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Validity : 21st Apr'25 to 01st May'25
Validation of Laboratory Instruments and systems
- Requirements of FDA and equivalent International organizations - What do inspectors ask and what documents should be available.
- Most frequently cited deviations related to laboratory equipment and systems.
- Laboratory system validation according to GAMP® Guides and USP Chapter <1058>.
- Developing a validation master plan for laboratory equipment.
- Writing user requirement specifications.
- Going through validation steps with examples for: DQ/IQ/OQ/PQ
- Recommendations for risk based validation.
- Validation of existing systems.
- Maintaining laboratory systems in the validated state.
- Validation of integrated instrument hardware and computer systems.
- Documenting validation steps from planning to reporting with examples.
Overview of the webinar
Laboratory equipment and systems should be validated to demonstrate suitability for the intended use. Laboratory systems including equipment and computer systems are amongst key targets of FDA inspections. They are considered high risk because when used to confirm the quality of product batches they have a high impact on product quality. Despite the fact that the validation of laboratory equipment and the computer system is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to validate, test and document.
Who should attend?
- Quality Assurance / Quality control specialists.
- Laboratory chemists and supervisors
- QA managers and personnel
- Regulatory affairs
- Training department
- Documentation department
Why should you attend?
Validation of laboratory instruments and systems is a complex task. Systems consist of equipment hardware, computer hardware and software and they may also be part of the laboratory network. Despite the fact that high-level requirements for validation are documented in regulations and official guidelines e.g., by US FDA and from the US Pharmacopeia (USP), validation specialists are still unsure on how to comply with the official requirements because of the lack of details.Therefore FDA frequently finds instruments and systems that do not fully comply with requirements and therefore FDA writes deviation reports in form of inspectional observations and warning letters. They can companies cost a lot of money.
This webinar will provide attendees with all details and examples on validation of laboratory instruments and systems from writing a validation plan and requirement specifications (DQ) through installation qualification (IQ ),operational qualification (OQ), and performance qualification (PQ) to writing the validation report.
Faculty - Dr.Ludwig Huber
Dr. Ludwig Huber, Ph.D., is the chief advisor and editor of www.labcompliance.com the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare, and of the 70-page primer: Validation of Analytical Methods".
He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.
Dr. Huber has been awarded as
• The Presenter of the year at IVT conferences, selected by thousands of attendee as #1 out of 175 presenters
• The Winner of the "First International GLP Award" from Indian Drug Manufacturer Association for Publications and Presentations in the Area of GLP and GMP
• Winner of the Wallhaeusser award, sponsored by the European Compliance Academy for publications in the area of 'Quality and Safety of Drugs'