Validation, Regulation, Classification, …
Information and training presentation.… manufacturing validation, validation in design and development, validation life cycle, validation quality assurance, medical device software, good manufacturing practice, risk driven validation, device classification, FDA CFR & EU Device Directive requirements, …
- Medical Device requirements from product development, through manufacturing and end use.
- Step through at your own pace from the convenience of your desktop, laptop, tablet, mobile.
- Use to develop your personal knowledge.
- Use as a support if providing training.
- 780 pages of information, provided in an easy to understand, visual format.
Price $79.Price $59.
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- Introduction to regulatory requirements and international standards.
- How to implement Medical Device Process Validation.
- Software Validation for Medical Device products and processes.
- Implementation of a compliant Medical Device design and development process.
- The Life Cycle Approach to Validation:
- Implementing a Life Cycle Approach. Installation Qualification (I.Q.). Operation Qualification (O.Q.). Pre-Validation Study (PVS). Performance Qualification (P.Q.).
- Implementing an on-going revalidation process.
- How to perform a Validation Gap Analysis.
- How to classify a Medical Device.
- Current Good Manufacturing Practices (cGMP’s):
- Principles of current Good Manufacturing Practice (cGMP). The concept of a device being “fit for intended purpose”. The FDA Quality System Regulations (QSR’s) explained.
- How to identify the need for Validation based on identifying and quantifying Risk.
- Planning, documentation and reporting validation protocols.