Topic: Risk Based Process Validation for Medical Devices
Note: Thursday 5:45pm to 7:30pm US-MT meeting
RSVP on Boulder Section’s meeting "Meetup Link"
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5:45 pm Web Conference Start: Networking, Welcome and Section Business
6:00 pm Presentation
- Learn how a Risk Based Process Validation approach using Failure Modes & Effects Analysis can be used to meet FDA ,1SO 14971 Medical Devices directive, and Global Regulatory Requirements
- Risk Management overview and concepts.
- Review process verification & validation definitions, concepts, and application
- Process validation using risk-based approach provides a higher degree of confidence & reliability in process outputs
- Bio: Steven Reischel
- ASQ-Certified Quality Engineer, proven detailed oriented, independent decision maker and critical thinker.
- Excellent multitasking skills, technical writing, teams and time management abilities.
- Accountable, task oriented and highly energetic while working collaboratively with cross functional teams and stakeholders.
- 25 years of Manufacturing industry (ISO 9001/13485/AS9001) experience
- Including Medical Device Class III & II and Aerospace/Defense experience
- Past ASQ Boulder Section chairperson
7:15 pm After Presentation Networking
7:30 pm Web Conference End: meeting over
Place: Web Conference Webex
Meeting also posted on ASQ Boulder Meetup's 23 Mar 2023 meeting