Cleaning Validations Using Extraction Techniques - By Compliance Global Inc.

Cleaning Validations Using Extraction Techniques - By Compliance Global Inc.

 

  • Cleaning Validations Using Extraction Techniques

    Live Session for one participant

    Sale Date Ended

    USD 155
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About The Event

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

For more detail please click on this below link

https://complianceglobal.us/product/700199

Email: referrals@complianceglobal.us
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Tel: +1-516-900-5515