Medical Device Process Validation…

If involved in the design and manufacture of medical device products, you will need to fully understand the various medical device regulatory requirements and international standards, e.g. FDA Process Validation requirements, ISO 13485, ISO 14971, etc.. To permit the sale of medical products throughout the European market you will need to understand the medical device regulations such as MDD 93/42/EEC and it’s more recent updates.

The following are details of the training presentation on medical device regulations, the FDA validation requirements, etc., from design through to manufacturing release.

Medical Device, design, product and process validation.

Medical Device, design, product and process validation.



Over 700 pages of information. Inform yourself. Refresh your understanding.
 

♦ Introduction to the US FDA and EU Medical Device regulatory requirements
♦ Overview of the key International standards relevant to Medical Devices
♦ How to the classify Medical Devices
♦ Review of current Good Manufacturing Practices (cGMP’s)
♦ What are the key components of an effective Quality Management System
♦ 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 an on-going revalidation process
♦ Creating a comprehensive Validation Master Plan (VMP)
♦ How to perform a Validation Gap Analysis
♦ How to identify the need for Validation based on identifying and quantifying Risk
♦ Planning, documentation and reporting validation protocols
♦ How to perform effective auditing to ensure Validation compliance

 
MedicalDeviceValidation-small_03
Full details of the information and training presentation on Medical Device Validation.
 

Much more than just “VALIDATION”…..
If you are involved in the design, manufacture, release to market of medical devices, you need to have a broad knowledge across a range of regulatory compliance, product and process improvement, quality management, risk management and validation methodologies. Organizations need to ensure staff are fully trained and competent, in order to comply with regulatory body expectations and are confident that employees can effect continuous product and process improvement while maintaining necessary compliance.

What are the regulatory requirements for compliant validation? How are medical devices classified? How do you integrate risk into the validation process? How do you perform a validation gap analysis? How is validation effectively performed during product design? How is medical device software validated? Etc., etc..

For effective and compliant validation, you need to understand …
Life Cycle Approach to Validation.
Product and Process Design Validation
Quality Assurance requirements related to Validation compliance.
Risk driven Validation
Current Good Manufacturing Practices
Software Validation practices
Medical device classification
Re-Validation processes
Validation Master Plan
Validation Gap Analysis
Protocol Reporting

Medical Device Software Validation >>>
Medical Device Manufacturing Validation >>>
FDA Validation requirements for Medical Devices >>>
Preparing for an FDA GMP Audit >>>
Equipment Validation >>>
Medical Device Risk Management >>>
Validation Gap Analysis >>>
Life Cycle approach to Process Validation >>>
Australian regulatory requirements for Medical Devices >>>
FDA 21 CFR part 11 compliance >>>
Classification of Medical Devices under the EU Directives >>> 
 
MedicalDeviceValidation-small_03
Full details of the information and training presentation on Medical Device Validation.