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

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$1,297.00
1 - 9999
$897.00
1 - 9999
$1,297.00
1 - 9999
$897.00
 
 
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.

Join FDAnews for this encore presentation 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, attendees 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.

Your encore presentation 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.

Register Today

The encore presentation is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Everyone in your organization with a role in product development, legal and regulatory affairs will benefit from taking part in this event — and they can do so at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

Sign up for 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
Date: Dec. 24, 2012 – Jan. 11, 2013
Location: Your office or conference room (no need to travel!)
Time: Anytime

Send Your Team for Maximum Benefit
Get your team up to speed!

Significant tuition discounts are available for teams of three or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
globally with any questions.

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Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Cancellations/Substitutions
Registrations may not be cancelled. Please contact Customer Service to make any substitutions.