Medical Device Manufacturing Validation...Validation of a medical device prior to the device entering the manufacturing process demands an understanding of the applicable regulatory requirements, an evaluation of product and process risks, clear establishment of customer expectations, clarity of business resource capabilities, understanding of quality system requirements, etc., etc.. Applicable standards and regulations will be along the lines of 21 CFR 820, 93/42/EEC, ISO 13485, ISO 14971, 2007/47/EC, which you need to understand and effectively apply.
The first step will be the drafting of the Master Validation Plan, which will answer questions such as:
• How will risk identification input into the validation process?
• How does device classification impact the validation process?
• What are the applicable regulatory requirements?
• How to ensure compliance with good manufacturing practices?
• What are the Medical Device reprocessing regulations?
• How to optimize the use of statistical analysis in the validation process, … etc…
Within the Master Validation Plan, will the approach to process validation be to treat the validation activities as part of a “life cycle activity”. Will “Quality by Design” be the basis for an acceptable validation process? A risk analysis will need to be applied in order to accurately identify CQAs (critical quality attributes) and CPPs (critical performance parameters). Will be approach be “Worst Case Analysis”, i.e. will the focus to be on true performance qualification rather than on “worst case” validation runs. There will need to be a greater focus on monitoring and testing in the early stages of manufacturing, backed-up by an effective quality system for trend analysis and process correction.
Information and training presentation on the regulations and practices for effective and compliant Validation of Medical Devices within a Manufacturing environment >>>
Medical Device Software Validation >>>
Electronic Signature requirements in Medical Device Manufacturing >>>
Conflict in Team >>>
Good Manufacturing Practices for Medical Devices >>>
Classification of Medical Devices under the EU Directives >>>
When to Validate, when to Verify a process >>>
Validation Master Plan >>>
Australian regulatory requirements for Medical Devices >>>
Total Productive Maintenance >>>
Cost of Quality >>>
Process Cycle Time reduction >>>>
How to implement TQM >>>