Cost Effective Validation of Laboratory Computer Systems

Sept. 15, 2012 - PRLog -- Why to attend:
   
Laboratory computer systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on the quality of API and drug product. Validation can be a challenge because laboratory computers become more and more automated and complex resulting in more demand for validation. Therefore users of laboratory systems are looking for cost-effective validation solutions with examples for all validation steps. During the seminar, the speaker will present cost-effective validation 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.

Areas Covered in the Seminar:

* FDA GxP, Part 11 and EU Annex 11  requirements
* What do inspectors ask and what documents should be available.
* Most frequently cited deviations related to lab computers
* Laboratory system validation according to GAMP® and USP
* Developng a validation master plan for laboratory computers
* Writing user requirement specifications
* Validation steps with examples: DQ/IQ/OQ/PQ
* Recommendations for risk based validation.
* Validation of networked systems
* Validation of existing systems
* Maintaining laboratory systems in the validated state
* Validation of integrated instrument hardware and computers
* Documenting validation steps from planning to reporting

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

* SOP: Validation of Laboratory Computer Systems
* Risk Assessment for Laboratory Systems
* Risk based validation of laboratory computers
* Gap analysis: Laboratory computers systems
* Templates/Examples for Chromatographic Data Systems
- Project plan
- Requirement Specifications
- Vendor qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Test plan
- Test protocols

Date:  October 25, 2012
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Who should attend
* Analysts and lab managers
* Validation specialists
* QA managers and personnel
* IT Managers and staff
* Regulatory affairs
* Training department
* Documentation department
* Consultants

Weblink:  http://www.labcompliance.com/seminars/audio/300/default.aspx

Category: Pharmaceutical, API Manufactuer, FDA, Training, Validation, Laboratories, Computers

Presenter: Dr. Ludwig Huber

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of Labcompliance, the global on-line resource for validation and laboratory compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. He has been selected as IVT's "Presenter of Year" out of 175 presenters. He is also the author more than 100 papers including the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories,”. Currently, Dr. Huber is on the Scientific Advisory board of IVT’s GxP and Validation Journals, and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the  US FDA, ISPE, PDA, PIC/S and several national health agencies including China SFDA