Biomedical Technology - Process Validation/Verification
The manufacturing processes used in medical device manufacturing require very careful planning and control to assure bullet-proof performance of the final products. The methods used in this function to comply with FDA and ISO requirements are called process validation and verification, and we can show you how to make these robust and complete for your organization!
Current On-Campus Classes Can Be taught at Your Company!
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Process and Equipment Validation for the Medical Device Industry
This intensive course covers the key aspects of an absolutely essential part of medical device manufacturing…the validation of processes and equipment. Understanding of the key terms and steps in process validation and verification, including qualification steps (IQ, PQ, OQ, etc.), protocol definitions, GHTF guidelines, and selected tools and technique are all covered in this course.
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Customized Classes (call for more information)
- Principles of cGMP for Biomedical Operations
- Essentials of Risk Management
- Fundamentals of Internal/ISO & FDA Preparation
- Process Validation
- Working in a Regulated Environment
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