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

• Speaker: Risk Based Process Validation for Medical Devices
• Topic: Risk Based Process Validation for Medical Devices
• Presentation Slides and Video posted after meeting
• 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: ucKKvh6mP62

Meeting also posted on MyASQ Boulder Community Event