Harmonized QS                                                      

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Brought to you by Compliance-Alliance and co-sponsored by The University of Southern California, Underwriters Laboratories, and FOI Services

Creating a Globally Harmonized Quality System

USC Orange County Center
2300 Michelson Drive,
Irvine, CA 92612
July 16 – 17, 2008

Faculty

  • Richard DeRisio, VP, Global Regulatory Affairs, Advanced Medical Optics, AMO

  • Denise Dion, Regulatory Consultant Eduquest, Formerly with FDA’s Office of Regional Operations

  • Jonathan Lee, VP, RA, QA & Clinical Services, Medtronic ENT/NT

  • Alonza Cruse, Director, LA District, FDA

  • Tara Kambeitz, Global Marketing Manager, Medical Business Unit, Underwriters Laboratories (UL)

  • Robert Klepinski, Fredrikson & Byron

  • Steve McRoberts, Principal Engineer Regulatory Systems, UL

  • Bonnie Norman, Director RA/Quality Assurance, Intel Digital Health

  • Robin Norris, VP, Quality Systems, Siemens Healthcare Diagnostics

  • Virginia Perry, President, Perry-D'Amico and Associates

  • Ganesh Rao, General Manager, Management Systems Solutions, UL

  • Frances JR Richmond, Ph.D., Director of Regulatory Science Program, USC

  • Rod Patterson, Dir. Worldwide Quality Assurance, Advanced Medical Optics, Inc.

  • Javad Seyedzadeh, Senior VP RA/QA, Gambro

  • Nancy Singer, President, Compliance-Alliance

  • Emi Zychlinsky, VP R&D, Hitachi Chemical Diagnostics

Wednesday, July 16, 2008

8:00 - 8:30 - Registration and Continental Breakfast 

8:30 - Introductions and Welcome
 - Frances JR Richmond PhD, USC
 - Alonza Cruse, FDA

Challenges Firms Have in Complying  With the Quality System
 - Nancy Singer, Compliance-Alliance

  • Areas where firms have the most difficulty

  • Recent 483 observations and warning letters

  • FDA's new regulatory emphasis

Complying With Global Requirements for Quality Systems
- Steve McRoberts, Underwriters Laboratories

  • Key markets (Canada, EU, Japan, China and Brazil)

  • Areas that Quality System Registrars and Notified Bodies Audit

  • Common observations

  • How to avoid these observations

Having Standard Procedures throughout A Corporation
- Javad Seyedzadeh, Senior VP RA/QA Siemens Diagnostics

  • Why it is important to have standard procedures throughout an organization?

  • When a facility receives a 483 citation, what is the best way to communicate corrective action to other parts of the organization?

  • How to handle the procedures for facilities in other countries?

  • How to continually improve procedures?

12:00 - 1:00 Lunch

1:00 A panel of experts will comment on a case study where a company is about to acquire a new firm and they need to harmonize the quality system.
 - Richard DeRisio, Advanced Medical Optics
 - Jonatha Lee Medtronic ENT
 - Javad Seyedvadah, Gambro
 - Robert Klepinski Fredrikson & Byron
 - Denise Dion, Eduquest
 - Bonnie Norman, Intel Digital Health

  • What to look for during due diligence

  • How to select the staff to keep and those to let go

  • How to get people from the company that is being acquired on board

  • How to get the acquired company to accept the acquiring company’s quality system

  • What should the acquiring company do when they find skeletons in the closet of the acquired company

  • How the government or notified body will view the problems

The Quality System, Compliance and the Organization: Lessons Learned
-Jonathan Lee, Medtronic ENT/NT

  • Who are the two customers that need to be satisfied
  • How do you balance necessity with sufficiency

How to Harmonize Your Complaint and Adverse Reporting Systems
- Robert Klepinski Fredrikson & Byron (former regulatory attorney with Medtronic, Inc.)

  • Complaint handling under a harmonized quality system
  • Differences in international adverse event reporting
  • Different approaches for handling FDA investigators and notified body auditors

How to Use Your Quality System to Achieve Business Excellence
– Ganesh Rao, UL

  • Your quality system is meeting basic requirements, now what?
  • Determine which existing improvement activities to leverage.
  • Find out where your company’s linkages are weak.
  • Know what situations benefit from a cross functional team.
  • Identify the internal and external stakeholders that need to be engaged

5:00 - 6:00 Reception

6:00 - 7:15 Dinner


Thursday, July 17, 2008

8:00 - 8:30 - Continental Breakfast 

8:30 – 8:35 Welcome

Points to Consider When Selecting Suppliers and Service Providers
–Emi Zychlinsky Ph.D, Hitachi Chemical Diagnostics

  • Key elements in effective purchasing controls program
  • How and when to audit suppliers
  • What to do if your suppliers are not meeting their obligations
  • How to handle 483 observations for failure to audit supplier

How to Use Internal Audits to Ensure Regulatory Compliance - Denise Dion, Eduquest

  • How to set the stage for the audit
  • Key characteristics of an effective auditor
  • How to use the findings to your advantage

Exercise:  Challenges of Working with Notified Bodies

Challenges in Creating One Quality System Throughout an International Corporation
 - Rod Patterson, Advanced Medical Optics, Inc. (AMO)

  • The challenge of balancing a common quality system with the needs of individual business units
  • Areas where a common system makes sense
  • Area where individual systems are more efficient
  • How to measure the effectiveness of your quality initiatives and make change

Lessons Learned in Implementing a Successful Integrated Organization
 – Robin Norris, Siemens Healthcare Diagnostics

  • How the firm got there
  • The attributes of the integrated organization
  • How integration has contributed to the firm’s success

12:00 Adjournment