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Validation Life Cycle
Product and Process Validation Lifecycle
The validation lifecycle is an approach to product and process validation from concept stage, through to end customer use, with a continuous feedback loop, that confirms continued adherence from the original design specifications through to end customer requirements. Many regulatory organizations now promote the life cycle approach to validation,...
 
Validation Life Cycle
Change Management Process
For details of currently available information and training presentations   >>>

 

Introduction to Change Management: All products and all process will undergo change. The reason for the change may arise due to design change associated with the products, change in raw materials, change in technologies, change in regulatory requirements, change in test methods, change ...
 
Change Management Process
Quality Management System Training Presentation
A comprehensive effective quality system is an essential pre-requisite for success is all organizations. Depending on the business segment and size of the organization in question, the quality system needs to be developed to suit the specific business requirements. Many organizations have perfectly good quality systems but do not have any formal certification stating compliance with spec...
 
Quality Management System Training Presentation
FDA Quality System Regulations: Control of Documentation.
The fundamental concepts of current Good Manufacturing Practices for Medical Devices are:
• Consistency – one can only have confidence in a process if it leads to the right result every time.
• Continual Improvement – what is acceptable today may not necessarily be accepted next year. Thus GMPs evolve over time: hence the word “current”.
 

Note: Good Manufacturing...
 
FDA Quality System Regulations: Control of Documentation.
Validation requirements for Medical Device products.
How Medical Devices are regulated in Australia and the key elements of the regulatory scheme >>>

The Essential Principles for Medical Device Compliance >>>

Life cycle approach to regulation by the Australian TGA >>>

Differences between Australian and EU Medical Device Regulation >>>

Differences between Australian Essential Principles and Eu...
 
Validation requirements for Medical Device products.
Plan Do Check Act approach to improvement. Training presentations.
The objectives of implementing a benchmarking program, for an organization are many and varied, however usually include some or all of the following reasons....

To determine who is the best out there in terms of a specific or range of capabilities. To identify world-class performance levels. To determine the drivers of superior performance within competitor organizations, to quantify ...
 
Plan Do Check Act approach to improvement. Training presentations.

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