InspectionSummit2010Agenda

Untitled Document

DAY ONE

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 9:15 a.m.

Opening Comments
Barbara Immel, President, Immel Resources LLC (Chairperson)

9:15 a.m. – 10:00 a.m.

Understanding FDA’s Findings and Warnings…and Steps to Preclude them from Happening
The FDA has indicated it will consistently enforce the FD&C Act to re-establish the public’s confidence in FDA and the industries it regulates. To stay compliant industry must understand the significance of inspectional outcomes, and the various tools available to FDA to effect compliance. The most effective tool of all is sustainable compliance within your firm to assure conformance to all regulations and statutory requirements. During this session you will develop a better understanding of inspectional outcomes, tools FDA has at its disposal to deal with them and steps industry can take to address them or preclude them from ever occurring. We will discuss:

  • Significance of FDA-483’s
  • Importance of daily inspectional updates
  • Timeliness and importance of effective FDA 483 responses
  • Meetings with FDA
  • Next steps FDA may take and how to deal with them
  • How to prepare for your next inspection
  • How to ensure conformance and compliance to FDA’s requirements
Steven M. Niedelman, Senior Consultant, Crowell & Moring LLP; former Deputy Associate Commissioner for Regulatory Operations, Chief Operating Officer and former Director, Office of Enforcement, FDA

10:00 a.m. – 11:00 a.m.

FDA’s Focus on Enforcement and Compliance
The traditional tools of a regulatory agency are regulation, approval or disapproval of applications, and enforcement. Globalization intensifies all the challenges the agency faces. To anticipate the next import crisis like that involving contaminated heparin, the agency should assess imported products for their potential to cause significant problems. In this presentation, Mr. Blumberg will discuss the agency's position on enforcement and compliance in support of achieving the overriding purpose of the agency — protecting the public health.

Eric M. Blumberg, Deputy Chief Counsel for Litigation in the Office of the Chief Counsel, FDA

11:00 a.m. – 11:15 a.m.

Refreshment Break

11:15 a.m. – 5:15 p.m.

Three Concurrent Breakout Tracks

  • Track 1 — Drug & Biologics Track
  • Track 2 — Medical Device Track
  • Track 3 — Clinical Trials Track

5:15 p.m. – 6:15 p.m.

Networking Reception

Drug & Biologics Track

11:15 a.m. – 11:30 a.m.

Moderator Comments
Vicky C. Stoakes,
President, IntegRx, Inc.; former FDA Investigator

11:30 a.m.–12:15 p.m.

Drug Safety and Integrity: Corporate Responsibility in an Era of Globalization
In today's global economy, industry and regulators are faced with numerous challenges in ensuring drug safety and integrity. Industry must be vigilant about recognizing and addressing these challenges. As always, inspections and enforcement activities are also key elements to ensuring drug safety and integrity. You'll learn:

  • Learn the importance of corporate responsibility in ensuring drug safety and integrity
  • Discover CDER's key areas of focus relating to inspections and enforcement

Deborah Autor, Director, Office of Compliance, CDER, FDA

12:15 p.m. – 1:00 p.m.

FDA Inspections of Virtual Companies: Requirements and Expectations of Outsourcing
This presentation outlines what to expect if the FDA inspects a company that outsources most or all of its governed activities. This session will detail GMP, GCP and GLP considerations. You'll learn:

  • What areas FDA might cover in an inspection of a virtual company — requirements and expectations for vendor management by outsourced companies
  • FDA proposals to strengthen the GMP regulations for supply chain

David Chesney, Vice President of Strategic Compliance Services, PARAEXEL Consulting; former FDA District Director for the San Francisco office

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

Logistics: Streamlining the Inspection Hosting Process
The mantra of “first impressions are lasting impressions” applies to regulatory inspections. Yet, in a regulatory inspection setting, a “great first impression” must last throughout the audit. You'll learn to:

  • Organize and prepare your subject matter experts to face tough questions
  • Manage an auditor’s request in a timely and accurate manner

John Giantsidis, Senior Manager, QA Compliance, AMAG Pharmaceuticals, Inc.

2:45 p.m. – 3:30 p.m.

Proven Best Practices for Responding to Form 483s
This session will discuss the most critical factors in the response process, including how to manage your response within the 15 days that the FDA suggests responses are due. You'll learn:

  • What to include and not include in the written response
  • The key steps for effectively responding to a Form 483
John Godshalk, Senior Consultant, Biologics Consulting Group; former FDA Inspector in the Division of Manufacturing and Product Quality at CBER, FDA

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 4:30 p.m.

CBER Inspectional Findings: A Review of Recent Warning Letters
CBER conducts inspections in support of marketing applications, to investigate complaints, and for surveillance of actively enrolling Phase I and II studies. This presentation will answer frequently asked questions about how CBER plans inspections and how they are conducted. You'll learn:

  • Answers to common questions about FDA GCP inspections
  • How CBER selects sites for inspection
  • Data trends from recent inspections

Mary Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA

4:30 p.m. – 5:15 p.m.

War Stories: Life on the Front Lines
Those who fail to learn from the mistakes of others are destined to repeat them. Real situations encountered by pharmaceutical companies will be used to help you understand FDA expectations and improve your regulatory compliance strategies. You'll learn:

  • How to avoid common problems and create a culture of quality within your organization
  • How to approach compliance issues from an FDA perspective

Vicky C. Stoakes, President, IntegRx, Inc.; former FDA Investigator

5:15 p.m. – 6:15 p.m.

Networking Reception

 Medical Device Track

11:15 a.m. – 11:30 a.m.

Moderator Comments
KR Karu, Director of Sales, Sparta Systems, Inc.

11:30 a.m. – 12:15 p.m.

An FDA Investigator’s Perspective in Assuring a Firm's Top Seven Subsystems are in Compliance and Linked Together
The Quality Systems Inspection Technique (QSIT) approach to inspections was derived from the theory that there are seven subsystems in the quality system regulation — four primary areas were chosen to focus the inspection. The four top subsystems are: management controls, design controls, corrective and preventive actions, and production and process controls. You'll learn:

  • What elements of QSIT the FDA focuses on and why
  • How QSIT violations typically appear in 483s and warning letters

Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District

12:15 p.m. – 1:00 p.m.

Lessons Learned: How Product Failures, Recalls and GMP/QSR Problems Trigger FDA Enforcement Actions
FDA administrative and judicial enforcement actions have increased in the past few years. Many companies and corporate officials fail to heed important warning signs of impending trouble and are surprised when FDA takes enforcement action. This session will share important lessons learned from actual case studies. You'll learn:

  • The early warning signs of problems in products and quality systems
  • What key actions should be taken to contain problems and avoid enforcement
Mark Brown, Partner, King & Spalding, former Associate Chief Counsel, FDA

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

FDA's Focus on the Regulation of Device Software
More medical devices than ever have software integrated in their systems. Even some stand-alone software packages are considered medical devices. The numbers of both are certain to increase, making software a focus of FDA and other regulators. This presentation will explain how to determine if your software is a regulated product and tell whether or not your software product will require a pre-market submission. You'll learn:

  • What the FDA is looking for in compliant medical device software
  • How to assess the level of concern of a regulated software product

Nancy Isaac, Vice President of Regulatory Affairs and Quality, Broncus Technologies

2:45 p.m. – 3:30 p.m.

The FDA’s Foreign Medical Device Inspection Program
The FDA is increasing its scrutiny of medical devices that are manufactured outside of the U.S. This attention is prompted by an increase in foreign manufacturing capacity and concerns regarding the safety of imported devices. There are important differences between European and ISO audits and FDA inspections, as well as between foreign and domestic FDA inspections. You'll learn:

  • The differences in the regulation of domestic and foreign manufacturers under the FDCA and the consequences of those differences
  • The most frequent mistakes as reflected by the top observations noted in warning letters issued to foreign medical device manufacturers

Seth Mailhot, Counsel, Nixon Peabody LLP; former Compliance Officer and Medical Device Investigator, New England District Office, FDA

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 4:30 p.m.

CDRH’s Compliance and Enforcement Outlook
This presentation will focus on CDRH’s inspectional priorities for the coming year and how the center approaches the inspectional process. Attendees will learn how they can more proactively prepare for FDA investigators before they arrive. You'll learn:

  • 7 tips for better post-inspection correspondence
  • When should you ask for a post-inspection meeting

Larry Spears, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA

4:30 p.m. – 5:15 p.m.

Managing Outsourced Operations for Device Manufacturers: Reducing Risk and Improving Quality
It’s an ironclad FDA rule that when you outsource any regulated part of your device manufacturing operation, you’re still responsible for the quality and conduct of the suppliers. It simply doesn’t matter if they are around the block or around the world — if you engage them, you’re liable for them. You'll learn:

  • The importance of developing a risk-based supplier quality program
  • Different ways to assess suppliers based upon risk
Monica Wilkins, Senior Director, Corporate Quality Assurance and Compliance, Abbott Laboratories; former Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator

5:15 p.m. – 6:15 p.m.

Networking Reception

Clinical Trials Track

11:15 a.m. – 11:30 a.m.

Moderator Comments
Cecilia Matos-Rosa, Sr. QA Auditor — GCP, AMAG Pharmaceuticals, Inc.

11:30 a.m.–12:15 p.m.

The Most Common Findings in Clinical Trial Inspections — An FDA Perspective
This session will provide a brief overview of the FDA’s clinical investigator inspection program and a summary of the inspectional process. You'll hear the most common findings and possible outcomes of FDA regulatory inspections of drug, device and biologic clinical investigator sites. You'll learn:

  • Gain an in-depth overview of the FDA inspectional process of clinical sites
  • Tips to prepare for an FDA inspection

Stephanie Shapley, Bioresearch Monitoring Specialist, Office of Regulatory Affairs, FDA

12:15 p.m. – 1:00 p.m.

Clinical Data Falsification: A Four Letter Word
Sponsors should be prepared to shoulder more responsibility in finding and reporting investigator misconduct as the FDA cracks down on falsified data in clinical trials. What should be the next steps if a sponsor learns about problems at a site? You'll learn:

  • What and when to report to the FDA
  • Current standards and implications of FDA's proposed rule

David Clissold, Director, Hyman, Phelps & McNamara

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

Conducting Compliant GCP Audits: A Sponsors Perspective
The FDA has made it clear that sponsors are responsible for managing risk at each stage of the drug or biologic life cycle. This session will focus on maintaining compliant GCP studies from a sponsor’s perspective. You'll learn:

  • Best practices used in compliant HCP audits
  • How to effectively work with a site during the clinical study

Deborah Waltz, Senior Director, Scientific Operations Quality, King Pharmaceuticals

2:45 p.m. – 3:30 p.m.

Inspector's Preparation for a Clinical Inspection — The Protocol and the Science
A clinical trial can be viewed as a series of key activities. The WHO Handbook for GCP identifies 15 key activities in conducting a single clinical study. While the order of these activities may vary and some of the activities may be completed simultaneously, each is important from a regulatory viewpoint. You'll learn:

  • Why a site is chosen for inspection
  • How investigators prepare themselves on the investigational product and the disease under study

David A. Lepay, Senior Advisor for Clinical Science, Good Clinical Practice Program, FDA (invited)

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 4:30 p.m.

Harmonizing Regulatory Approaches to Clinical Trials to Improve Quality and Compliance
The FDA is continually searching for methods to improve the quality of clinical trials while maintaining compliance. In this presentation, Dr. Ball will discuss efforts to harmonize clinical trial regulations to improve quality and compliance. You'll learn:

  • FDA’s efforts to work with international regulatory bodies on harmonization
  • How the focus on quality improves compliance throughout the clinical trial process

Ann Meeker-O'Connell, Division of Scientific Investigations, Office of Compliance, CDER, FDA

4:30 p.m. – 5:15 p.m.

Build Quality into Device Clinical Trials to Ensure Compliance  and Pass FDA Inspections
This session will discuss the FDA’s Center for Devices and Radiological Health (CDRH) inspection process for device studies. He gives suggestions for planning and conducting a quality clinical trial, and ideas for analyzing and working through problems in ongoing studies. You'll learn:

  • Common sponsor and investigator deficiencies and compliance rates
  • The habits of highly successful sponsors

Michael Marcarelli, Director of Bioresearch Monitoring, CDRH, FDA

5:15 p.m. – 6:15 p.m.

Networking Reception

DAY TWO

8:30 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:15 a.m.

Opening Comments
Barbara Immel, President, Immel Resources LLC (Chairperson)

9:15 a.m. – 10:00 a.m.

Inspections Beyond US Borders — Inside the ORA's International Operations Branch
The FDA's Office of Regulatory Affairs, through its Division of Field Investigations, provides coordination, direction, assistance and management for the field's domestic and foreign investigative activities. The International Operations Branch (IOB) develops and reviews investigative and inspectional procedures and training programs, and prepares and issues investigative and inspectional guidance manuals. You'll learn:

  • How the IOB deploys its resources to manage international inspections
  • Current inspectional trends the FDA sees at foreign facilities

Rebecca Ramos Hackett, Director of International Operations Branch, FDA (invited)

10:00 a.m. – 10:45 a.m.

Change Control: Current Best Practices for FDA-Compliant Systems
Inadequate change control procedures can create a huge noncompliance risk. The FDA has issued numerous warning letters citing just that problem. Change control, the most critical element in a pharmaceutical or biotech company's quality management system, continues to be one of the most difficult systems to manage. You'll learn:

  • What FDA inspectors are trained to look for in change control systems, requests and follow-up
  • How to manage and implement effective change control

Barbara Immel, President, Immel Resources LLC (Chairperson)

10:45 a.m. – 11:00 a.m.

Refreshment Break

11:00 a.m. – 11:45 p.m.

“Put Away the PowerPoint” Panel Discussion — What Keeps You Up At Night? Examining the Top 5 Inspectional Concerns of Drug and Device Professionals
In this interactive panel discussion, there will be no PowerPoint presentations — just a frank discussion and exchange of ideas! No one person has the right answer to the vexing problems of drug and biologic inspectional readiness. Prior to the Summit, we’ll survey you and your colleagues to determine the top 5 problems you’re facing.

Moderator: Barbara Immel, President, Immel Resources LLC (Chairperson)
Panelist: Rebecca Ramos Hackett, Director of International Operations Branch, FDA
Panelist: Dan O’Leary, President, Ombu Enterprises
Panelist: Janice B. Wilson, Vice President, Quality Operations, Elan Pharmaceuticals, PLC

11:45 a.m. – 12:00 p.m.

Closing Comments
Barbara Immel, President, Immel Resources LLC (Chairperson)

12:00 p.m.

Conference Adjournment