Device Manufacturing Compliance Crash Course Solutions to the Top 10 QSR Violations

Held Dec. 19, 2012
FDA inspectors are focusing their attention on very specific violations within device and diagnostics companies. And it’s showing up in 483s and warning letters. 

Here’s a Top 10 list you don’t want to be on:

Top 10 FDA Form 483 Citations for Medical Device Firms for Last Year

  1. CAPA procedures, 820.100 (a)
  2. Compliant procedures, 820.198 (a)
  3. Written MDR procedures, 803.17
  4. CAPA documentation, 820.100 (b)
  5. Process validation, 820.75 (a)
  6. Device master record, 820.181
  7. Purchasing controls, 820.50
  8. Control of non-conforming product, 820.90 (a)
  9. Quality audit procedures, 820.22
  10. Design change procedures, 820.30 (i)

Tackle these 10 problems and assure smooth sailing through your next inspection.

Listen to the audio CD/Transcript that will give you concrete knowledge and solutions to the top 10 mistakes device manufacturers are currently making.

Master device manufacturing compliance in just one day.  Here’s how.

Featuring six speakers focusing on the trends, FDA regulations and best practices for avoiding mistakes, listeners will come away with ideas on how to transform their device manufacturing compliance problems.

Get answers to your toughest questions — in just a day.  No travel required.  Gather your colleagues for the best, and most cost effective, training in the industry.

The chairperson is James Wason, Ph.D, principal of Maelor Group Lifesciences Consulting. Dr. Wason has more than 35 years of experience working with device manufacturers.

Order Device Manufacturing Compliance Crash Course today.

Meet Your Instructors

Judith Andrews, Director of Quality and Compliance Services, Aptiv Solutions

Deb Lydick, President, Catalyst Advantage Group LLC

Vinny Sastri, Ph.D, President, WINOVIA® LLC

John Freije, Principal Medical Device Consultant, Freije Quality Engineering, LLC in cooperation with:
Jim Shore, Product/Process Improvement Leader, Dynisco LLC

Karl Vahey, Senior Director RA Compliance, International RA/QA, Covidien

Judith Meritz, Associate General Counsel, Covidien

James Wason, Ph.D, Principal, Maelor Group Lifesciences Consulting (Chair)

  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Engineering and design control teams
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory affairs professionals
  • Risk management specialists
  • Training personnel

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600