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Webinar On A Robust Approach to Validation in Compliance with 21 CFR, Part 820.

Failure to validate processes in accordance with §820.75 requirements

Description :Regardless or regulatory environment, United States or OUS, the validation of processes, which cannot be verified through inspection or test, is considered a salient requirement for medical device establishments. It is imperative that processes are capable of producing finished medical devices that are safe and effective in their intended use.Failure to validate processes in accordance with §820.75 requirements is a frequently cited Form 483 observation in FDA warning letters. Device establishments either fail to validate their processes; or fail to validate their processes, with a high degree of assurance in accordance with established procedures. Remember, a manufacturing process that cannot be fully verified by subsequent inspection and testing is expected to be validated, to ensure the process continues to meet specifications as required by 21 CFR 820.75(a).Areas Covered in the Session :FDA requirements for validationsUnderstanding IQ, OQ, PQ, & PPQScripting the validation protocolSelecting confidence intervalsTraining requirementsEquipment calibration requirementsUse of 3rd-party testing facilities to execute validationsCollection of validation dataThe application of statistical analysis and documenting statistical rationaleLimit versus Challenge ConditionsDocumenting deviationsAddressing validation failuresDocumenting the requirement(s) for when to repeat validationWho Will Benefit:A must attend webinar for all industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with your organization’s validation studies. The staff who will benefit include:Quality ProfessionalsRegulatory ProfessionalsTest TechniciansR & D EngineersManufacturing EngineersQuality EngineersPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 


23 Apr 2015 @ 01:00 pm

23 Apr 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar



Organised by

FutureCorp Consulting (deactivated)

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