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FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD

Falls Church, VA (PRWEB) August 14, 2014

Innovative Process Validation Strategies for Medical Devices:
Proving Your Processes and Documentation to the FDA
**Presented by Ombu Enterprises and FDAnews**
Aug. 26-27, 2014 – Bethesda, MD

The quality plan has been reviewed and it’s time to focus on production processes. However, the review raises a question about which processes need process validation. But not to worry, because there is the new FDA guidance document.

The plan is to download, read it, and follow its advice. The CDRH search engine shows there is no device guidance document!

The “FDA guidance document” is for pharmaceuticals, biologics, and veterinary medicine. FDA does not have a guidance document for devices.

A colleague suggests brushing up on statistics, because process validation includes statistical techniques. The GHTF guidance document is an option, but it looks complex.

It is necessary to understand the issues from the regulatory requirements to the applications that would help build the system.

Hands-on training is needed. Introducing, Innovative Process Validation Strategies for Medical Devices Workshop — Proving Your Processes and Documentation to the FDA. This interactive workshop presented by Ombu Enterprises and FDAnews is being held Aug. 26-27, 2014 at the Marriott Bethesda North Hotel and Conference Center in Bethesda, MD.

Attendees will learn:

  • The concepts of process validation including a distinction between product verification and process validation
  • The requirements in QSR and how to understand them
  • The relationship between QSR and ISO 13485:2003
  • Using QSIT to help implementation
  • The issues raised by recent warning letters and how they can help guide the approach
  • The role of Installation Qualification (IQ) and the relationship with OSHA regulations
  • Understanding process capability and its role in defining an effective process
  • Understanding how Operational Qualification (OQ) determines process validation
  • The role of Performance Qualification (PQ)
  • Production issues for validated processes

Who Will Benefit:

  • Project managers involved in design and development
  • Design engineers
  • Quality engineers
  • Manufacturing engineers
  • Quality auditors
  • Production managers
  • Production supervisors
  • Scientists involved in device R&D and manufacturing
  • Training personnel
  • General/corporate counsel
  • Production engineers
  • Risk management specialists

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 now 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:
Innovative Process Validation Strategies for Medical Devices:
Proving Your Processes and Documentation to the FDA
**Presented by Ombu Enterprises and FDAnews**
Aug. 26-27, 2014 – Bethesda, MD

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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