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 141

Validation of Automated Laboratory Systems

What to Implement - The USP <1058> Chapter or the GAMP Good Practices Guide?

Recorded

Laboratory systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on product quality. Validation can be a challenge because laboratory computers become more and more automated. In the past there was no specific guidance from the industry or FDA on how to validate automated laboratory systems. This has changed, now there are two: The new USP draft Chapter <1058> on "Analytical Instrument Qualification" has a chapter on computerized system and the new GAMP/ISPE Good Practice Guide "Validation of Laboratory Computerized System" is entirely focused on automated systems. Both USP and GAMP/ISPE are important FDA references but unfortunately the concepts are different. So the question is: what to implement? .

Key Questions related to automated laboratory systems are:

• What are FDA and international requirements for automated laboratory systems?
• What are the approaches of the USP and GAMP for automated laboratories?
• What are similarities and what are differences?
• Which one should we follow: the USP 4Q life-cycle model of the GAMP combined system integration/system development model?
• Is there a practical model, that can accommodate both?
• What are the industry recommendations and practices for new and existing systems?
• What are the recommendations for commercial systems?
• What do the guides say about risk based testing?
• What exactly are the defined system categories and what should we test and document for each category?

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 give practical recommendations on how to effectively comply with both. 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 automated laboratory systems - What do inspectors ask and what documents should be available.
• Most frequently cited deviations related to laboratory computers.
• The role of GAMP and USP for the FDA and international agencies
• Introducing the GAMP Good Practices Guide
• Introducing the USP draft chapter
• Similarities and differences
• Presenting a model that accommodates both
• Savings through risk based testing
• Case studies: recommendations for 5 systems in different categories
  - life cycle deliverables
  - vendor assessment
  - testing before and during operation
  - documentation

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

• SOPs:
  - Validation of Laboratory Computer Systems
  - Qualification of Equipment,
  - Risk Based Validation of Laboratory Systems
• Gap analysis/work sheets
  - Laboratory computers systems
  - Laboratory audits
• Templates/Examples
  - Requirement Specification for Chromatographic Data Systems
  - Computer System Identification
  - Traceability matrix
  - Test protocol: Authorized system access
• FDA 483 inspectional observations and warning letters with deviations related to laboratory computers
• FDA regulations and guidelines related to computers and equipment
• And more....

Who should attend?

• Analysts and lab managers
• Validation specialists
• 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.