SQMC 2010 Agenda

Untitled Document

Pre-Congress Workshop

12:00 p.m. – 1:00 p.m.

Pre-Congress Workshop Registration

1:00 p.m. – 5:00 p.m.

Workshop A: Creating Comprehensive Medical Device Supplier Quality Agreements That Reduce Risk and Improve Contract Deliverables
A quality agreement is a written contract between client and supplier that is intended to prevent critical details from “falling through the cracks.” While these contracts are required by regulations and guidance, there are not clear expectations. The lack of clarity does not stop the FDA from issuing Form 483s regarding these agreements. This workshop will illustrate the content and format of quality agreements and emphasizes important but often overlooked details.
Attendees will:

  • Learn how to use a process flow diagram to identify critical control points and tasks that need to be addressed in the quality agreement
  • 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 and wanted

Dan O’Leary, President, Ombu Enterprises

1:00 p.m. – 5:00 p.m.

Workshop B: Creating Pharmaceutical Supplier Quality Agreements
While these contracts are required by regulations and guidance, there are no clearly outlined expectations for them. ICH Q7A 16.12 simply reads, “There should be a written and approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measures, of each party.” Case studies of actual quality agreements will be presented to illustrate how much variation there can be in content and format, to show strengths and weaknesses in the documents, and to illustrate the potential consequences of an inadequate quality agreement.

Attendees will:

  • Use tools to build a solid document that addresses the expectations of both parties
  • Discover how to avoiding potential quality problems by identifying and addressing them in advance
  • Specify operational expectations within the limits of each party’s capabilities — making sure the other party can do what you expect, need, and want

John Vajda, Managing Consultant, BFC Consultants


8:15 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:15 a.m.

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

9:15 a.m. – 10:15 a.m.

Catching Up to 21st-Century Challenges: FDA’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. This session will take you through the latest FDA policies and processes.

Carmelo Rosa, Division of Manufacturing & Product Quality, CDER, FDA

10:15 a.m. – 11:00 a.m.

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. Therefore, one division or group can be an internal supplier to another division within the same company. Internal suppliers are to be controlled in a similar way as external suppliers. Kimberly Trautman will present and discuss the GHTF SG3 guidance document and its impact on internal and external suppliers. The presentation will also focus on the six phases of supplier control including: planning, selection of suppliers, evaluation, controls, delivery, measurement, monitoring, and feedback (including CAPA).

Kimberly Trautman, Medical Device Quality System Expert, Office of Compliance, CDRH, FDA

11:00 a.m. – 11:15 a.m.

Networking and Refreshment Break

11:15 a.m. – 5:00 p.m.

Two Concurrent Breakout Tracks

  • Track 1: Medical Device
  • Track 2: Drug and Biologic

Track 1 — Medical Device

11:15 a.m. – 11:30 a.m.

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

11:30 a.m. – 12:15 p.m.

Establishing a Supplier Corrective Action Report (SCAR) Process
Firms are often unsure when to investigate a supplier and open a CAPA. In order to determine if a supplier issue is a correction or systemic one, firms should use a supplier corrective action report (SCAR). If a critical or systemic issue is found, a CAPA is opened and an investigation is started. The next steps of the process include verifying and validating the process and measuring the effectiveness of any action taken to address a root cause identified during the CAPA process.

Attendees will:

  • Learn to integrate a SCAR process that will aid in investigating supplier concerns
  • Uncover successful CAPA strategies for resolving real-world problems
  • Understand how to close the loop and
    assure supplier controls are effective

Steve Niedelman, Senior Consultant, Crowell & Moring

12:15 p.m. – 1:00 p.m.

Assessment Tool for Choosing the Right Subcontractor or Supplier
Choosing the right CMO or subcontractor to partner with will set the stage for your compliance and business relationship. Many partners are chosen based on filling out a questionnaire and a quote. Learn a new strategy using a quantitative risk assessment tool to help you make the right choice for your company’s business and compliance needs.

Attendees will:

  • Learn the areas of competency you should be assessing your suppliers on
  • Determine how to implement the assessment tool in more than one way in your organization
  • See the tool in action through an actual case study
Jackie Torfin, Director of Quality, Arizant Healthcare

1:00 p.m. – 2:00 p.m.


2:00 p.m. – 2:45 p.m.

Developing Supplier Quality Auditor Training Programs — Tips and Tricks Revealed
To have an effective supplier audit program, your company must have an effective audit team. Supplier audits are often performed either to begin a fruitful relationship or to save a teetering one. It is important that the audit team be trained to get as accurate a picture as possible of the supplier’s quality system, but also trained in the subtleties of appropriate supplier interaction. This presentation details effective methods for training auditors and includes tips and tricks for performing supplier audits.

Attendees will:

  • Discover successful methods for auditor selection and training
  • Train auditors how to perform supplier audits that will create beneficial relationships
  • Learn auditing tricks to keep in your back pocket when conducting on-site audits

Seth Mailhot, Latham & Watkins LLP; Former Compliance Officer and Medical Device Inspector, New England District Office, FDA

2:45 p.m. – 3:30 p.m.

Outsourcing Industry Trends: What Device Companies Are Doing to Make the Difference
What are your peers outsourcing and why? What have been the challenges they’ve faced?  Are quality departments helping or hindering and how? This presentation reviews the results of a 3-month survey of more than 13,000 medical device executives in the U.S., Canada and Europe. Understand why, unless changes are made in how we oversee our suppliers, supplier quality management will continue to suffer and firms will continue to get warning letter after warning letter.

Attendees will:

  • Discover which functions are being increasingly outsourced versus those least likely to be outsourced
  • Why regulatory affairs is on the chopping block
  • What is driving up the cost of supplier qualification and oversight
  • Examine challenges when dealing with the virtual partners and suppliers of today’s global landscape

John Avellanet, Managing Director, Principal Consultant, Cerulean Associates

3:30 p.m. – 3:45 p.m.

Networking and Refreshment Break

Track 2 — Drug and Biologic

11:15 a.m. – 11:30 a.m.

Drug and Biologic Track Chair Comments Jim Darnell, Managing Consultant, Tunnell Consulting

11:30 a.m. – 12:15 p.m.

Rogue APIs: Red Flags and Solutions
Contaminated and inadequate active pharmaceutical ingredients have caused many public safety concerns in recent years. The Heparin tragedy in 2008 taught the pharmaceutical industry many difficult lessons. There are now symptoms to identify in order to detect that something suspicious may be happening. This presentation identifies where to be looking for red flags and solutions to keep contaminated APIs out of your products.

Attendees will:

  • Recognize potential red flags including: drastic changes in costs and prices, raw material supply shortages, increased demand
  • Hear ways to reduce adulterated APIs getting past you
  • Learn how combined supplier audits can help

Huascar Batista, Team Leader of the Office of Compliance's Import-Export Team, FDA

12:15 p.m. – 1:00 p.m.

Case Study: Melamine Quality Risk Management
The FDA Guidance for Industry on Pharmaceutical Components at Risk for Melamine Contamination became effective August 2009. This guidance suggests that manufacturers of pharmaceuticals determine whether they are using components “at risk” for melamine contamination.  Melamine contamination can occur at the original manufacturing source or somewhere along the supply channel to the pharmaceutical manufacturing facility.  This presentation will demonstrate a method for determining if materials are at risk for melamine contamination inclusive of risk factor selection, and a scoring approach for melamine risk and supply channel integrity risk.  

Attendees will:

  • Learn one example of a Melamine Risk Management Program
  • Understand the process and rationale for selection of risk factors associated with Melamine Risk and Supply Channel Integrity Risk
  • View tools for risk assessment, risk evaluation and risk control related to Melamine Risk Management

Londa Ritchey, Director Supplier Quality, Pfizer

1:00 p.m. – 2:00 p.m.


2:00 p.m. – 2:45 p.m.

Creating Effective Supplier Qualification Management Systems For Drugs and Biologics
Supplier qualification programs can often become very complex and ineffective if you are not using the appropriate risk measurements. Firms should establish quantifiable criteria for prospective acceptance and then test the supplier against the given standards. Although this may sound simple and straightforward, many firms fail to achieve success judging warning letters and often unwanted audit results. This presentation will describe a simple program using a robust risk-based approach that can be used to benchmark your program or establish one that will be cost-effective and meet regulatory requirements.

Attendees will:

  • Learn to select the right suppliers that meet your quality needs
  • Examine how to implement risk assessment principles to improve your current supplier qualification program
  • Discover the top pitfalls: what can — and often does — go wrong

Peter Calcott, President, Calcott Consulting

2:45 p.m. – 3:30 p.m.

Selection, Qualification, and Monitoring of Third Party Logistics Providers (3PLs): Strengthening the Cold Chain
As the biotech industry continues to grow, and more and more temperature-sensitive drugs enter the market, the right 3PL can make or break your cold chain. This presentation focuses on choosing the right 3PL for the right products. Areas covered include: qualifying 3PLs, monitoring 3PLs, what to look for in temperature excursion investigations when they occur while your product is in the hands of a 3PL, methods for monitoring of 3PLs, and establishing quality agreements with 3PLs.

Attendees will:

  • Learn what elements to look for in finding the right 3PL for specific product needs
  • Learn the steps to take in qualifying a 3PL and review methods currently used for monitoring 3PLs
  • Review the quality elements that should be included in agreements between life sciences companies and 3PLs
Jim Darnell, Managing Consultant, Tunnell Consulting

3:30 p.m. – 3:45 p.m.

Networking and Refreshment Break

3:45p.m. – 5:00p.m.

Working With Suppliers: Dispel Industry Myths Panel Discussion

Moderator: John Avellanet, Managing Director, Principal Consultant, Cerulean Associates
Panelist: Alexa Smith, Chair of IPEC America's Quality Agreement Subcomittee, Manager, Global Regulatory Affairs, Colorcon
Panelist: Gerard Pearce, Rx360, Executive Vice President, SQA Services, Inc.
Panelist: John Hollenbach, President & CEO, Doe & Ingalls, Inc.
Panelist: Brant Zell, Vice President of Quality and EHS, Cherokee Pharmaceuticals LLC, Chairman of SOCMA's Bulk Pharmaceuticals Task Force, Member FDA Industry Coalition
Panelist: Henry Su, Senior Applications Compliance Specialist, BASF Corporation

5:00 p.m. – 6:30 p.m.

Adjournment and Networking Reception


8:00 a.m. – 8:45 a.m.

Continental Breakfast

8:45 a.m. – 9:00 a.m.

Welcome and Introduction by Chairman Jim Darnell, Managing Consultant, Tunnell Consulting

9:00 a.m. – 10:00 a.m.

International Perspective On Supply Chain Complexity
The growing number of API and excipient suppliers popping up in new locations around the world has reinforced the realities that more complex supply chains are proving to be potentially more fragile if not adequately supervised. This session will describe the expectations and experiences of an international regulatory authority from an inspector's perspective on supplier quality and the impact events that have begun to shape how authorities enforce compliance throughout the entire supply chain.

Mark Mansour, Partner, Bryan Cave LLP

10:00 a.m. – 11:00 a.m.

Strategies for Reducing Supply Chain Risk through Real-Time Visibility & Collaboration — A Case Study
Global manufacturers and brand owners who want to optimize and leverage the cost advantages of global supply networks, must also ensure product quality to protect their brands.
Attendees will learn:

  • The strategy and processes behind a transparent and proactive approach to supplier product quality
  • Benchmarks showing positive business results of embracing a transparent and proactive approach to supplier quality
  • How to turn FDA regulations into an impetus for proactive processes that enable higher product quality, growth and profitability

Al Alaverdi, Sr. Supply Chain Quality Solution Consultant, Camstar Systems, Inc.
Dave Busch, Sr. Supply Chain Consultant, SVTC

11:00 a.m. – 12:00 p.m.

Pharma and Device “Put Away the PowerPoint” Panel Discussion and Closing Comments
In this interactive panel discussion, there will be no PowerPoint presentations — just a review of the event’s highlights and what can we take away and put into practice upon our return. Our chairpersons, panelists and attendees will describe the idea or strategy they most found interesting and plan to bring back to their companies.

Moderator: Jim Darnell, Managing Consultant, Tunnell Consulting
Panelist: Dan O’Leary, President, Ombu Enterprises
Panelist: Tim Mohn, Industry Principal, Sparta Systems