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
On-line Audio Seminar 114
Laboratory Equipment Qualification
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
- What exactly are the expectations of inspectors?
- What steps are included in laboratory equipment
- How to develop an equipment qualification master plan?
- What exactly should be in each qualification phase: DQ, IQ,
- 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
- 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
- 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
- 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
- QA managers and personnel
- Regulatory affairs
- Training departments
- Documentation department
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
Qualification in Analytical Laboratories
With Examples from Planning to
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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
||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,