Sixth Annual FDA Inspections Summit

Revised as of Sept. 6, 2011

PRE-CONFERENCE WORKSHOPS – Tuesday, Oct. 4

12:00 p.m. – 1:00 p.m.

Registration

1:00 p.m. – 4:00 p.m.

Drug/Biologic Pre-Conference Workshop: Proven Model Procedures for Preparing for Drug and Biologic FDA Inspections: From Introductions to What Not to Say
This session will provide model procedures to handle nearly every aspect of a standard inspection, including introductions, phone trees, escorts, documentation, photographs and tapings. Plus, when to provide records access and when not to. When to say no and how to say no to an FDA inspector may be the most important things you will learn during this half-day seminar.

Attendees will learn:

  • Inspection basics
  • Developing inspection procedures
  • Tips for handling a difficult inspector
  • Using internal audits
  • Following up after an FDA inspection
  • What to do if you receive a 483 at the end of an inspection
  • Responding to inspectional observations
  • The closeout meeting with management

**Special Interactive Exercise: Mock Inspectional Situations**

Frederick Branding, Principal, Olsson Frank & Weeda
Cathy Burgess, Partner, Alston & Bird LLP

1:00 p.m. – 4:00 p.m.

Medical Device Pre-Conference Workshop: Back to the Drawing Board: Overhauling Your Complaint Compliance System
The workshop provides a comprehensive and unified approach to complaint management under the FDA device regulations. The workshop covers both FDA QSR and ISO 13485 QMS requirements for complaints. On the FDA side we use the Quality System Inspections Technique (QSIT) to illustrate the requirements and warning letters to help learn from the mistakes of others. We show the linkage between complaints and risk management in an ISO 14971 System. Because complaints lead to adverse event reports, the workshop reviews MDRs in the US and the EU Vigilance system. We also look at the role of clinical evaluation in the MDD and its relationship to risk management.

Attendees will learn the answers to these questions:

  • Do you know the definition of a complaint and how it differs between QSR and ISO 13485? The definition is probably not what you think.
  • Do you know how to integrate servicing into your complaint system?
  • What complaints does the manufacturer need to evaluate?
  • When should a manufacturer investigate complaints using the corrective action system?
  • When to report a complaint as an MDR to FDA. (Part 803)
  • When should you report a complaint as a vigilance report in the EU? (MEDDEV 2.12/1)
  • How do complaints relate to corrections and removals? (Part 806)
  • How can you relate risk management post-production information with MDD clinical evaluation?

Dan O’Leary, President, Ombu Enterprises

1:00 p.m. – 4:00 p.m.

Clinical Trials Pre-Conference Workshop: Beyond Pregnant Males: Understanding and Achieving Quality in Clinical Research Data
High-quality data is essential in clinical research, and companies spend an enormous amount of time and resources to achieve it. Most efforts are focused on source data verification and edit checks, but these only catch errors after the fact and do not build quality into the process. This course defines quality in clinical data, describes how to optimize it by using risk management to focus on important data, and outlines emerging regulatory requirements for formal quality management systems in clinical trials.

Attendees will:

  • Define quality in clinical research data
  • Identify key factors that affect data quality
  • Identify and prioritize all study team data quality requirements
  • Apply risk management to optimize data quality efforts
  • Define quality management systems and sites, monitors and data managers

Kit Howard, Clinical Data Management, Standards and Quality Consultant, Kestrel Consultants

Plenary and Tracks – DAY ONE – Wednesday, Oct. 5

8:00 a.m. – 8:45 a.m.

Registration and Continental Breakfast

8:45 a.m. – 9:00 a.m.

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

9:00 a.m. – 10:00 a.m.

4,000 Employees Strong — What Are ORA’s Goals for 2011-2012?
FDA’s Office of Regulatory Affairs is responsible for imports, inspections, and enforcement policy. So as 2011 nears a close and 2012 is on the horizon, what is it focusing on? Some would say, scrutinizing companies that have a track record of noncompliance with GMP and conducting additional inspections. Others have suggested placing investigators overseas to address the influx of foreign-sourced materials and finished products. ORA itself has said it wants to develop a cadre of specially-trained professional inspectors to focus on high-level drug and device inspections. Stay tuned for this insightful presentation on the goals for ORA in 2011-2012.

Attendees will learn:

  • What programs ORA is focusing on for the remainder of 2011 and 2012
  • Insights on how ORA’s risk-based approach helps “good” companies and puts “bad” firms on its radar

Roberta Wagner, Deputy Associate Commissioner for Field Operations, ORA, FDA

10:00 a.m. – 11:00 a.m.

From Washington to White Oak — What Is Congress Looking for the FDA and Industry to Accomplish Over the Next Year?
Lobbyists for the drug industry expect Congress to make quick work of authorizing the Prescription Drug User Fee Act (PDUFA) next year and make few changes to the package that industry and the FDA have negotiated. However, there are several wildcard factors that could slow the speed of the bill’s passage, including add-ons to PDUFA that lawmakers may choose to pursue in the important election year. Such add-ons could address import safety, drug shortages, rare pediatric disease vouchers and provisions, antibiotic incentives and biosimilars. Could this seemingly tidy bill turn into a “Christmas tree” by December? Hear directly from a senior Senate staffer on the latest developments and what you can expect in 2012.

Attendees will learn:

  • The current state of the FDA’s and industry’s agreement and how is it being perceived in Congress
  • How public hearings — scheduled for October — may change the agreement or add additional conditions

Keith Flanagan, Minority Health Counsel, U.S. Senate HELP Committee (invited)

11:00 a.m. – 11:20 a.m.

Refreshment Break

11:20 a.m. – 5:00 p.m.

Three Concurrent Breakout Tracks

  • Track 1 — Drugs & Biologics
  • Track 2 — Medical Devices
  • Track 3 — Clinical Trials

5:00 p.m. – 6:30 p.m.

Networking Reception

Drug & Biologics Track

11:20 a.m. – 11:30 a.m.

Moderator Comments — Frederick Branding, Principal, Olsson Frank & Weeda

11:30 a.m. – 12:15 p.m.

Understanding the Latest on the FDA’s Enforcement Position
This presentation will focus on ORA’s Office of Enforcement priorities for the coming year and how the office approaches the enforcement process. Armando Zamora, Acting Director, Office of Enforcement, ORA — will educate attendees on how they can more proactively prepare for FDA investigators before they arrive.

Attendees will learn:

  • The FDA’s position on recalls and the possible actions the Office of Enforcement can take in the wake of them
  • Effectiveness of criminal sanctions in improving compliance among drug and device company senior management
  • Whether 483s and warning letters will be produced more quickly and highlighted for the public as a deterrent to poor corporate behavior

Armando Zamora, Acting Director, Office of Enforcement, ORA, FDA

12:15 p.m. – 1:00 p.m.

The FDA’s Newest Stomping Grounds: Auditing API, Excipient and Other Contract Suppliers
Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin “seems inevitable.” All together, the number of offshore suppliers has nearly tripled in recent years. China alone has nearly 1,000 makers of drug substances and only a small percentage of inspections. Join the FDA’s former international guru for this special presentation to improve your global supplier management and auditing practices.

Attendees will learn:

  • Best practices for managing suppliers — be they next door or around the globe
  • How to structure supplier quality contracts to assure you’re receiving materials that are within specification
  • Ways in which shady suppliers like to pass off defective products to unsuspecting drug and device companies

Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding; former Deputy Associate Commissioner for Regulatory Operations, Chief Operating Officer and former Director, Office of Enforcement, ORA FDA

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

20 Ideas for Managing CAPA and the Inspectional Process
Learning from your colleagues their keys to successfully managing CAPA systems is worth the price of admission. Managing the corrective and preventive action process is one of the most difficult processes a drug or biologics company faces. For many years, CAPA violations have been at the top of list of 483 and warning letter violations. Why, after so much work in the area do drug and biologics firms still get it wrong? In this “take-away” driven presentation, attendees will go home with 20 time-tested ideas for better managing their CAPA programs.

Attendees will learn:

  • How reviewing 483s and warning letters helps determine what aspects of a CAPA program the FDA focuses on
  • 20 ideas that can make the difference between a good and a great CAPA program

Dianne Gobin, Associate Director, Program Management Office, MannKind

2:45 p.m. – 3:30 p.m.

Warning Letter Recovery Strategies — What to Do When You’ve Been Hit with Repeat Violations?
Recently the FDA has been cracking down on repeat offenders and offering up tough talk within 483 and warning letters. Firms dinged for multiple and repeat violations at the same facilities are deemed high risk and will face years of FDA scrutiny. If you’ve been cited for multiple or repeated violations it’s time to employ a warning letter recovery strategy. But where to begin? Drawing on decades of experience, this presentation will provide a roadmap to recovery.

Attendees will learn:

  • How to convert your root cause analysis investigations into actionable operational compliance strategies
  • Best practices for interacting with the FDA after the agency has placed you in a high-risk status
  • Tips for managing staff that must work under consent decrees and third-party auditors

Marie McDonald, Senior Director, Quality & Compliance Consulting, Quintiles

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 5:00 p.m.

Panel Discussion: The 10 Best — and 10 Worse — Things to Do When FDA Staff Are on Site to Conduct an Inspection
The behavior of drug company staff during an inspection runs from supremely professional to downright comical. There are the stories of crack teams of QA/RA professionals who have every document and every answer an investigator needs, and then there are stories of firms that foolishly refuse to let the investigator into the plant. This panel takes the best and worst of the industry’s performance and combines it into one great lesson for you and your staff. This year’s panelist have seen it all and are here to give you the “skinny” on how to pass your upcoming inspection with flying colors.

Panelists include:

  • Heather Neill, Director of Clinical Affairs, ArthroCare Corporation
  • Jan Hewett, Director, IRBMED, University of Michigan Medical School
  • Dianne Gobin, Associate Director, PMO, MannKind

5:15 p.m. – 6:15 p.m.

Networking Reception

Medical Device Track

11:20 a.m. – 11:30 a.m.

Moderator Comments — Dan O’Leary, President, Ombu Enterprises

11:30 a.m. – 12:15 p.m.

Take-Home Checklist: The Most Important Tasks to Be Completed Two Weeks Before a Scheduled Inspection
“Hello, it’s the FDA.” A simple phone call can start your next scheduled inspection. Once you hang up the phone you better start preparing. The lead time the FDA provides is variable, but usually they allow at least two weeks of prep time. This checklist-driven presentation will teach attendees the priorities of the last 14 days leading up to the inspection, how to staff-up for the inspection and proven tips for managing data and documentation during the crunch time. Each attendee will take home a copy of a checklist that can be adapted to a specific company.

Attendees will learn:

  • How to galvanize your staff to prepare for an inspection
  • Priority planning to ensure the 14 days before your inspection are productive
  • Document management, retention and access policies that help FDA inspectors do their jobs

Connie Hoy, Vice President, RA/QA, Cutera

12:15 p.m. – 1:00 p.m.

FDA’s Requirements for Trending QSR Data: Best Practices for Devicemakers to Avoid This Emerging “Pinch Point”
Since 2009, warning letter citations make clear that it’s no longer enough for you to look back at the data and then react to quality problems. You are now expected to trend your quality data. In fact, the FDA wants you to maintain a 24/7 state of control by proactively monitoring your quality systems. And compliance isn’t optional, despite the fact that your information sits isolated in “data silos” like complaints and OOS results — making your task of identifying trends nearly impossible.

 

Attendees will learn:

  • Best practices to master a troubling regulatory standard
  • Sources of quality data, including minimums, and suggestions for company-specific measures
  • The latest in principal trending and statistical methodologies
  • Tried-and-tested reporting tools, dashboards and management review techniques

James Eric Miller, Senior Quality Analyst, Core Quality Systems, Roche Diagnostics

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

Combating CAPA: The Device Industry’s #1 Warning Letter Observation
Devicemakers are on notice: Clean up your CAPA act or you will face sanctions. And plenty of devicemakers already are. CAPA violations are the #1 source of device-related citations. In frank and pointed language, the FDA vows to speed warning letter issuance, make re-inspections a top priority ... even pursue aggressive enforcement without warning letters. But here’s the silver lining: Devicemakers that demonstrate their CAPA programs are effective and adequate are in line for the FDA’s blessing in the form of close-out letters. If you're overhauling your CAPA program, or are just looking for a few tweaks to take it to the next level, this presentation is for you.

Attendees will learn:

  • How to approach a major overhaul of your CAPA program — where to start first and what are your compliance priorities while in the midst of the conversion
  • 5 tips that can take a CAPA program from acceptable to best-in-class
  • What the FDA expects from your CAPA program and why most firms fail to deliver

Goldy Singh, Director of Quality Assurance and Regulatory Affairs, Natus Medical

2:45 p.m. – 3:30 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 systems regulation, with four primary areas chosen to focus the inspection. The four top subsystems are: management controls, design controls, corrective and preventive actions, and production and process controls. The remaining three subsystems (equipment/facilities control, records/documents/change control, and materials controls) are covered via “linkages” within the QSIT Guide.

Attendees will 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

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 5:00 p.m.

Panel Discussion: Most 483 Observations Can Be Traced Back to Training — Deploying the Newest and Most Successful “Learning” Methods to Curb 483s
The FDA has been placing ever-increasing pressure on firms to improve their training programs to assure employees are truly trained and not just reportedly trained. While this appears relatively simple, companies continually fall short. Recently, the FDA has specifically indentified inadequate employee training within 483s and warning letters. Experts suggest that medical device firms need to convert their organizations from a “training-based” environment to a “learning-based” environment. But how? Join your colleagues for this engaging look at what’s working in device company training programs and how they are succeeding in developing a learning mindset among their manufacturing and production employees.

Panelists include:

  • Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
  • Kimberly Zizik, Director, Corporate QA/RA, Baxa
  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding

5:15 p.m. – 6:15 p.m.

Networking Reception

Clinical Trials Track

11:15 a.m.–11:30 a.m.

Moderator Comments — Kit Howard, Clinical Data Management, Standards and Quality Consultant, Kestrel Consultants

11:30 a.m. – 12:15 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 trials, including suggestions for planning and conducting a quality clinical trial, and ideas for analyzing and working through problems in on-going studies.

Attendees will learn:

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

Anne Hawthorn, J.D., Chief, Special Investigations Branch, Division of Bioresearch Monitoring, Office of Compliance, CDRH, FDA

12:15 p.m. – 1:00 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. This presentation, will focus on efforts to harmonize clinical trial regulations to improve quality and compliance.

Attendees will learn:

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

Ann Meeker-O'Connell, Acting Associate Director, Risk Science, Intelligence and Prioritization, Office of Scientific Investigation, Office of Compliance, CDER, FDA

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

Cloud Computing, Databases, Tablets and ePRO: Best Practices for Conducting Audits of Electronic Hardware and Software Used in Clinical Trial Operations
Clinical IT managers are under pressure to implement money-saving, trial-accelerating, staff- and patient-friendly advancements every day. So many are turning to cloud computing, ePRO and cutting-edge computer database management tools. But somewhere in the process, the basics of Part 11 and validation got lost. Don’t let the significant advances these new technologies can bring to your trial be lost due to a failed inspection. Take a moment to understand how recent FDA guidance effects clinical trial IT management and be assured you — and your technology — pass your next inspection.

Attendees will learn:

  • How the FDA’s recent Electronic Source Documentation guidance plays into an inspection
  • Where the regulatory responsibility lies when using cloud-based or SaaS offerings

Speaker To Be Determined

2:45 p.m. – 3:30 p.m.

Clinical SOPs: Hard to Write and Tougher to Teach — Benchmarks on What’s Working and What’s Not
One of the top causes of FDA citations during clinical inspections is the failure to establish and follow adequate standard operating procedures (SOPs). But it doesn’t have to be that way. This session will describe best practices in how to write SOPs and train your staff to follow them. It will also benchmark what works and what doesn’t. Don’t waste time trying and failing. In 45 fast-moving minutes, attendees of this session will understand when their SOPs are too complex and destined to fail or when they are too vague and risk 483 observations.

Attendees will learn:

  • What’s working — and what’s not — regarding clinical SOPs
  • How to assure that the proper level of detail is found in your SOPs to assure your staff actually “gets” the training you need to provide
  • Reviews of warning letters to show how mismanagement of SOPs can directly result in a regulatory violation

Terri Kelly, President, Achieve Quality, Inc.

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 5:00 p.m.

Panel Discussion: Clinical Quality Assurance Audits — Can You Play Detective and Valued Partner at the Same Time?
Clinical trial sponsors rely on clinical quality assurance (CQA) auditors to find vulnerabilities before noncompliance can shut down their studies. But with millions of dollars and decades of research at stake, study staffers aren’t always eager to cooperate. That’s why even the most experienced CQA auditors must apply the necessary tools and skills to the CQA function. This in-depth panel discussion will focus on the latest techniques auditors can use to assure that their studies will pass FDA scrutiny. Be prepared to take plenty of notes, as the tips and tricks — from both panelists and attendees — will be coming fast and furious.

Panelists include:

  • Kim Armbrust, Associate Director, GCP Quality Compliance, MedImmune
  • Amy Hansen, Manager, GCP Services, The Weinberg Group, Inc.
  • Cecilia Matos-Rosa, Senior Quality Assurance Auditor-GCP, AMAG Pharmaceuticals

5:15 p.m. – 6:15 p.m.

Networking Reception

Plenary – DAY TWO – Thursday, Oct. 6

8:30 a.m. – 9:00 a.m.

Registration and Continental Breakfast

8:45 a.m. – 9:00 a.m.

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

9:00 a.m. – 10:00 a.m.

Minimizing Your Risks under Annex 11 and Part 11: What FDA and Global Regulators Now Expect
Everywhere you turn, inspector scrutiny of data integrity at manufacturing, clinical and laboratory sites is increasing. The FDA’s highly-touted Part 11 “add-on” inspections are uncovering a host of industry mistakes and misconceptions. Coupled with the agency’s recruitment of more tech-savvy inspectors, the amount of 483 observations and warning letters focused on poor systems management is bound to rise. Abroad, you face even more requirements under the EU’s new Annex 11, including auditing service providers, qualifying your IT infrastructure, and managing lifecycle risks.

Attendees will learn:

  • 5 key targets of FDA and global investigators when they review your computerized systems
  • Lessons from recent and landmark warning letters
  • What’s on the horizon: Part 11 revision? FDA adoption of Annex 11 provisions?

Martin Browning, President and Co-Founder, EduQuest; Former Special Assistant to FDA’s Associate Commissioner for Regulatory Affairs and Vice Chair of the FDA’s Electronic Records and Signatures Working Group, which drafted the original 21 CFR Part 11 regulation

10:00 a.m. – 11:00 a.m.

Understanding the EMA’s Proposed Waiver Policy for Compliant U.S. Plants
As the drug and device industries continue to globalize, regulators are increasingly being asked to do more inspections with fewer resources. In June, the EMA proposed waiving inspections of US plants in some cases — although the decision-making criteria has not been finalized. The EMA believes that fostering greater cooperation with the FDA and other regulatory bodies will increase confidence in their inspectional decision-making and reduce multiple inspections of the same facility.

Attendees will learn:

  • What the EMA is looking for as it identifies US plants that could fall under its waiver policy
  • Examples of how the EMA and the FDA share inspectional and compliance resources and intelligence to reduce burdens for drug and device firms

Speaker to be Determined

11:00 a.m. – 12:00 p.m.

Update on FDA’s Pathway to Global Product Safety and Quality Initiative
Deputy Commissioner for Globalization and Regulatory Operations, Ms. Deborah Autor, will discuss the agency's pathway to global product safety and quality. With emerging new challenges and a four-fold increase in the volume of FDA-regulated imports from just a decade ago and an expectation for continuing increases, FDA leadership developed the Pathway to Global Product Safety and Quality to position the agency to meet these emerging challenges. Following the presentation, time will be allocated for an interactive question and answer session with Ms. Autor and ORA Director of Regional Operations David Elder.

Attendees will learn:

  • Updates on the Pathway to Global Product Safety and Quality initiative
  • Understand FDA's approach and expectations
  • Recognize opportunities where the industry itself can be proactive in securing their supply chain and promoting global product safety and quality

Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, OC, FDA

David Elder, Director, Office of Regional Affairs, ORA, FDA

12:00 p.m. – 12:10 p.m.

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

12:00 p.m.

Conference Adjournment