Fourth Annual Supplier Quality Management Congress

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1 - 9999
1 - 9999
1 - 9999


Do these questions sound familiar?

  • “We deal with a lot of companies with satellite plants. Should we have one global quality agreement with the headquarters or one for each facility?”

  • “Our quality requirements are stated on the back of the purchase orders as standard boilerplate. Is that an adequate quality agreement?”

  • “I'm being told to accept materials that were shipped prior to a quality agreement being in place? Is this OK?”

  • “MHRA plans to inspect one of our API suppliers. In addition to the quality system, they also want to review product specific compliance? How should we prepare for that?”

  • “My suppliers are small. How can I expect them to meet quality requirements?”

At FDAnews we hear questions like this every day from drug- and devicemakers. And the questions are only going to get more complicated; Congress just gave the FDA expanded authority under GMPs to police supplier quality agreements.  What will that mean? What are the answers to all these questions?

There’s one place the industry has turned for years for answers: The Supplier Quality Management Congress. Pack up your toughest questions, and join us for this year’s conference, July 31 – Aug. 2, 2012, in Bethesda, MD.

It’s a day and a half of intensive learning, a crash course in supply chain management and monitoring. Here’s just a taste of what you’ll discover:

  • Update on supply chain regulation signed by President Obama
  • Best practices for managing risk in the supply chain
  • Import holds and the impact of the FDA’s PREDICT system
  • Qualification techniques for international suppliers
  • How to apply lean principles to supplier assessment criteria

Your faculty is an all-star cast of industry executives, members of the bar, consultants and invited FDA officials, including:

  • Jay Crowley, Senior Advisor for Patient Safety, CDRH, FDA
  • Melissa Torres, Biomedical Engineer, Office of Compliance, CDRH, FDA
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding
  • Sara Dyson, Assistant Vice President, Medmarc Insurance Group
  • Jonathan Lee, President, Medical Device Consulting Solutions International
  • Elaine Dymond, Vice President of Quality, Catelent Pharma
  • Stephen Amato, Managing Director, tJun 17 Life Sciences
  • Sean Ryan, Global Supplier Quality Manager, Welch Allyn
  • Jason Spiegler, Director, Business Development, Camstar Systems
  • Fred Malcolm, Director of Quality Engineering, Siemens Enterasys Networks
  • Peter Johns, Supplier Quality Manager, Pioneer Surgical
  • Bob Khin, Quality Assurance Director, Banner Medical
  • Vince Adams, Vice President for Sales, Marketing & Strategic Planning, Banner Medical
  • Mike Heyl, Partner, Hogan Lovells, Washington, DC
  • Dan O’Leary, President, Ombu Enterprises
  • Jim Darnell, President, QualiFactor Solutions LLC
  • Siobhan O’Bara, Vice President, GS1 Healthcare
  • Casper Uldriks, Counsel, Olsson Frank Weeda Law
  • Alan Minsk, Partner, Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP
  • Lynn Scott, Partner, Corporate Practice Team, Arnall Golden Gregory LLP

Conference chairman John Avellanet of Cerulean Associates LLC will be on hand to keep matters on track and moving forward.

Invaluable Pre-Conference Workshops
Register today and take advantage of the in-depth instruction at our two pre-conference workshops on Tuesday, July 31.

Workshop A
Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation
Dan O’Leary, President, Ombu Enterprises
John Avellanet, Principal Consultant, Cerulean Associates (Co-chair)

Regulators around the globe are looking more closely at supplier management issues as device manufacturers extend their processes down the supply chain and acquire components across national boundaries.

Are you ready for the increased scrutiny from FDA investigators and Notified Bodies?
You can start to prepare with important GHTF guidance documents:

  • Control of Suppliers (GHTF/SG3/N17:2008),
  • Risk Management Principles in a QMS (GHTF/SG3/N15R8), and
  • Corrective Action & Preventive Action in a QMS (GHTF/SG3/N18:2010)

But they only provide the foundation, not the practical details. This workshop gives you the tools and methods you need for a cost-effective implementation. Attendees will learn:

  • The shape of the industry and current trends
  • The overall process and the major steps involved
  • Principles of risk management applied to supplier qualification and controls
  • The role of basic and advanced questionnaires to get the information you need
  • How to conduct an on-site supplier audit applying risk management
  • The issues presented by virtual suppliers
  • How to select and apply supplier metrics and their role in the QMS management review
  • Producing records and issues with their retention

BONUS: Attendees will receive copies of implementation tools, including a process map, sample questionnaire, reevaluation form, audit checklist and more.

Workshop B
Do’s and Don’ts for Implementing Effective Quality Agreements
Alan Minsk, Partner, Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP
Lynn Scott, Partner, Corporate Practice Team, Arnall Golden Gregory LLP

Quality agreements are becoming more prevalent and expected of companies from the FDA and business partners to have in place. It is crucial to prepare an agreement to ensure regulatory compliance, and to define the roles of all parties involved to maximize use of time and minimize confusion between partners.

Attendees will:

  • Mistakes made in the quality agreement drafting process
  • Recommendations to maximize the benefits of quality agreements
  • What is expected from both parties in a quality agreement

Register Today

Live on-line viewing of the entire 4th Annual Supplier Quality Management Congress

Can’t make it to the 4th Annual Supplier Quality Management Congress? Attend the live sessions from your computer. Participate in the live conference from your home or office. Watch the live-streaming video of the presenter and view the presentation materials in real time. Ask questions of the presenters and download handout materials. By registering you will also receive six months’ access to archived session recordings after the conference ends. Registration is quick, and accessing the live sessions is as simple as clicking your mouse.

2011 Video Highlights:

Highlight: Why is the FDA Conferenced About Purchasing Controls and Supplier Management?
Conference: Third Annual Supplier Quality Managment Congress, August 9, 2011, Bethesda, MD
Speaker: Kim Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA
Presentation: Supplier Controls - The Latest FDA Medical Device Requirements
Time: 1 minute, 31 seconds

Highlight: Are USP Test Methods Enough for In-bound Materials? What’s on the Horizon?
Conference: Third Annual Supplier Quality Managment Congress, August 9, 2011, Bethesda, MD
Speaker: Londa Ritchey, Director, Supplier Qualification, Pfizer
Presentation:  Real-Time Risk Profiles of GMP Material Suppliers - An Essential Supplier Quality Risk Management Tool
Time: 1 minute, 38 seconds

  • Quality assurance/quality control
  • Operations
  • Manufacturing
  • Materials management
  • Purchasing
  • Packaging and labeling
  • Plant engineering
  • Laboratory quality control
  • Regulatory affairs
  • Legal counsel

John Avellanet, Principal Consultant, Cerulean Associates
John Avellanet is a former medical device and biopharma executive who created, developed and ran a Fortune 50 subsidiary's records management and information technology departments. He co-founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on lean FDA compliance and FDA/ICH Quality by Design.  He is a regular columnist for the quarterly Journal of Commercial Biotechnology, where he writes on the practical aspects of compliance, quality systems and preventing industrial espionage, and the magazine Pharmaceutical Processing, where he writes about IT compliance issues, such as Part 11 and Annex 11.

Register Today.

2012 Sponsors:


For 2012 exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or

2012 Venue:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, MD 20852
Toll free: (800) 859-8003
Tel: +1 (301) 822-9200

Register Early — Space Is Limited

Hurry — register early because space is limited! Your tuition includes the day-and-a-half summit, all summit materials, continental breakfast each day and lunch on the first day.

Regular Fee
July 18 – Aug. 2, 2012
Congress and Workshop
Congress Only
One Workshop
Livestreaming Full Conference
(including 24/7 access to the content for six months after the event)

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

Significant tuition discounts are available for teams of two 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.

2-4 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.

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

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

Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.