SQMC 2011 Agenda

Revised as of July 25, 2011

Pre-Conference Workshop: Tuesday, Aug. 9, 2011

12:00 p.m. – 1:00 p.m.

Registration and Continental Breakfast

1:00 p.m. – 5:00 p.m.

WORKSHOP A: Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation
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). These guidance documents provide the foundation, but lack 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.

Dan O’Leary, President, Ombu Enterprises
John Avellanet, Principal Consultant, Cerulean Associates (Co-chair)

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 read, “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 part.” In this workshop attendees will learn how create, and format quality agreements to show strengths in the documents and avoid the potential consequences of inadequate quality agreements.

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

Steven Sharf, President, GMP Concepts (Co-chair)
William Reiss, Senior Manager, Supplier QA Agreements & Global Sample Retention, Celgene

DAY ONE: Wednesday, Aug. 10, 2011

8:00 a.m. – 9:00 a.m.


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. – 10:00 a.m.

Opening Keynote: Supplier Controls — The Latest FDA Medical Device Requirements
The FDA has been actively focusing on the protection and integrity of supply chain for medical devices. Understanding the FDA’s approach is essential to ensuring compliance and avoiding inspection issues. In this session Ms. Trautman will take you through the latest FDA policies and processes.

Attendees will learn:

  • What common supplier issues does the FDA uncover in medical device inspections and how can firms avoid them
  • What should suppliers, contractors and consultants have to meet the requirements established by the finished device manufacturer
  • After the initial assessment or evaluation, what should be the combination of assessment methods, and how to include third-party or product certification

Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA

10:00 a.m. – 10:45 a.m.

The GHTF Document on Supplier Controls
In 2009, the FDA´s highest QS Subsystem identified in Warning Letters to Manufacturers and 2nd highest 483 Observation was "Production and Process Controls." The FDA has shown concerns with the robustness of the manufacturing controls, which will only come under further scrutiny as more OEMs outsource their manufacturing of finished medical devices. The Global Harmonization Task Force (GHTF) SG3 published a great guidance document that outlines Supplier Controls. This presentation will review the current Guidance documents provided by the GHTF and the FDA, and identify some best practices that can be easily implemented that can used to improve your new and existing processes.

Kimberly Trautman, Medical Device Quality Systems/GMP Expert, Office of Compliance, CDRH, FDA

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 12:30 p.m.

Panel Discussion: Supplier Quality Agreements – Five Lessons Learned and Five Mistakes to Avoid
Trying to match regulatory requirements, business expectations, legal recommendations and best practice guidelines can be fraught with hidden pitfalls and expensive mistakes. What are some of the surprises that pharma and device executives have had to deal with when negotiating – and enforcing – supplier quality agreements? What advice can seasoned supplier management professionals impart to avoid the hidden pitfalls in supplier agreements? How can pharma and device firms take advantage of the experiences of their suppliers without being run-over and left vulnerable? Take this opportunity to get the opinions of this expert panel and ask them questions as they discuss the challenges associated with supplier quality agreements.

Panelist: Hidee Molina, Division of Manufacturing and Product Quality, CBER, FDA
Panelist: Alan Minsk, Partner, Arnall Golden Gregory LLP
Panelist: Steven Sharf, President,GMP Concepts
Panelist: Mike Weber, Director of Quality, Soluble Systems
Panelist: William Reiss, Senior Quality Agreements and Sample Retention, Celgene
Moderator: John Avellanet, Managing Director, Cerulean Associates

12:30 p.m. – 1:30 p.m.

Lunch Break

Track 1 — Drug

1:30 p.m. – 2:15 a.m.

Lessons Learned from Recent Recalls and Defective Product Cases
Recent case studies dealing with the topics of recalls, poor risk management, and defective products have resulted in negative public health outcomes due to manufacturers not having adequate supplier quality procedures. Following a risk-based supplier quality program improves quality of the products being manufactured, reduces risk and minimizes liability. Widespread recalls have unnecessarily resulted in loss of confidence in the regulated industry and FDA.

This presentation offers an opportunity to hear an expert analysis of recent cases and how you can learn from the mistakes of others.

Steven Niedelman, Lead Quality System & Compliance Consultant, King & Spalding LLP

2:15 p.m. – 3:00 p.m.

Writing A Robust Audit Observation That Suppliers Can Actually Understand and Use
Supplier issues with audit observations during an audit closeout meeting are essential for ensuring requirements are met and safe products are produced. However, a supplier cannot fix problems they do not understand. This presentation will discuss how to write a robust observation…the kind that has substance, is based in regulation, and most importantly, the kind that is actionable by the auditee.

Attendees will learn:

  • What constitutes a robust observation that an auditee can understand and take action from
  • Real examples of good observations and poor observations
  • An understanding of how to record actionable observations

Steven Sharf, President, GMP Concepts

3:00 p.m. – 3:45 p.m.

Real-Time Risk Profiles of GMP Material Suppliers — An Essential Supplier Quality Risk Management Tool
Risk assessment tools are commonly used in reaction to supplier quality events. Quality risks and impact posed by suppliers is documented, approved and filed. This information may become outdated as soon as it is documented. It is important to maintain a real time risk profile for material suppliers. This presentation describes the importance and an example of continuously monitoring supplier quality risk from the point of supplier selection through to disqualification.

Attendees will learn:

  • One industry case study of how to evaluate material supply channel risk
  • How to incorporate Quality Risk Management principles into the Supplier Quality Management Lifecycle
  • Events that should trigger re-evaluation of supplier quality risk levels in order to maintain a real-time risk profile for each material supplier

Londa Ritchey, Director, Supplier Qualification, Pfizer

Track 2 — Device

1:30 p.m. – 2:15 p.m.

Do’s and Don’ts for Implementing Effective Quality Agreements
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 learn:

  • 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

Alan Minsk, Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP

2:15 p.m. – 3:00 p.m.

Auditing Your Entire Supplier Base Once A Year — Benchmarks for Success
Audits are one of the best ways to ensure that a supplier is following the processes and procedures agreed upon. More than 50% of the manufacturers do not follow audit best practices while engaging with their suppliers. By implementing benchmarks, manufacturers ensure that the audit process is effective and efficient and allows them to audit their entire supplier base at least once a year.

Attendees will learn:

  • Criteria for an effective due diligence program to begin with high quality vendors
  • Key contract provisions that support quick, efficient auditing of suppliers
  • How to employ risk management principles to determine which order to audit vendors
  • Risks of contracting with facilities that have never registered with the FDA

Anthony Pavel, Partner, K&L Gates

3:00 p.m. – 3:45 p.m.

Supplier Management and the FDA
FDA has increased their attention and enforcement over purchasing and supplier controls. There has been a steady increase of 483s and Warning Letters noting deficiencies with purchasing controls in both the medical device and pharmaceutical industries. As a result, it has become even more essential to have a robust and efficient supplier management program established.

Attendees will learn:

  • What makes supplier management within a regulated industry unique
  • The basic requirements for an effective process
  • Methods of risk-based supplier classification
  • Best practices for communicating quality expectations

Susan Reilly, President, Reilly and Associates

3:45 p.m. – 4:00 p.m.

Refreshment Break

4:00 p.m. – 5:30 p.m.

Panel Discussion: Working with Suppliers — Dispelling Industry Myths
What are some of the biggest challenges suppliers face during their audits? What are some of the hurdles that pharma faces when trying to get across the importance of compliance? What are the real differences in regulations for device manufacturers vs. those for raw material suppliers? Take this opportunity to get the opinions of this expert panel and ask them questions as they discuss these and other topics.

Panelist: William Reiss, Senior Quality Agreements and Sample Retention, Celgene
Panelist: John Avellanet, Managing Director & Principal Consultant, Cerulean Associates LLC
Panelist: Debra Manning, Vice President for Quality & Regulatory Affairs, Coeur Inc.
Panelist: Henry Su, Sr. Product Regulations Specialist, BASF
Moderator/Panelist: Steven Sharf, President, GMP Concepts

5:30 p.m. – 6:30 p.m.

Adjournment and Networking Cocktail Reception

DAY TWO: Thursday, Aug. 11, 2011

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:05 a.m.

Chair Welcome and Introduction

9:05 a.m. – 9:45 a.m.

Import Holds and Update in the FDA’s PREDICT System
The Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, which reviews FDA-regulated products offered for import, enables inspectors to determine which imports should be reviewed further by looking at the company and country of origin, type of product, and compliance history of recipient, among other criteria. The system is expected to speed up the release of acceptable products and allow the FDA to focus on riskier products that require further investigation.

Attendees will learn:

  • How the PREDICT system will influence the import alert and hold process
  • Best practices to assure your PREDICT profile doesn’t raise red flags with the FDA
  • The levels of import holds, and the likelihood of a successful challenge at each 6 techniques for communicating with FDA personnel — slow communication and miscommunications are lethal when the clock is running on your shipments
  • How to understand and comply with documentation requirements — not having your paperwork in order is a surefire way to have your import held
  • The levels of import holds and the likelihood of a successful challenge at each

Benjamin England, Esq., Founder, FDA Imports

9:45 a.m. – 10:25 a.m.

Qualification, Monitoring and Challenges in Working with International Suppliers
Supplier control issues will remain high on the list of FDA’s targets for inspection and enforcement activity this year. Unique issues in supplier management include the diversity of supplied products and services, the varying complexity of obtaining materials and components from international suppliers, and the wide range of risk from different products – even from different products provided by the same supplier to the same customer.

This presentation will discuss some common challenges in working with international suppliers and best practices for overcoming these challenges.

Attendees will learn:

  • The challenges faced by the pharma industry in dealing with suppliers from within the EU vs. the US and the rest of the world
  • Understanding the diversity of rules and regulations associated with supply, especially from within the EU and in meeting QP (Qualified Person) requirements
  • The wide range of risk from different products around the world supplied by the same supplier and how to overcome and mitigate these risks
  • The EU GMP guidelines in relation to supplier quality – how these must be applied and considered when working with international suppliers
  • Ways to approach qualifying and then monitoring your supplier, ensuring compliance with EU guidelines

Elaine Dymond, Vice President of Quality, Catelent Pharma

10:25 a.m. – 10:35 a.m.

Refreshment Break

10:35 a.m. – 11:15 a.m.

Trust But Verify: A Look At How Other Industries Use Technology to Monitor Supplier Quality In Real Time
Traditional methods of supplier monitoring rely on audits, AQL sampling at Incoming Inspection, review of certificates and periodic scorecarding. While all of these are important tactics in an overall supplier monitoring approach, they are reactive, not timely, and do not truly characterize the health of your suppliers' product quality. Best case, a quality issue detected at incoming will cause a minor supply chain disruption. Worse case, a quality issue will escape into manufacturing, or even into the field, which can result in a recall.

In this session you will learn how leading brand owners across different industries are using state-of-the art technology to monitor and collaborate with globally dispersed sites, suppliers and contract manufacturers to improve product quality and reliability. You'll hear how these companies are solving real challenges such as ensuring product quality at contract manufacturers in Asia, detecting unauthorized supplier changes, reducing supplier variability in a new product launch, detecting a counterfeit operation, and many others.

Jason Spiegler, Director, Business Development, Camstar Systems, Inc.

11:15 a.m. – 11:55 a.m.

Managing Risk in the Supply Chain
FDA’s Quality System Regulation and GHTF guidance require manufacturers to maintain strong supplier oversight and purchasing controls not only for regulatory compliance but also as part of their liability risk management strategy. Supply chain issues are a common source of costly field actions, adverse publicity and products liability suits, yet sometimes suppliers fail to offer the level of transparency and quality control that suppliers need. Using case studies and actual data on product problems, legal claims and monetary awards, this presentation will show you best practices for managing products liability risk in your own supply chain.

Attendees will learn:

  • Who is legally responsible in a manufacturer-supplier relationship for product's liability
  • How product liability affects the life sciences field
  • Where vulnerabilities lie in the manufacturer-supplier relationship
  • Early warning signs of impending supplier problems
  • The nature and volume of medical device products liability claims related to supplier issues
  • Best practices to help manufacturers better manage liability risk in the supply chain

Sara Dyson Esq., Loss Control Manager, Medmarc Insurance Group

12:00 p.m.

Conference Adjourn