SQMC 2012 Agenda

Pre-Conference Workshops: Tuesday, July 31, 2012

12:00 p.m. – 1:00 p.m.

Registration and Continental Breakfast

1:00 p.m. – 5:00 p.m.

Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation
The development of extended supply chains raises major issues in risk management. While regulators are looking more closely at device supplier management issues, companies are recognizing the value of risk management in meeting the regulatory requirements. In addition, risk management can help device manufacturers protect themselves against problems, develop more effective management systems, and control costs. You can start to prepare with important GHTF guidance documents: Control of Suppliers (GHTF/SG3/N17:2008), Control of Products and Services from Suppliers (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 supplier management process and the major steps involved
  • The issues of supplier risk management – product risk, business risk, and recalls & liability risk
  • How to conduct an on-site supplier audit applying risk management
  • How to qualify suppliers that are virtual companies
  • Understanding business issues in the supply chain and their risk challenges
  • Medical device corrections & removals (recalls)
  • How to select and apply supplier metrics and their role in the QMS
  • Dealing with FDA recordkeeping issues – sponsor vs. supplier

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. – 4:00 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:

  • 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, Partner, Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP
Lynn Scott, Partner, Corporate Practice Team, Arnall Golden Gregory LLP

DAY ONE: Wednesday, Aug. 1, 2012

8:00 a.m. – 9:00 a.m.

Registration

9:00 a.m. – 9:15 a.m.

Welcome and Introduction by Chairman

9:15 a.m. – 10:00 a.m.

Keynote: Securing the Pharmaceutical Supply Chain
Given the challenges and threats posed by an increasingly globalized marketplace, the FDA is working hard to modernize its approach to drug safety. The FDA is asking Cogress to grant it additional regulatory authority to achieve objectives such as:

  • Leveling the playing field — By being allowed to refuse product admission to the US if inspection of a foreign manufacturing facility is delayed, limited, or denied.
  • Increasing drug safety by granting the agency mandatory recall authority — While in most instances firms eventually agree to voluntarily recall drugs that the FDA believes pose a risk, the FDA lacks the authority to compel such recalls and critical time can be lost in negotiations between the FDA and a firm, leaving the public exposed to potentially serious health risks.
  • Increasing Information — One key area of concern is the modernization of drug registrations and listings.  Revising these statutory provisions may improve the timeliness, completeness, and accuracy of the FDA’s current registration and listing information, making sure the FDA has accurate and up-to-date information about foreign and domestic parties involved in medical product manufacture.

This presentation will provide attendees with the latest on these fronts and what the FDA hopes it will achieve through the reauthorization of PDUFA V and other measures under consideration.

10:00 a.m. – 10:45 a.m.

Singing the Chain Gang Blues — Managing Risk in the Supply Chain
The 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 product liability suits, yet sometimes suppliers fail to offer the level of transparency and quality control that medical device companies need. Using case studies and actual data on product problems, legal claims and monetary awards, this presentation will show you best practices for managing product liability risk in your own supply chain.

Attendees will learn about:

  • Who is legally responsible in a manufacturer-supplier relationship for a 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 product liability claims
  • Best practices to help manufacturers better manage liability risk in the supply chain

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 12:30 p.m.

Panel Discussion: Point/Counterpoint — Integrating the Management of Product Risk and Supplier Quality
The three classic parameters of risk management include; severity, likelihood of harm and dealing with mitigations that drive risk reduction. Add in the need to retain suppliers with special skills and expertise to provide essential components and ingredients and you have the potential for a quality "perfect storm." So the question is: Should these apparently independent activities — managed by different functions within an organization — be integrated? In this point/counterpoint debate four panelists will debate the integrated versus independent management methodology. Each side will present its case with the second speaker of each side addressing weaknesses of their opposition's position. This will be followed by the audience judging each side's arguments and providing their own personal experiences.

Attendees will learn:

  • Supply chain risks: How to consider BOTH component quality AND continuity of supply
  • Design and process management: Best practices for managing their contribution to risk management at both the home and supplier facilities
  • Understanding the importance of “trust but verify”
  • Who is ultimately responsible for quality problems?
  • Tips for including suppliers in risk management plans

12:30 p.m. – 1:30 p.m.

Lunch Break

Track 1 — Drug

1:30 p.m. – 2:15 a.m.

Qualification, Monitoring and Challenges in Working with International Suppliers
Supplier control issues will remain high on the list of the 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

2:15 p.m. – 3:00 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 look for red flags and solutions to keep contaminated APIs out of your products.

Attendees will learn:

  • 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

3:00 p.m. – 3:45 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 biologics 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

3:45 p.m. – 4:30 p.m.

Little Fish in a Big Pond: Creating Leverage with Your Supply Base
As a small- or mid-sized drug manufacturer, it can be challenging to get the desired attention from large suppliers.With increasing quality requirements on suppliers, it is critical to create leverage with your supply base. In lieu of the relatively low volume of business you might be offering your suppliers here are strategies to help increase your clout.

Attendees will learn:

  • How to select the right vendors for their business’ size and purchasing volume
  • Examine how to choose the right level of communication — to push your vendors and when to hold back
  • Best practices to walk away from non-performing vendor but still maintain good relations
  • Tips for evaluating the difficult price vs. cost of quality dilemma

4:30 p.m. – 4:45 p.m.

Refreshment Break

4:45 p.m. – 6:00 p.m.

Panel Discussion: Strengthening the Security Chain – How to Protect Your Product from Crooked Employees, Highway Pirates, Warehouse Warriors and Other Miscreants
Recently, federal authorities arrested 11 South Florida men in connection to multi-million dollar drug thefts at the warehouses of Eli Lilly in Connecticut, GlaxoSmithKline (GSK) in Virginia and others. The largest theft came from Lilly’s Enfield, Conn., facility, where in March 2010 members of the group cut a hole in the roof to enter the warehouse and disable the security system. They were also charged with the cargo theft of prescription drugs from a truck stop in Ohio and selling products stolen from a trailer at a Tennessee truck stop.

Attendees will learn:

  • How to educate truck drivers on hijack awareness, prevention, rapid reporting of incidents and good data gathering
  • Tips to remind drivers of corporate policies and emergency contact numbers should an emergency occur
  • Best practices for communications between drivers and corporate contacts while drivers are on the road and when stopped
  • The importance of reporting all cargo thefts to the FDA, EMA and/or appropriate regulatory agency

Track 2 — Device

1:30 p.m. – 2:15 p.m.

Got Bloated Supplier Lists? Applying Lean Principles to Supplier Assessment Criteria
As device companies grow, whether organically with new product and technology offerings, or via acquisitions, their Approved Supplier List (ASL) can become bloated and filled with redundant suppliers. Unless specifically and actively managed, especially during an acquisition, the criterion of what a “critical” supplier is becomes diluted. As a result, the ASL and the level or type of assessment for each supplier becomes confused and overwhelming. Without a clear, precise method to assess suppliers and define criteria for documenting their assessments, device companies put themselves at risk. This risk extends beyond strict compliance to impact on their yield, headcount, scrap and, therefore bottom line. By applying a lean method of determining who “critical” suppliers are based on commodities, it allows companies to focus their supplier assessment resources on the vital few.

Attendees will learn:

  • How to develop a risk-based set of criteria to categorize commodities
  • What’s the critical required documentation to support both business and compliance needs
  • Applying lean principles to continually re-assess the supply base, focusing on the riskiest commodities
  • Applying this criteria proactively during acquisitions

2:15 p.m. – 3:00 p.m.

Benchmark Other Industries that Use Technology to Collaborate and Monitor their Global Supply Chain
A Case Study with Siemens Enterasys Networks

Most Life Science companies have experienced a significant increase in the complexity and scope of their supply chain. But as costs go down (and hidden quality costs go up), control and oversight of product quality becomes more difficult. As sources of Product Quality Data become more dispersed and harder to access across the globe, the traditional methods of supplier monitoring become less effective and collaboration more difficult. While audits, score-carding, and incoming inspection are still important tactics in an overall supplier monitoring approach, they are reactive, not timely, incomplete, 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.

This session will describe examples of companies across different industries who have addressed Supply Chain Quality challenges with state-of-the-art technology solutions. Siemens Enterasys Networks will provide a detailed case study of how it is able to:

  • Accelerate new product introductions by rapidly identifying and reducing supplier variability
  • Employ methods to monitor component performance to detect unauthorized changes and counterfeit parts in the global supply network
  • Monitor and ensure product quality at contract manufacturers in Asia and Europe as part of its outsourcing strategy
  • Reduce costs of returns and repairs, warranty reserves, and the associated risks of recall

3:00 p.m. – 3:45 p.m.

Anatomy of a Partnership: How to Form Strategic OEM Supply Chain Alliances or Supplier Partnerships
In a perfect world, a device manufacturer would select a material supplier whose interests and systems align with the medical device industry and with the FDA’s compliance expectations. The device manufacturer’s commitment to the supplier wouldn’t rely solely on price but more on the shared investment each has made in the other. The partnership would achieve greater levels of control, ensure timely delivery and maximize regulatory compliance. In the longer term, this supply chain management approach would increase the speed of bringing successful products to market while also managing risk. If you think this is a pipedream, think again. This session will present ways to build partnerships you never thought possible.

Attendees will learn:

  • Attributes to look for in a customer or supplier that translate into partner potential
  • Best practices for developing the partnership – tips for avoiding the common start-up pains
  • How to care and feed the partnership so it can grow

3:45 p.m. – 4:30 p.m.

Are You Ready to Serve as the Supplier Gatekeeper? 10-Point Purchasing Controls Checklist for Device Manufacturers
As it appears that compliance with the FDA’s purchasing controls requirements has become, and continues to be, a greater enforcement priority for the FDA, it is very important for companies to shore up their purchasing control processes, particularly if a company’s suppliers reside outside of the US. This presentation will detail 10 important issues that device manufacturers need to know.

Attendees will learn:

  • How to explicitly establish initial qualification requirements
  • Why clearly defining the level of control to exercise over each supplier is important
  • Including processes for disqualification and re-qualification of suppliers
  • Balancing purchasing controls with receiving acceptance
  • Tying purchasing controls into a company’s CAPA system
  • Applying a company’s purchasing controls and incoming inspection policies to internal suppliers
  • Requiring that certain agreements include postmarket issues
  • Maintaining an approved supplier list
  • Requiring that contracts include provisions to notify process or product modifications
  • Training all personnel with purchasing or inspection responsibilities

4:30 p.m. – 4:45 p.m.

Refreshment Break

4:45 p.m. – 6:00 p.m.

UDI Rule Coming Soon — What Does It Mean For You?
The Office of Management and Budget (OMB) could release the FDA’s proposed rule on a unique device identification (UDI) system “any day now,” an agency official says, ending a nearly year-long delay in finalizing the much-anticipated safety mechanism. The UDI itself will have two components: the device identifier, which is analogous to a National Drug Code and differentiates between packaging; and the production identifier, which primarily uses serial numbers and lot numbers as control mechanisms. This panel will discuss:

  • What the FDA expects from device makers
  • Deadlines for implementation by product class
  • How to integrate UDI into your existing supply chain operations
  • Unexpected implications of UDI for small/mid-sized device companies

6:00 p.m. – 7:00 p.m.

Adjournment and Networking Cocktail Reception

DAY TWO: Thursday, Aug. 2, 2012

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:15 a.m.

Chair Welcome and Introduction

9:15 a.m. – 10:00 a.m.

Current FDA Inspection, Enforcement Trends, and Field Issues
CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative — which aims to create an ongoing culture of quality at medical device manufacturers. One important goal of the Case for Quality is that it seeks to encourage devicemakers to implement strong quality systems — based on industry best practices — rather than reactively waiting for deficiencies to be discovered during inspection. The FDA continues to see a “consistently high volume” of the same quality shortcomings year after year, and 2011 was a record year for inspections classified as “Official Action Indicated,” which denotes a severity of concern. The FDA is aggressively pursuing tighter controls for preapproval inspections, supplier quality management and cGMPs.

Attendees will learn:

  • How the FDA establishes inspectional priorities
  • Current agency, CDRH, and district inspection and enforcement
  • focus
  • Profile of recent warning letters and 483s
  • Supply chain issues
  • Other issues of present and growing concern

10:00 a.m. – 10:45 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.
  • 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

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 12:00 p.m.

CDER’s Expectations Regarding the Role/Accountability of Management for Supplier Oversight, Qualification and Monitoring
Because of industry’s appetite for outsourcing and sourcing materials from the lowest-cost provider, the FDA remains vigilant to minimize the risk of supplier quality problems. The number of offshore suppliers continues to climb — nearly tripling in recent years. China alone has nearly 1,000 makers of drug substances. Join this special presentation to improve your global supplier management and auditing practices.

Attendees will learn:

  • What is the FDA focusing on and how do they set their priorities?
  • How the FDA’s international offices are managed and their role in the supplier quality oversight process
  • Why management must make the commitment to properly qualify and monitor their suppliers

12:00 p.m.

Conference Adjourn