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 搂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鈥檚 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
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 搂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鈥檚 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
