2015 - Cleaning Validations Using Extraction Techniques

Description :
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm to the patient. Regulatory agencies have become increasingly aware of the potential dangers of residual manufacturing materials on medical devices. Therefore, cleanliness has become a hot topic in the medical device community. A thorough validation of the cleaning processes used to remove residual materials from newly manufactured medical devices is necessary to ensure patient safety. One of the most common methods is using extraction techniques to validate the cleanliness of a device.
This 60 minutes webinar will provide in-depth and valuable guidance on how to achieve a thorough validation of a cleaning process.
Areas Covered in the Session :
Cleaning Validation Overview
Defining the Scope
Identifying the Contaminants
Choosing the Test Method
Choosing the Solvents
Setting Extraction Parameters
Validating the Extraction
Setting Limits
Who Will Benefit:
QA/QC managers and personnel
Validation managers and personnel
Manufacturers of Implantable Medical Devices
Manufacturers of Single-Use Medical Devices
Manufacturers of Reprocessed/Reusable Medical Devices