Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Co Read more
In this webinar, learn about the 2019 approach to compliant design control, how to create, manage, and maintain the information found in the various Risk Management documents and files. Get insights about how to shrink documentation time to provide enough time for actual risk management and mitigation.
Course Objectives:
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.
Course Outline:
• The 2019 approach to design control
• What do FDA and ISO say about it?
• How do you present it to management?
• What are the key steps in risk-based design control?
• How to implement risk-based design control in your company
• Bringing it all together – links to design and process
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control
From Medical device and combination product biotechnology devices
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