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 106

Validation of Computerized Laboratory Systems

Implementing the New GAMP Guide for Laboratory Systems

Recorded

The GAMP Guide for Validation of Automated Systems (GAMP 4) is recognized as industry standard for computer validation. While this guide is an excellent framework for computer validation in general it is not detailed enough for specific applications, for example laboratories. On the other hand because of their criticality laboratory computers are right on target of FDA inspections. To close the GAP GAMP has developed a special good practice guide for laboratory computer systems. The guide is expected to be the single most important reference for automated laboratory systems from stand alone automated systems to complex networked systems and the FDA and EU Agencies are using GAMP Guidance as reference. When implemented right the guide also helps to reduce overall validation costs. Therefore there is lots of interest in learning about the new guide and it's seven systemcategories.

Key Questions for Laboratory Computers are:

• What is new in this guide?
• What are the seven system categories?
• What is it we should validate for different categories?
• How to validate small automated systems without computers?
• Where do Excel® spreadsheets fit in?
• When are vendor audits recommended?
• What and how much to test?
• How much to test for 'identical' systems used 'in the same manner'.
• How to define risk categories and what does it really mean?
• What to validate for medium and low risk systems?
• How to document system security and data integrity?

How does the new GAMP guide and this 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 give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA and EU requirements for laboratory computers - What do inspectors ask and what documents should be available.
• Most frequently cited deviations related to laboratory systems.
• Definition of seven GAMP categories.
• Validation and documentation requirements for each category.
• New lifecycle concepts: Software development vs. software implementation
• Savings from risk based validation.
• Case Study: Validation of small automated systems
• Case Study: Validation strategy for chromatographic data systems
• Case Study: Validation of spreadsheets.
• Special focus: Reducing test efforts for 'identical' systems.
• Required procedures for system security, configuration management, back-up, archiving and disaster recovery.
• How to document planning, specifications, installation, testing and changes

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

• SOPs:
  - Validation of Laboratory Computer Systems
  - Risk Assessment for Laboratory Systems
  - Developing and Maintenance of Test Scripts for Analytical Systems
  - Change control of software and computer systems
  - Validation of spreadsheets and other computer applications
• Gap analysis: Laboratory computers systems
• Examples
  - Requirement Specification for Chromatographic Data Systems
  - Template: Computer System Identification
  - Traceability matrix
  - Test protocol: Authorized system access
• FDA 483, establishment inspection reports and several warning letters with deviations related to laboratory computers
• And more....

The new ISPE GAMP Good Practice Guide: Validation of Laboratory Computer Systems is not included in the seminar material. It can be ordered from the ISPE website: www.ispe.org

Who should attend?

• Analysts and lab managers
• Validation specialists
• Metrology groups
• QA managers and personnel
• Regulatory affairs
• Training department
• 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.