V&V ONLINE Course
Apr 1, 2024
By Ossie Milanov, B.A.
Cycle 2.0
Quality
Engineering & Validation
Starts at: 09:30
Duration: 4 Meetings
Language: Hebrew and English
This course is designed to give you the tools to make an informed decision regarding the testing and the ability to explain this decision in a manner acceptable to the regulatory authorities.
▪ Review the issue of product verification and validation, from defining the issues to building a protocol, executing and writing a report.
▪ How to read right V&V standards and to create V&V protocols that are applicable to specific devices, by understanding the standards terminology.
WHEN?
3.4.24
10.4.24
WHERE?
Online
Price - 3,000 NIS + VAT
About Ossie Milanov, B.A.
Ossie Milanov is a regulatory and quality expert. She has worked with many start up medical device companies over the years. She has experience in establishing, implementing and maintaining a QMS; in particular effective and compliant Risk Management and Post Market Surveillance. Ossie has experience in preparing Regulatory Strategies and submissions for the FDA, EU and WHO. She has successfully participated in...
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Comments
This course is designed to give you the tools to making an informed decision regarding the testing and the ability to explain this decision in a manner acceptable to the regulatory authorities.
▪ Review the issue of product verification and validation, from defining the issues to building a protocol, executing and writing a report.
▪ How to read right V&V standards and to create V&V protocols that are applicable to specific device, by understanding the standards terminology.
▪ What you need to consider when designing a sterile device including a review on the different types of sterilization, packaging requirement for sterilization and the pros and cons of all the options.
▪ We will discuss about how do you define clean and disinfected? How do you validate a process that you do not control? A brief overview of the different processing methods used throughout the world.
▪ Determining what your packaging validation requirements are. How to build the protocol. What has to be addressed in a packaging validation.