GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
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Quality by Design – Essential Techniques for Medical Devices

Start Date : November 12, 2018
End Date : November 13, 2018
Time : 9:00 am to6:00 pm

Phone : 18004479407
Email : globalcompliancepanel@gmail.com

Location :
DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA

Website

Description

 


Course "Quality by Design - Essential Techniques for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


Description:


Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This two-day seminar will help you understand, develop, and implement Design Controls processes and tools that are a competitive strength for your company. You will learn how to incorporate Design Controls into your product development process to help streamline development and ensure Quality and compliance.


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, context, 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 you should attend:


The intrinsic quality, safety, and effectiveness of medical devices are established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And those design problems can have disastrous results for your customer and for your company. A rigorous and efficient Design Control process can help avoid these quality and compliance problems. Issues that are identified early are more easily and quickly resolved. This seminar will help you avoid design problems and their impact on Quality, cost, speed to market, and customer satisfaction.


Design Control is one of the critical areas covered by the FDA in inspections of medical device companies. Design issues can also result in complaints from your customers and in 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.




Learning Objectives:


Using interactive discussion and exercises, students will understand the regulations, context, and history of Design Controls. They will learn how to use Design Control as a tool to ensure product quality while meeting business needs for speed to market. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference:





Who Will Benefit:



 


Agenda:


Day 1 Schedule




Lecture 1 (90 Mins):


Overview and Expectations


Background of FDA regulations


Design Controls as an integrated part of New Product Development




Lecture 2 (90 Mins):


Design Planning


Project Management


Design Inputs




Lecture 3 (90 Mins):


Design Outputs


Tools, forms, documents




Lecture 4 (90 Mins):


Design Verification and Validation



Day 2 Schedule




Lecture 1 (90 Mins):


Design Review


Design History File


Documentation Requirements




Lecture 2 (90 Mins):


Design Transfer


Design for manufacturability concepts


Design Changes


Change Control and configuration management




Lecture 3 (90 Mins):


Linkages to other quality sub-systems



Inspection Preparedness and Compliance Strategy




Lecture 4 (90 Mins):


Lessons Learned


Myths


Challenges


Best Practices


Speaker:


Susanne Manz


Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.



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 industry leaders like GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world conducting audits and helping companies to understand and improve their Quality Management Systems. 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, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.


 


Location:  San Diego, CA Date: November 12th & 13th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA


 


Price:


Until September 30, Early Bird Price: $1,295.00  Price: $1,295.00 (Seminar Fee for One Delegate)


From October 01 to November 10, 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%)*


 Register now and save $200. (Early Bird)


Sponsorship Program benefits for seminar


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


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link -  https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901813SEMINAR?seo


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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901813SEMINAR?meetings4docs-nov-seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC - DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
Tel: 8004479407
Email: globalcompliancepanel@gmail.com
Website: http://www.globalcompliancepanel.com





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