$1,285 – $7,112

Design Controls for Medical Devices - Regulations, Myths, Challenges, and B...

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DoubleTree by Hilton Hotel Las Vegas Airport

7250 Pollock Drive

Las Vegas, NV 89119

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Description

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company.

Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And design problems can have disastrous results for your customer and for your company.

In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company. We'll cover the history and requirements for design controls. Then we'll discuss requirements and tools in detail and include exercises to help you practice and improve your design control process.


Why should you attend:

Poor design of medical devices accounts for a significant number of recalls. Design issues can result in complaints and medical device reports. Design issues can even create issues with manufacturability for your company including low yields and excessive scrap and rework. Finding and fixing issues early on in design provide much more leverage than trying to fix problems for products already in production. This webinar can help you learn from past issues and improve your next generations of product.


Areas Covered in the Session:

  • Expectations
  • Regulations
  • Process
  • Lessons Learned
  • Myths
  • Challenges
  • Best Practices
  • Inspection Readiness

Who Will Benefit:

  • R&D Engineers
  • 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
  • R&D engineers and scientists
  • Compliance Specialists
  • Auditors
  • Senior Management


Day 1 Schedule


Lecture 1:

  • Overview and Expectations

Lecture 2:

  • Design Planning
  • Design Inputs

Lecture 3:

  • Design Outputs

Lecture 4:

  • Design Verification and Validation

Day 2 Schedule


Lecture 1:

  • Design Review

Lecture 2:

  • Design Transfer and Design Changes

Lecture 3:

  • Design History File
  • Linkages to Other Quality Sub-systems
  • Inspection Preparedness

Lecture 4:

  • Myths
  • Challenges
  • Best Practices


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 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Date and Time

Location

DoubleTree by Hilton Hotel Las Vegas Airport

7250 Pollock Drive

Las Vegas, NV 89119

View Map

Refund Policy

No Refunds

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