Cleaning Validations Using Extraction Techniques
| Date: | 01-Dec-15 to 01-Dec-15 |
| Location: | Online Event / United States |
| Category: | Education Conferences & Trade Fairs |
Overview
Cleaning validation guidelines are an essential step in the medical device development. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process.
Why Should You Attend
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm for healthcare services. Regulatory agencies have become increasingly aware of the potential dangers of residual materials on medical devices. Therefore, cleanliness has become a hot topic in the medical device community.
The March 2015 publication of the FDA Guidance for “Reprocessing Medical Devices in Health Care Settings” has made the FDA validation stance very clear: cleaning processes must be validated. A thorough validation of the cleaning processes used to remove residual materials from both newly manufactured and reprocessed medical devices is necessary to ensure patient safety.
Areas Covered in this Webinar
Cleaning Validation Overview
Defining the Scope
Identifying the Contaminants
Choosing the Test Method
Choosing the Solvents
Setting Extraction Parameters
Validating the Extraction
Setting Limits
Learning Objectives
How to validate a cleaning process
What testing is appropriate for a cleaning validation
How to validate the extraction technique
Who Will Benefit
QA/QC Managers
QA/QC Personnel
Validation Managers
Validation Personnel
Medical Device Manufactures
Level
Beginner
Cleaning validation guidelines are an essential step in the medical device development. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process.
Why Should You Attend
Medical device manufacturers have always been under scrutiny to ensure that their product does no harm for healthcare services. Regulatory agencies have become increasingly aware of the potential dangers of residual materials on medical devices. Therefore, cleanliness has become a hot topic in the medical device community.
The March 2015 publication of the FDA Guidance for “Reprocessing Medical Devices in Health Care Settings” has made the FDA validation stance very clear: cleaning processes must be validated. A thorough validation of the cleaning processes used to remove residual materials from both newly manufactured and reprocessed medical devices is necessary to ensure patient safety.
Areas Covered in this Webinar
Cleaning Validation Overview
Defining the Scope
Identifying the Contaminants
Choosing the Test Method
Choosing the Solvents
Setting Extraction Parameters
Validating the Extraction
Setting Limits
Learning Objectives
How to validate a cleaning process
What testing is appropriate for a cleaning validation
How to validate the extraction technique
Who Will Benefit
QA/QC Managers
QA/QC Personnel
Validation Managers
Validation Personnel
Medical Device Manufactures
Level
Beginner
Exhibitors
Kierstan Andrascik
EIN News
provides powerful, real-time media monitoring, news aggregation & syndication services. Read the latest news about this topic. See:
