Cleaning Validations Using Extraction Techniques

Cleaning validations are an essential step in the medical device development process. 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 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.

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

Speaker Profile

Kierstan Andrascik has worked in the medical device industry for more than 12 years. She founded QVET Consulting in 2009 to assist medical device 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.

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Technical Writing for the Pharma, Device and Biotech Industries

Technical Writing for the Pharma, Device and Biotech Industries 3

Technical writing for the IT industry is quite different from technical writing for the pharma, device and biotech industries. Technical writing for the pharma, device and biotech industries is a combination of skills and science. On the one hand, it requires extensive knowledge required from these vast and diverse, albeit related industries. On the other, it requires good language skills to present on paper what would otherwise constitute dull and prosaic writing that the common reader would likely find quite obtuse.

Understand the audience

Technical Writing for the Pharma, Device and Biotech Industries

Technical writing for the pharma, device and biotech industries involves first of all, knowing whom the writing is being done for. This is the foremost requirement, because the level of jargon or depth of the subject that goes into technical writing for the pharma, device and biotech industries is directly proportionate to the level of knowledge the audience has of the subject. If the audience is a professional or academic with high credentials, it is necessary to shape the writing to suit them. Likewise, it is advisable to remain simple and effective and rid the writing of its high sounding cant if it is for a lesser audience.

Understand the minds of regulatory bodies

Technical training in the life sciences

A professional doing technical writing for the pharma, device and biotech industries needs to have a grasp of the intricacies that documentation for regulatory bodies expect and require. The FDA, Eudralex, the ISO and other such bodies require their own standards, so it is necessary for those doing technical writing for the pharma, device and biotech industries to be aware of these.

Understand for whom the writing is being done

Technical training in the life sciences1

Anyone doing technical writing for the pharma, device and biotech industries has to be aware of the market for which the writing is being done. They should understand the role and importance their writing plays with the eventual user. There should be clear understanding of whether technical writing done for the pharma, device and biotech industries is going to be used for higher research, for understanding the market better, or for understanding the competitor, and so on.

Understand the nitty gritty of the industryAlso, when doing technical writing for the pharma, device and biotech industries; the writer has to have a good grasp of the technicalities of the industries. Terms in these industries are filled with many hairsplitting definitions and specifications. The writer doing technical writing for the pharma, device and biotech industries has to be completely aware of the differences between each of these. It is only when these fundamentals among others are grasped that writing becomes successful and effective. The ability to also revise and edit what is written should be built into technical writing skills for the pharma, device and biotech industries.

 

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