This webinar will provide valuable guidance to medical device manufacturers on how to establish and justify limit values for cleanliness. There are several techniques that may be used to set these limits, including comparison involving statistics and historical data. Justification techniques include biocompatibility and risk assessment. Regardless of what technique is used, regulatory agencies expect that limit values will be set for residual analysis.
The FDA and other regulatory agency do not intend to set acceptance specifications or methods for determining whether a cleaning process in validated. They expect medical device manufacturers to establish and justify cleanliness specification for their devices. Although some documents are in the pipeline, there is no approved standard that provides guidance on how to set and justify limit values for residual analysis.
Areas Covered in the Session :
- Expectations of regulatory agencies on cleanliness specifications
- How to Express Residue Limit Values
- Statistical Comparison
- Baseline Comparison
- Risk-based Assessment
- When and how to adjust limit values
Who Should Attend:
- QA/QC Managers and Personnel
- Validation Managers and Personnel
- Operations and Manufacturing
- R&D and Engineering
- R&D Management
- Engineering Management
- Production Management
- Production Engineers
Course Director: KIERSTAN ANDRASCIK
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.