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FDAnews Announces: Medical Device Design Control: Implementing an Approach That Works, June 16-17, Chicago, IL

Falls Church, VA (PRWEB) April 28, 2015

Medical Device Design Control
Implementing an Approach That Works
**Presented by FDAnews and Ombu Enterprises**
June 16-17, 2015 – Chicago, IL

If an FDA inspector came to a facility today, would the design control system pass with flying colors?

If the answer is "maybe" or "no" … then very likely there is a problem. Fortunately, Ombu Enterprises and FDAnews have a solution.

Take this important step. Enroll TODAY to attend the interactive workshop Medical Device Design Control: Implementing an Approach That Works in Chicago on June 16-17, 2015.

Attendees will have the opportunity to gain a greater understanding of the issues confronting them from Dan O’Leary, an expert in quality, operations and program management … as well as benefit of hearing from and discussing the issues with other attendees who face the same challenges every day.

With Dan taking the lead, attendees will learn requirements, develop approaches and find out how to execute them through a series of exercises prepared especially to simulate real-life scenarios.

Using examples and case studies, attendees will deepen their understanding of design controls and find out how to develop procedures that accurately define and document the approach.

Since many device manufacturers market in the US, the EU and Canada, attendees will learn the similarities and differences in the requirements of the three regions, so they can develop a fully comprehensive system that includes them all.

And to enhance understanding, many presentations will feature recent warning letters to illustrate potential problems and help attendees learn from the mistakes of others.

Attendees will learn:

  •     The regulatory basis for design controls in the US, the European Union and Canada
  •     Methods of design planning based on project management techniques
  •     Developing sources of design input and resolving problems
  •     The role of design output and methods to ensure it is complete
  •     How to conduct design reviews that help improve the device design
  •     Using design verification methods to match design output with design input
  •     Conducting design validation and its critical elements of software validation and risk management
  •     Implementing the 5 vital components of design change

This two-day workshop is a rare opportunity to "get up close and personal" with an acknowledged expert … to rub elbows with colleagues who daily encounter the same issues that you do … to pick their brains … absorb their knowledge … and develop contacts that'll be invaluable all through the year.

Who Will Benefit

  •     Quality Managers
  •     Regulatory Affairs Managers
  •     Engineering Managers
  •     Quality Engineers
  •     Production Engineers
  •     Purchasing Managers
  •     Purchasing Agents involved in outsourcing production or processes
  •     Design Engineers
  •     Project Managers involved in design and development
  •     Specialists assigned to complaints, corrective actions or medical device reporting
  •     Recall coordinators
  •     Medical staff evaluating risk, safety or effectiveness
  •     General/corporate counsel

Meet the Instructor:

Dan O’Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices and clinical labs.

Dan is President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies.

He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Conference Details
Medical Device Design Control
Implementing an Approach That Works
**Presented by FDAnews and Ombu Enterprises**
June 16-17, 2015 – Chicago, IL

Tuition: $1,797
Significant team discounts are available.

Easy Ways to Register
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at

Source: PRWeb
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