Overview:
Various regulations for Medical Devices as well as Combination Products require aspects of design control to include these steps. Verification generally addresses whether the device meets its design -basically an internal review whereas Validation evaluates how well the entire system perform when subjected to real-world conditions such as in an operating room -does it work as intended?
There are many details that must be thought-out and addressed for verification steps as well as for validations. There are specific requirements to identify statistical requirements as well as how the device will be tested and addresses what constitutes a satisfactory protocol and a report that can withstand scrutiny.
Why should you Attend: The better the attendee understands what needs to be done and why to do it (What's in it for me?) The webinar answers many practical questions such as how-to do it etc. If the company knows what needs to be done -demonstrates competence, then the process becomes easier -weather it is to obtain regulatory approvals, or pass inspection as much of the discussion in the webinar addresses inspections.
Areas Covered in the Session:
How to figure out statistical requirement for Verification and Validation. Background preparation for V & V including statistical requirement and confirming that the process is stable
What tests to conduct? Prepare and approve test protocol and agree on acceptance criteria
Test Methods Validations -are the tests appropriate, technician trained
List steps for Verification
How to identify what the "system" will do -capability of the product, define user needs and defined operating conditions
Identify key process parameters, conduct DOE
Has the risks been identified and evaluated by comparing risk vs. benefit
Define Operating ranges of process parameters for validation. Prepare SOP's and train operators. Make sure that the instruments are in calibration
Prepare test results forms. Train operators to conduct process validations
Perform statistical analysis and conclusions
Reports approval and project closure -archive reports
Various regulations for Medical Devices as well as Combination Products require aspects of design control to include these steps. Verification generally addresses whether the device meets its design -basically an internal review whereas Validation evaluates how well the entire system perform when subjected to real-world conditions such as in an operating room -does it work as intended?
There are many details that must be thought-out and addressed for verification steps as well as for validations. There are specific requirements to identify statistical requirements as well as how the device will be tested and addresses what constitutes a satisfactory protocol and a report that can withstand scrutiny.
Why should you Attend: The better the attendee understands what needs to be done and why to do it (What's in it for me?) The webinar answers many practical questions such as how-to do it etc. If the company knows what needs to be done -demonstrates competence, then the process becomes easier -weather it is to obtain regulatory approvals, or pass inspection as much of the discussion in the webinar addresses inspections.
Areas Covered in the Session:
How to figure out statistical requirement for Verification and Validation. Background preparation for V & V including statistical requirement and confirming that the process is stable
What tests to conduct? Prepare and approve test protocol and agree on acceptance criteria
Test Methods Validations -are the tests appropriate, technician trained
List steps for Verification
How to identify what the "system" will do -capability of the product, define user needs and defined operating conditions
Identify key process parameters, conduct DOE
Has the risks been identified and evaluated by comparing risk vs. benefit
Define Operating ranges of process parameters for validation. Prepare SOP's and train operators. Make sure that the instruments are in calibration
Prepare test results forms. Train operators to conduct process validations
Perform statistical analysis and conclusions
Reports approval and project closure -archive reports
Speakers
Jack Dhuwalia,
Who Should Attend
- RA
- R&D
- Engineering
- Operations
- Marketing
- QA/Quality Systems Managers
- Senior Managers in Combination Products, Devices and Biologics
