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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 379

Understanding the new Revision of USP <1058> 

With SOPs, Templates and Examples for easy Implementation

Recorded, available with all reference material at any time

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USP has released the second in-process revision of Chapter <1058>: Analytical Instrument Qualification. Changes are based on inputs to the first revision, so this 2nd rev is much more close to the final chapter than the first revision. Compared to the current release there are some major changes, for example, the new revision is proposing for AIQ an integrated approach that is based on risk. The chapter explains where the risk assessment begins and how the risk correlates to the complexity of the instruments, There are more new requirements, e.g., periodic review. The industry has some difficulties to implement the new requirements, so there are many questions.

Key Questions related to the new USP <1058> revision

  • What are the changes of the new revision to the existing chapter?
  • When will the new revision be effective?
  • Which section of our 1058 SOP do we need to change and how?
  • The section on equipment  categories disappeared, what to do?
  • When is 1058 mandatory, even so the chapter number is above 1000?
  • How can we apply 1058 to laboratory computer systems?
  • The new revision has more details on the four qualification phases: what exactly should be in each phase: DQ, IQ, OQ, PQ?
  • How to qualify firmware?
  • Does the revision answer the question: What and how much should be tested?
  • What to do for integrated systems comprising equipment and computers?
  • Does the  revision also apply to software frequently used in laboratories, for example, Excel spreadsheets?
  • Who is accountable for the qualification and validation
  • How to implement the new revision most effectively?
  • When is the final version coming and what will there be major 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:

  • Terminology, scope and principles of the new revision .
  • Changes to the existing chapter
  • AIQ and its relation to method validation, system suitability testing and quality control checks
  • Approaches for risk based qualification: where does risk assessment start
  • The 4Q Qualification lifecycle approach: DQ, IQ, OQ, PQ
  • Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • Dealing with three instrument categories A, B and C
  • Recommendations for supplier assessment
  • Requirements for outsourcing AIQ
  • Roles and responsibilities: Quality unit,  manufacturer, user
  • Integrating software validation and equipment qualification
  • Integrating the USP 1058 revision with the GAMP Guide on Laboratory Computerized Systems
  • Dealing with changes of software, firmware and equipment hardware
  • Qualification of existing/legacy systems
  • Recommendations for effective implementation of the new revision
  • Expectations for the final chapter?

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

  • Six examples SOPs
    - Analytical Instrument Qualification for <1058>
    - Allocating Analytical Instruments to USP <1058> categories
    - Procedures and deliverables for USP <1058> categories
    - Change control for analytical equipment
    -
    Maintenance of equipment
    - Development and maintenance of test scripts for analytical systems
  • Examples/templates:
    - Validation plan, URS, DQ
    - Risk assessment
    - 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
  • 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 and time

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,