Device Manufacturing Compliance Crash Course Solutions to the Top 10 QSR Violations
Product Details
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
- CAPA procedures, 820.100 (a)
- Compliant procedures, 820.198 (a)
- Written MDR procedures, 803.17
- CAPA documentation, 820.100 (b)
- Process validation, 820.75 (a)
- Device master record, 820.181
- Purchasing controls, 820.50
- Control of non-conforming product, 820.90 (a)
- Quality audit procedures, 820.22
- 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)