Webinar On Cleaning Validations Using Extraction Techniques

Compliance Trainings, Canada
2015-04-20

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

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

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

Kierstan Andrascik, founder of QVET Consulting, with her years of experience in the medical device industry assists manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness. She also provides guidance in many other areas including sterilization, biocompatibility, packaging, and materials characterization. Previously, she worked at Nelson Laboratories in Salt Lake City, Utah where she served as study director covering a variety of testing including new device cleaning validations, materials characterization, and package testing.

In 2002, she began developing a method to quantify residual manufacturing materials on medical devices. In 2005, ASTM published a similar method as F2459. Kierstan has been actively serving on the ASTM Device Cleanliness subcommittee since 2005. She received a Certificate of Achievement from ASTM in May 2007. In the June 2008 issue of Medical Design magazine, her article titled "How to tell if a device is really clean" was published. Then, in April 2011, her chapter “Cleaning Validations using Extraction Techniques” published in the 2nd edition of Handbook for Critical Cleaning. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1145