Validation of Computerized Analytical Systems
Instructor:
Dr. Ludwig Huber
Product ID: 700212
Training Level: Advanced
- Duration: 60 Min
Why Should you Attend:
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. This seminar will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.
What Attendees will Learn:
- 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
- Qualification of laboratory network infrastructure
- Validation of networked systems
- How to document planning, specifications, installation, testing and changes
Who Will Benefit:
- Lab Supervisors and Managers
- QA managers and personnel
- Internal auditors
- Analysts
- IT managers and personnel
- Consultants
- Teachers
Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of http://www.labcompliance.com/, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber’s website: http://www.ludwig-huber.com/
More Training By Experts
- Understanding and Implementing USP <1058>: Analytical Instrument Qualification
- Change Control for Computer Systems - strategies and tools for FDA compliance
- Master Planning for Computer System Validation
- Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation
- Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
