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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.

On-line Audio Seminar 114

Laboratory Equipment Qualification

Recorded

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Laboratory equipment should be qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on product quality. Despite the fact that equipment qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.

Key Questions related to laboratory equipment qualification are:

  • What do FDA and other regulations say about equipment qualification?
  • What exactly are the expectations of inspectors?
  • What steps are included in laboratory equipment qualification?
  • How to develop an equipment qualification master plan?
  • What exactly should be in each qualification phase: DQ, IQ, OQ, PQ
  • What and how much should be tested?
  • What to test after changes, e.g., when the equipment is moved, repaired or updated?
  • There is lot's of talking about risk based validation and qualification. How can my qualification work benefit from this?
  • How can existing equipment be qualified?
  • How should I document equipment qualification?

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.

During the interactive presentation you learn about:

  • FDA and EU lab equipment requirements
  • Most common inspection problems
  • Development of an effective equipment qualification master plan
  • Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • What and how much testing should be done and documented
  • Approach for existing systems
  • Approach for automated systems (incl. firmware/computer systems)
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • What documents should be available for the FDA

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

  • 10 example SOPs:
    - Laboratory failure investigations
    - User Requirement Specifications (URS) for analytical equipment
    - Generation and maintenance of SOPs for laboratories
    - Change control for analytical equipment
    - Qualification of equipment
    - Maintenance of Equipment
    - Risk assessment for laboratory systems
    - Qualification of analytical balances
    - Qualification of refrigerators
    - Development and Maintenance of Test Scripts for Analytical Systems
  • Templates/examples - HPLC System
    - Validation plan
    - Requirement Specifications
    - Design Qualification
    - Installation Qualification
    - Operational Qualification
    - Performance Qualification
  •  Equipment hardware identification
  • Laboratory audit checklist
  • Warning letters and Inspectional observations related to laboratory equipment qualification.
  • Publication: Overview of Equipment Qualification

Who should attend?

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

How to order

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

Replaced by the more recent seminar

Calibration and Qualification in Analytical Laboratories

With Examples from Planning to Reporting

Click here

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.