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Recorded Webinar
Quality systems for Analytical Instrumentation and how it relates to FDA, COLA, EU guidelines
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
FDA, COLA and EU regulations require that manufacturers developing instrumentation for use in their industry have a program for the controlled, regulated development and production of test and measurement equipment. The Certification Body (UA, CSA, TUV) must include: An approved Quality System, scheduling, specific procedures, checks and balances for controlling the output of quality regulated instrumentation, and the ability to service and support these products in the field to factory standards using the concept of configuration control.
This webinar will discuss Quality System development in the instrumentation sector and how this applies to FDA, COLA and EU directives.
Areas Covered in the Webinar:
- Importance of Instrumentation developed in a controlled Quality System for use in an FDA, COLA, EU environment.
- Pros and Cons of using ISO 9001 developed instruments.
- Does it matter if the product is ISO certified or not.
- The quality system in a scientific equipment manufacturer.
- Understanding Mean Time Between Failure (MTBF) information
- How configuration control relates to Installation and Operational Qualifications, also Instrument
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