Course "Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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 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

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

Speaker:

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.

Location:Las Vegas, NV Date: October 5th & 6th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton Las Vegas Airport 7250 Pollock Drive Las Vegas, NV USA 89119

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 20, Early Bird Price: $1,295.00 From August 21 to October 03, Regular Price: $1,495.00

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

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

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NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

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