Supplier Quality Management Congress Agenda
SPECIAL PRE-CONFERENCE WORKSHOP! 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:
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CONGRESS AGENDA
Day One: Thursday, Aug. 20, 2009 General Sessions |
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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 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.
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Inside the Development of GHTF SG3 — Managing Internal and External Suppliers 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.
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Two Concurrent Breakout Tracks |
5:15 p.m. – 7:00 p.m. |
Adjournment and Networking Reception |
TRACK 1 — DRUG & BIOLOGIC |
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11:15 a.m. – 11:30 a.m. |
Drug and Biologic Track Chair Comments |
11:30 a.m. – 12:15 p.m. |
Quality System Expectations for Disposables in the Manufacture of Drugs and Biologics
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. Attendees will:
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12:15 p.m. – 1:00 p.m. |
Utilizing Risk Assessment to Manage OEM/CMO Suppliers 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:
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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 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:
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2:45 p.m. – 3:30 p.m. |
Amgen’s China Supplier Strategic Plan: Securing the Raw Material Supply Chain — A Case Study
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.
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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 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 |
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11:15 a.m. – 11:30 a.m. |
Medical Device Track Chair Opening Comments |
11:30 a.m. – 12:15 p.m. |
Overcoming Customer-Supplier Barriers to Promote Effective Relationships: A Three-Point Plan You Can Implement Immediately Attendees will:
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12:15 p.m. – 1:00 p.m. |
Supplier Quality Management Alignment to the GHTF
SG3 Guidance: The Boston Scientific
Approach 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:
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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 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:
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2:45 p.m. – 3:30 p.m. |
How to Handle
Language Barriers — Lessons Learned
From New Delhi to New Jersey Attendees will:
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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 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 |
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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 |
9:00 a.m. – 10:00 a.m. |
Good Importer
Practices: Turning Guidance Into Governing Principles for Your Operations 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:
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10:00 a.m. – 11:00 a.m. |
Leveraging Supplier Audits Throughout a Global Organization: J&J Companies Case Study 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:
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11:00 a.m. – 12:30 p.m. |
Pharma and Device “Put Away the PowerPoint” Panel Discussion and Closing Comments 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 |