Risk Management in Medical Device Design 2016

NetZealous DBA as GlobalCompliancePanel, San Diego, CA
13-10-2016

Overview:

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 seminar 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

Agenda:

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.

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 

Until September 10, Early Bird Price: $1,295.00 from September 11 to October 11 Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00       $6,475.00 You Save: $2,590.00 (40%)*

Until September 10, Early Bird Price: $6,475.00 from September 11 to October 11, Regular Price: $7,475.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com

Registration Link -  http://bit.ly/2bLjy5K-FDA-Concepts-for-Medical-Device