Compliance Trainings, Online
2015-04-23
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 validations Understanding IQ, OQ, PQ, & PPQ Scripting the validation protocol Selecting confidence intervals Training requirements Equipment calibration requirements Use of 3rd-party testing facilities to execute validations Collection of validation data The application of statistical analysis and documenting statistical rationale Limit versus Challenge Conditions Documenting deviations Addressing validation failures Documenting the requirement(s) for when to repeat validation Who 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 Professionals Regulatory Professionals Test Technicians R & D Engineers Manufacturing Engineers Quality Engineers Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : #416-915-4458 Email : support@compliancetrainings.com
|