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 226

Calibration and Qualification in Analytical Laboratories

With Examples from Planning to Reporting

Recorded

Laboratory equipment should be calibrated and/or 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 have a high impact on product quality. Despite the fact that equipment calibration and 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 calibration and qualification?
• What exactly are the expectations of inspectors?
• What is the difference between calibration and qualification?
• How does USP chapter <1058> fit into calibration
• What steps are included in laboratory equipment calibration and qualification?
• Is there a list of instruments with USP categories?
• How to develop an equipment qualification master plan?
• What exactly should be done 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?
• How can existing equipment be qualified/calibrated?

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:

• Operational lab equipment requirements for calibration and qualification
• Most common inspection problems
• USP Chapter <1058>: Analytical Instrument Qualification
• Development of an effective equipment qualification master plan
• Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
• Allocating equipment to qualification categories A, B and C
• Qualification and documentation requirements for each category
• Going through the category example list
• Approach for existing systems
• Approach for automated systems (incl. firmware/computer systems)
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
• Documentation requirements

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

• Equipment Validation Master Plan
• 6 example SOPs:
  - User Requirement Specifications (URS) for analytical equipment
  - Change control for analytical equipment
  - Qualification of equipment
  - Qualification of refrigerators
  - Development and Maintenance of Test Scripts for Analytical Systems
  - Allocating Analytical Instruments to USP <1058> Categories
•  8 templates/examples - HPLC System
  - Validation plan
  - Requirement Specifications
  - Vendor assessment
  - Design Qualification
  - Installation Qualification
  - Operational Qualification
  - Performance Qualification
  - Summary report
• Suggestions for USP Analytical Instrument Categories
• 20+ Examples for Instrument OQ Testing
• Equipment Master List with USP Categories
• Reference Articles
  - Selecting Parameters and Limits for Equipment Operational Qualification
  - Operational Qualification in Practice
• Warning letters and Inspectional observations related to laboratory equipment qualification.
• FDA Publication: Overview of Equipment Qualification

Who should attend?

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

Date, time and duration

September 17, 2009
North America: ET 11 a.m.  CT 10 a.m. PT 8 a.m., Europe: CET 5 p.m (Paris/Berlin)
Check: www.timeanddate.com/worldclock/ for you local time.
The seminar will last one hour

Date, time and duration

Order at any time, replay at any time.

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.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
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.-

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.