA, manufacturer, user
  • Qualification of existing systems
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • Integrating USP 1058 with the new GAMP Guide on Laboratory Computerized Systems
  • Recommendations for effective implementation
  • The future of <1058>: Proposed changes

And for easy and instant implementation:
download 10+ documents from special seminar website

  • 10 examples SOPs
    - Analytical Instrument Qualification for <1058>
    - Allocating Analytical Instruments to USP <1058> categories
    - Procedures and deliverables for USP <1058> categories
    - User Requirement Specifications (URS) for analytical equipment
    - Change control for analytical equipment
    - Qualification of equipment
    - Qualification of analytical balances
    - Qualification of refrigerators
    - Development and maintenance of test scripts for analytical systems
    - Validation of laboratory computer systems
  • Examples/templates:
    - Validation plan, URS, DQ
    - Vendor assessment
    - IQ, OQ, PQ
    - Validation summary report
  • Warning letters and Inspectional observations related to laboratory equipment qualification.
  • Publications
    -:Equipment Qualification in Practice
    - Selecting parameters and limits for equipment operational qualification
  • FDA Presentation on Equipment Qualification, includes acceptance criteria
  • USP presentation: <1058> Analytical Instrument Qualification
  • Slides of the presentation as PPT files to train others
  • Script of the presentation
  • All questions and answers from before, during and after the seminar

Who should attend?

  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
  • Validation specialists

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and 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, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

 

. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,