Supplier Quality Management Congress Agenda

SPECIAL PRE-CONFERENCE WORKSHOP!
Creating Quality Agreements That Assure Nothing Falls Through the Cracks
Wednesday, Aug. 19, 2009 • Registration 12:00 p.m. - 1:00 p.m. • Workshop 1:00 p.m. - 5:00 p.m.

Presenter: Arvilla Trag, President, Midwest Consulting Services

A quality agreement is a written contract between client and supplier delineating responsibilities and quality expectations in advance of and in addition to the supply agreement. It is intended to prevent critical details from “falling through the cracks.”

While these contracts are required by regulations and guidance, expectations for them are not clear. Instructions in both ICH Q7A 16.12 and the FDA Globalization Act are vague. But lack of clear agency expectations does not preclude Form 483 observations regarding the quality agreement.

This special workshop will examine the content and format of quality agreements, emphasizing important but often overlooked details. Tools to build a document that addresses both parties’ expectations will be discussed. Case studies of actual quality agreements will be presented to illustrate variation in content and format; show strengths and weaknesses; and illustrate consequences of an inadequate quality agreement.

Attendees will:

  • Employ the prospective source audit report and EIRs to determine what areas of the quality agreement need particular attention
  • Learn how to use the process flow diagram to identify critical control points and tasks that need to be addressed in the quality agreement
  • Learn the critical importance of a definitions section — why one person’s batch record is another person’s data sheet
  • Discover how to avoid potential quality problems by identifying and addressing them in advance
  • Specify operational expectations within the limits of each party’s capabilities — making sure each party can do what is expected/needed/wanted
  • Learn special considerations for quality agreements with ex-U.S. CMOs — “Never expect to start a campaign in August”
  • Analyze and compare case studies of three actual quality agreements, illustrating the degree of variation, strengths and weaknesses of each

CONGRESS AGENDA

Day One: Thursday, Aug. 20, 2009

General Sessions

8:00 a.m. – 8:45 a.m.

Registration and Continental Breakfast

8:45 a.m. – 9:00 a.m.

Welcome and Introduction by Chairperson John Avellanet, Managing Director & Principal Consultant, Cerulean Associates

9:00 a.m. – 9:45 a.m.

CDER’s Supplier Quality and Compliance Outlook
Barry Rothman, Compliance Officer, Guidance and Policy, Division of Manufacturing & Product Quality, CDER, FDA

The FDA has been actively focusing on protecting the integrity of raw materials and the supply chain for drugs, biologics and devices. Understanding the FDA’s approach is essential to ensuring compliance and avoiding problems. In this session, Mr. Friedman will take you through the latest FDA policies and processes.

9:45 a.m. – 10:30 a.m.

 

Inside the Development of GHTF SG3 — Managing Internal and External Suppliers
Kimberly Trautman, Medical Device Quality System Expert, Office of Compliance, CDRH, FDA

Companies that have corporate quality policies do not necessarily place all divisions under the same quality management system. One division may be an internal supplier to another division within the same company. Internal suppliers are to be controlled similarly to the way external suppliers are controlled. Ms. Trautman will present and discuss the GHTF SG3 guidance document and its impact on internal and external suppliers. She also will focus on the eight phases of supplier control: planning, selection of suppliers, evaluation, controls, delivery, measurement, monitoring and feedback (including CAPA).

10:30 a.m. – 11:15 a.m.

Refreshment Break

11:15 a.m. – 5:15 p.m.

 

Two Concurrent Breakout Tracks
Track 1 — Drug and Biologic
Track 2 — Medical Device

5:15 p.m. – 7:00 p.m.

Adjournment and Networking Reception

TRACK 1 — DRUG & BIOLOGIC

11:15 a.m. – 11:30 a.m.

Drug and Biologic Track Chair Comments
Costas Chantzis, Principal Consultant, TechnoBusiness Solutions

11:30 a.m. – 12:15 p.m.

Quality System Expectations for Disposables in the Manufacture of Drugs and Biologics
Bill Holden, Global Quality Leader, Gore PharmBIO Products, W.L. Gore & Associates

As manufacturers move to disposable technologies, they become more reliant on outside suppliers. With the large number of suppliers offering a wide range of technologies that are rapidly changing and developing, it is important to assess the risks and understand the expectations on the pharmaceutical industry.
To ensure quality each supplier must be evaluated on their ability to provide long-term service, support and quality.

Attendees will:

  • Apply cGMP quality system regulation standards to suppliers of disposables to control and mitigate risk
  • Evaluate suppliers of disposable techno-logies and establish expectations for them to fully comply with cGMP requirements
  • Define minimal quality standard expectations that are used in the manufacturing process of drugs and biologics with disposables

12:15 p.m. – 1:00 p.m.

Utilizing Risk Assessment to Manage OEM/CMO Suppliers
Jackie Torfin, Director, Quality Compliance, Medicis Pharma

Managing OEM/CMO suppliers can drain resources, especially with the recent scrutiny and emphasis on ensuring that manufacturers truly understand and control their contract deliverables. By using your current quality systems, common sense and risk principles, you can ensure that the right amount of control is exercised over these key supply-chain partners.

Attendees will:

  • Understand how to incorporate elements of supplier management into current quality systems
  • See a way to implement risk assessment principles to improve supplier management
  • Review case studies of risk-based supplier management

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

How to Convert Supplier Quality-Related CAPA Challenges Into Tangible Benefits and Competitive Advantage
Costas Chantzis, Principal Consultant, TechnoBusiness Solutions

When your supplier’s raw materials fail specific requirements and you desperately need the material — what do you do? When you are unable to follow your SOP but your company pressures you to deviate from it and either ship now or pay a late-shipment penalty — what do you do? When you get an out-of-specification (OOS) test result — what do you do? When your employees follow your company’s quality systems but critical errors still occur — what do you do?  This session will answer these and many more pressing concerns drug and biologic manufacturers face every day.

Attendees will:

  • Discover successful CAPA strategies using real-world case studies
  • Learn 3 tools that aid in investigating supplier concerns and strategies for resolving problems
  • Understand how to close the loop and assure that supplier controls are effective

2:45 p.m. – 3:30 p.m.

Amgen’s China Supplier Strategic Plan: Securing the Raw Material Supply Chain — A Case Study
Cynthia Ely, Supplier Quality Management, Amgen

Alarming world events concerning materials originating from China have elevated Amgen's concern about the security of its raw material supply chain. Amgen's Supplier Quality Management (SQM) has initiated actions to assess the security of this supply chain and is surveying suppliers to discover whether any materials are sourced directly or indirectly from China or other emerging markets that represent an increased risk to Amgen, its processes or the safety of its patients. Ms. Ely will explore the use of an internal quality system for risk evaluation, documentation and remediation of the risks associated with securing the supply chain.
 
Attendees will:

  • Discover how missteps in the raw material supply chain can affect other operations
  • Learn how to set up quality surveillance processes and take proactive steps to mitigate risks
  • Understand how to develop documentation requirements to assure that suppliers meet quality standards

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 5:15 p.m.

Drug and Biologic “Put Away the PowerPoint” Panel Discussion
Moderated by Costas Chantzis, Principal Consultant, TechnoBusiness Solutions
Alexandra Dills, GxP Principal Consultant, ARD Scientific
Jim Darnell, President/Founder, CompliaPharm
Joel Grosser, Senior Procurement Consultant, RAS Associates International

No PowerPoint presentations in this interactive panel discussion — just a frank discussion and exchange of ideas! No one has the right answer to supplier quality problems plaguing the drug and biologic industries. Bring your toughest problems and most pressing concerns to share with panel experts and your peers. We’ll also reserve time at the end to discuss the day’s highlights.

TRACK 2 — MEDICAL DEVICE

11:15 a.m. – 11:30 a.m.

Medical Device Track Chair Opening Comments
John Avellanet, Managing Director & Principal Consultant, Cerulean Associates

11:30 a.m. – 12:15 p.m.

Overcoming Customer-Supplier Barriers to Promote Effective Relationships: A Three-Point Plan You Can Implement Immediately
Mike Fedock, Senior Supply Quality Engineer, St. Jude Medical
Like other significant relationships, a healthy customer-supplier relationship requires communication, compromise and commitment. Both parties may be well suited and well intended in the beginning, but goodwill can dissolve once conflicts and differences emerge. This presentation will offer examples and strategies to overcome barriers and promote effective supplier relationships.

Attendees will:

  • Discover best practices for cultivating effective customer-supplier relationships
  • Spot the pitfalls: what can — and often does — go wrong
  • Pick up 5 tips for becoming a more effective customer and supplier
  • Come home with a plan: 3 things to put into place the week you return to your office

12:15 p.m. – 1:00 p.m.

Supplier Quality Management Alignment to the GHTF SG3 Guidance:  The Boston Scientific Approach
Jim Shore, Principal Design Assurance Engineer, Boston Scientific
Steve McKenna, Senior Quality Manager, Boston Scientific

The Global Harmonization Task Force Study Group 3 (GHTF SG3) released its final guidance for managing medical device suppliers in December 2008. Since that time, firms have been working on gap analysis to see how they stack up against the guidance recommendations. This presentation will examine the elements of the guidance documents and demonstrate how compliance can be achieved as well as best practices in several areas.

Attendees will:

  • Understand the nuances of the GHTF SG3 guidance document
  • Learn how to perform a gap analysis of your existing QMS to the guidance document
  • Discover best practices from implementation into product development and through commercialization

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

Little Fish in a Big Pond: Creating Leverage With Your Supply Base
Ryan Sproul, Supplier Quality Engineer, Gyrus Medical — An Olympus Company

As a small- or mid-sized medical device manufacturer, it can be challenging to get the desired attention from large suppliers. With increasing quality requirements on medical suppliers, it is critical to create leverage with your supply base. In lieu of the relatively low volume of business from most device manufacturers vs. consumer goods customers, here are strategies to help increase your presence with suppliers.

Attendees will:

  • Learn to select the right vendors for their businesses
  • Examine how to choose the right level of communication
  • Create product application awareness
  • Evaluate price vs. cost of quality

2:45 p.m. – 3:30 p.m.

How to Handle Language Barriers — Lessons Learned From New Delhi to New Jersey
Parag Jhaveri, Senior Quality Management Engineer, Becton Dickinson
With companies taking the next step to becoming global, and as the U.S. becomes increasingly diverse, medical device organizations struggle with language barriers. We’ll examine challenges and approaches to overcoming language barriers to improve supplier communications and ultimately the patient experience and health outcomes.

Attendees will:

  • Learn how language barriers may affect safety and quality
  • Understand the importance of non-English material, translation services and visual aids
  • Review experiences, lessons learned and success stories from various organizations

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 5:15 p.m.

Medical Device “Put Away the PowerPoint” Panel Discussion
Moderated by John Avellanet, Managing Director & Principal Consultant, Cerulean Associates
Jim Shore, Principal Quality Engineer, Boston Scientific
Dan O'Leary, President, Ombu Enterprises
Parag Jhaveri, Senior Quality Management Engineer, Becton Dickinson

The panelists take off the gloves for a frank end-of-conference discussion. No PowerPoint presentations — just an idea free-for-all about vexing problems of medical device supplier quality. Here’s where you air your toughest problems and most pressing concerns for feedback from our expert panelists and your peers. The conference ends with time to discuss the highlights of the day.

Day Two: Friday, Aug. 21, 2009

8:00 a.m. – 8:45 a.m.

Registration and Continental Breakfast

8:45 a.m. – 9:00 a.m.

Welcome and Introduction by Chairperson
Costas Chantzis, Principal Consultant, TechnoBusiness Solutions

9:00 a.m. – 10:00 a.m.

Good Importer Practices:  Turning Guidance Into Governing Principles for Your Operations
Steve Niedelman, Senior Consultant, Crowell & Moring

In January 2009 the FDA released draft guidance on good importer practices. The guidance is intended to provide suggestions importers can take to help ensure imported products comply with applicable U.S. statutes and regulations. The FDA closed the comment period on the draft April 12 and is currently working on the final version. Former FDA official and regulatory expert Steve Niedelman will describe the FDA's thinking on this guidance and how you can put these principles into action in your company.

Attendees will:

  • Analyze the draft guidance language and the submitted comments from industry
  • Review the 4 guiding principles and how to put these into practice within your operation
  • Discover pilot programs from the FDA and industry aimed at improving supplier quality and supply-chain integrity

10:00 a.m. – 11:00 a.m.

Leveraging Supplier Audits Throughout a Global Organization: J&J Companies Case Study
Ruth Barnett, Quality & Regulatory Project Leader, Ethicon

Several Johnson & Johnson operating companies were looking for a solution that could leverage a highly decentralized supplier audit function. The goal was to maximize effectiveness of supplier audits and satisfy various decentralized supplier quality functions while minimizing budget, travel and interruption at the suppliers.

Attendees will:

  • Learn how J&J used Six-Sigma and Kaizen tools to determine the scope of the issue
  • Review results of a pilot run undertaken to gauge effectiveness
  • Discover steps and timeline taken to implement the changes

11:00 a.m. – 12:30 p.m.

Pharma and Device “Put Away the PowerPoint” Panel Discussion and Closing Comments 
Moderated by Costas Chantzis, Principal Consultant, TechnoBusiness Solutions and John Avellanet, Managing Director & Principal Consultant, Cerulean Associates
Doug Ellett, Global Strategic Sourcing Manager, Covance Central Laboratory Services, Inc.
Ruth L. Barnett, Quality & Regulatory Project Leader, Ethicon
Cynthia Ely, Supplier Quality Management, Amgen

The final panel discussion of the conference — your moment to review highlights, get answers to nagging questions and pick the brains of expert panelists and your fellow attendees. Highlight: Discussion of the single most interesting idea or strategy you and other attendees plan to bring back to your companies.

12:30 p.m.

Adjourn