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 163

Analytical Instrument Qualification (AIQ) According to USP Chapter <1058>

Introduction, Update and Strategies for Implementation

Recorded

Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument 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 or requalify, test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This is changing. The USP has developed a draft for analytical instrument qualification (AIQ). It is well known that FDA inspectors require USP standards or equivalent procedures to follow. Therefore pharmaceutical companies are advised to prepare themselves before the standard will become effective. When implemented right the standard also helps to reduce overall qualification costs. Therefore there is lots of interest in learning about the new standard

Key Questions related to analytical instrument qualification are:

• What do FDA and other regulations say about equipment qualification?
• What exactly are the expectations of inspectors?
• What qualification model does the USP standard follow?
• What steps are included in analytical instrument qualification?
• We already have procedures for equipment qualification, 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 embedded 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?
• How should I document instrument 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. 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 analytical instrument requirements
• Most common inspection problems
• Terminology, scope and principles of the new standard
• AIQ and its relation to method validation, system suitability testing and quality control checks
• Essential steps for AIQ: DQ, IQ, OQ, PQ
• Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• Recommendations for firmware and software validation
• Roles and responsibilities: QA, manufacturer, user
• 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
• Recommendations for effective implementation

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

• Nine example SOPs:
  - User Requirement Specifications (URS) for analytical equipment
  - Generation and maintenance of SOPs for laboratory equipment
  - Change control for analytical equipment
  - Qualification of equipment
  - Risk assessment for laboratory systems
  - Qualification of analytical balances
  - Qualification of refrigerators
  - Development and maintenance of test scripts for analytical systems
  - Validation of laboratory computer systems
• Templates/examples:
  - Equipment hardware identification
• Laboratory audit checklist
• 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

Who should attend?

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

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.