ASQ Boulder 2023-Mar-23 Section Web Meeting

When:  Mar 23, 2023 from 05:45 PM to 07:30 PM (MT)
Associated with  Boulder Section

Topic: Risk Based Process Validation for Medical Devices
Cost: Free
Note: Thursday 5:45pm to 7:30pm US-MT meeting

RSVP on Boulder Section’s meeting "Meetup Link"

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RSVP note: Please provide your Name and Hometown. Same for any guests
5:45 pm Web Conference Start: Networking, Welcome and Section Business
6:00 pm Presentation

  • Abstract:
    • 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
  • References:
    • None Yet

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


Online Instructions:
Login: - Meeting number: 2554 691 5231 - Password: ucKKvh6mP62


Arnold Miller
+1 303-868-4807