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 111

Validation of Software and Computer Systems in Analytical Laboratories

FDA Requirements and Strategies for Implementation

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. And automated systems are more and more networked so the question is how to validate networks. Last but not least programs are readily available for customization such as Macro programs and spreadsheet applications, they need to be validated, too. On the other hand using risk based approaches can reduce the validation burden for standard functions, but such procedures need to be justified and documented. The question is how much validation is enough?

Key Questions for Software and Computers in Laboratories are:

• How to define a validation program for laboratory computers?
• What and how much to test?
• Are vendor audits required?
• How to define risk categories?
• Should we test standard functions of data systems?
• How to validate Excel applications?
• Haw to validate laboratory networks?
• How to validate existing systems?
• What to revalidate and document after changes?
• How to document system security and data integrity?
• How to validate laboratory computers for part 11 compliance?
• How does the this audio seminar help:

How does the 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 computers.
• How to develop a validation master plan for laboratory computers?
• How to write a user requirement specification document?
• Validation steps: DQ/IQ/OQ/PQ
• Recommendations for risk based validation.
• How to ensure and validate spreadsheet integrity.
• How to ensure system security and data integrity.
• Qualification of laboratory network infrastructure.
• Validation of networked systems.
• 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
  - Validation of spreadsheets and other computer applications,
  - Risk Assessment for Laboratory Systems
  - Change control of software and computer systems
  - Risk based validation of computer systems
• Gap analysis: Laboratory computers systems
• 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 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 worldwide director for FDA compliance at Agilent Technologies and author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years.

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.

He 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.