Process Validation for Medical Device Compliance
Duration: 60 Minutes
The FDA finds inadequacies in process validation for Medical Device firms at an alarming frequency. In fact, the fourth most frequently-cited Form 483 observation for medical device firms is for Process Validation. Find out how you can avoid these observations, and emerge from your FDA audit with zero observations! Medical device validation can be confusing, but this webinar will clear many of the misconceptions related to process validation for medical device companies, and help you to bring your validation program to ship-shape!
Objectives of the Presentation
Why Should you Attend
- The attendee will receive an overview of validation, the key elements (DQ/URS, IQ/OQ/PQ and PV) and understand how these validation elements relate to one another
- The attendee will relate the requirements of process validation back to specified parts of Code of Federal Regulations to assure compliance with the law
- The attendee will learn the Medical Device Validation Guidance Requirements and the apparent discrepancy with pharmaceutical validation
- The attendee will be able to distinguish Validation from Verification
- The attendee will understand key differences between the major elements of medical device validation and pharmaceutical validation practices
- The attendee will learn how to maintain a continual validation state for devices and compare/contrast continual validation with the pharmaceutical notion of continuous process verification
- The attendee will understand other validation elements that support Process Validation to contribute to an overall comprehensive medical device validation program
The requirements for process validation for medical devices can be confusing, because, the correspondence between medical device validation and pharmaceutical validation actions seem to contradict one another. This webinar will point on the similarities and differences to put your process validation in order, so you can pass a validation audit for a medical device manufacturing facility.
Who will Benefit
- Process Validation
- Characterization vs. Engineering Studies vs. OQ
- Difference between GHTF guidance and ASTM E2500 approaches to process validation
- The importance of sound statistical techniques
- Leveraging pharmaceutical guidance to demonstrate that your process maintains a validated state
- Other validation topics
- R&D personnel
- Quality Assurance personnel (Technicians, Managers, Directors)
This training focuses on the requirements of 21 CFR 820 with regard to Process Validation and discusses the Global Harmonization Task Force validation guidance and compares it to validation methodologies commonly practiced in the pharmaceutical industry.