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 155

Equipment Qualification

Introduction, Requirements and Strategies for Implementation

Recorded

Equipment used in regulated laboratory and manufacturing environments should be qualified to demonstrate suitability for the intended use. 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 equipment qualification?
• What is the difference between commissioning and 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:

During the seminar, the speaker will give an introduction on equipment qualification, present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, checklists, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA and EU 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
• Examples from manufacturing and laboratories

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

• CASE STUDY: Complete templates and/or examples for equipment qualification: Qualification Plan, Requirement Specifications, Vendor Assessment Statement, Risk Assessment, Test Plan, Operational Qualification, Performance Qualification, Summary Report
• Master plan: Equipment Validation
• SOP: Equipment Qualification
• SOP: Qualification of Refrigerators
• SOP: Calibration of Analytical Balances
• SOP: Change Control for Equipment
• SOP: Maintenance of Equipment
• SOP: Development of User Requirement Specifications for Equipment
• SOP: Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems
• SOP: Installation Qualification for Manufacturing Equipment
• SOP: Operational Qualification for Manufacturing Equipment
• Example Protocol: Performance Qualification HVAC System – White Product Lines
• Reference paper: Equipment Qualification in Practice
• Reference paper: Selecting Parameters and Limits for Operational Qualification
• FDA Inspection reports: EIR, 483s, Warning Letters related to EQ
• And more...

Who should attend?

• Lab Supervisors and Managers
• QCU Managers
• "Qualified Persons" as required by EU GMP
• QA managers and personnel
• GLP/GMP auditors
• Metrology groups
• IT managers and personnel
• Consultants
• Teachers

How to order

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

Recorded seminar - Web download 'Site' offer 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$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

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 author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.