ASQ Boulder 2023-Mar-23 Section Web Meeting

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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5:45 pm Web Conference Start: Networking, Welcome and Section Business
6:00 pm Presentation

• Speaker: Steven Reischel, ASQ-CQE
• Topic: Risk Based Process Validation for Medical Devices
• Presentation Recording at https://my.asq.org/viewdocument/2023-03meeting-risk-based-video?CommunityKey=f1d26709-601f-4e21-873f-018670cc8948  
  Presentation Slides at https://my.asq.org/viewdocument/2023-03presentation-risk-based-proc?CommunityKey=f1d26709-601f-4e21-873f-018670cc8948  
  

• 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 link: https://asq.webex.com/asq/j.php?MTID=ma9a48415e148fcc1f5a91eb04875c23a
• Meeting number: 2554 691 5231<
• Password: ucKKvh6mP6

Meeting also posted on ASQ Boulder Meetup's 23 Mar 2023 meeting