- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
Cleanliness is a hot topic in the medical device industry. The FDA expects medical device companies to validate the cleanliness of their devices. One of the best ways to achieve a clean device is by designing it with cleanliness in mind.
why should you attend
This webinar will provide valuable guidance to medical device manufacturers on design considerations for both single-use and re-usable devices. There are certain design elements that are more difficult to clean and should be avoided whenever possible. With the “right” design, both the manufacturing and cleaning process validation can be simplified.Click to View the Pricing Plan
- Design Requirements Document
- Single-Use Design Considerations
- Re-usable Design Considerations
- Design Elements to Avoid/Minimize
- Simplifying the Manufacturing Process
- Simplifying the Cleaning Process
- Why cleaning must be considered during the design phase
- What design elements should be avoided or minimized
- What can be done to simplify the manufacturing and cleaning processes
WHO WILL BENEFIT
- QA/QC Managers and Personnel
- Validation Managers and Personnel
- R&D Professionals
- Engineering Professionals
- Compliance Officer
- Marketing & Sales
Kierstan Andrascik has worked in the medical device industry for more than 13 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. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.