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3-hr webinar:Design Controls for Medical Devices

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

"Hear By Susanne Manz who holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality."

Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.

Description

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 3-hour webinar will cover the basics of design controls for medical devices.  Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.  This webinar can help you create a design control process that is a competitive strength for your company.

Mistakes made during the design phase can cause customer dissatisfaction, compliance issues, or even harm your customers leading to MDRs and even recalls.  These mistakes are sometimes difficult to correct later in the product lifecycle.  It is important to understand and efficiently/effectively incorporate design control into your product development process.    In this webinar you’ll hear from an industry expert on how to create an effective, compliant design control process.

Course Objective:

  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Understand the Design Control Process
  • Use of Risk Assessment/Management Techniques
  • Identify Best Practices
  • Prepare a Plan for Inspection Readiness

Areas Covered

In this webinar, we will cover:

  • Overview and Definitions
  • FDA Expectations, Regulations
  • Design Control Process
  • Planning
  • Design Inputs
  • Design Outputs
  • Verification
  • Validation
  • Design Review
  • Design Transfer
  • Design Changes
  • Design History File
  • Linkages to other Quality System Requirements
  • Lessons Learned and Enforcement Case Studies
  • Best Practices
  • Preparing for an FDA or NB Inspection

Who will Benefit

  • R&D Engineers and Scientists
  • R&D Managers and Directors
  • Individuals participating in Product Design and Development
  • Individuals participating in design changes and failure investigations
  • Regulatory Affairs
  • Design Quality Engineers
  • CAPA Specialists
  • Compliance Specialists
  • Auditors
  • Senior Management

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Susanne Manz

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. 

Specialties: Quality, Compliance, Six Sigma, Lean Sigma, Quality Systems Development, ISO13485, ISO14971, GMP, QSR, CFR820, Quality Systems Auditing, Supplier Audits, Due Diligence, Predictive Compliance,Training and Education, FDA and Notified Body Inspection Readiness, Risk Management and Mitigation, Management Review, Quality Improvement, Supplier Management, Supplier Auditing, Process Validation, Problem Resolution, 483 / Warning Letter responses and mitigation.

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