Inspections-Summit-2012-Agenda

PRE-CONFERENCE WORKSHOPS – Wednesday, Sept. 19, 2012

12:00 p.m. – 1:00 p.m.

Registration

1:00 p.m. – 4:00 p.m.

Drugs and Biologics: Are You Gambling with Your Next Inspection?  Improving the Odds of a Favorable Outcome
This pre-conference workshop will focus on a risk-based approach to inspection preparation.  Case studies that relate to current FDA areas of focus during inspections will be used throughout the workshop, where participants will work in teams.  Each case study will represent a scenario with multiple paths that could be chosen; the team will select what they feel is the best path.  At the end of the workshop, the team will get a score based on their choices, and the score will relate to a potential inspection outcome:  NAI (no action indicated); VAI (voluntary action indicated - minor 483); OAI (official action indicated - WL).  The team with the highest score will receive a prize.

Attendees will learn:

  • How to develop a comprehensive strategy to ensure you have comprehended risks to your inspection
  • Tips for preparing your SMEs to address risks with FDA investigators
  • Best practices for understanding your risks and how they relate to current FDA trends
  • Experiential learning through simulating inspection scenarios
  • Application of concepts through simulated audit case studies during the workshop

1:00 p.m. – 4:00 p.m.

Medical Devices: Back to the Drawing Board — Overhauling Your Complaint Compliance System
This pre-conference 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 link 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:

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

1:00 p.m. – 4:00 p.m.

Clinical Trials: Beyond Pregnant Males — Understanding and Achieving Quality in Clinical Research Data
This pre-conference workshop will dive deep into a 12-element clinical quality assurance management program.  With a legion of newly hired and trained investigators, the FDA is coming down hard on complying with Good Clinical Practices (GCP).  The FDA is focusing on sponsors and investigators for failing to properly conduct numerous aspects of clinical research.  Compliance hotspots run the gamut from informed consent to recent requirements that sponsors report even the suspicion of clinical trial data falsification within 45 days.  Running a compliant clinical trial has never been harder.

Attendees will:

  • Best practices for management control processes (quality and operational metrics, etc)
  • Developing policies and procedures with supporting process maps
  • Understanding the ins and outs of document management and control systems
  • Conducting comprehensive independent audits and reviews
  • Sustaining a robust clinical monitoring program
  • How the CAPA process fits in CQA
  • Tips for site/investigator management
  • Selecting and qualifying the best suppliers
  • What software quality assurance for data management is
  • Why complaint management processes are crucial
  • Effective inventory management controls
  • How to boost your scientific and operational training program

Plenary and Tracks – DAY ONE – Thursday, Sept. 20, 2012

8:00 a.m. – 8:45 a.m.

Registration and Continental Breakfast

8:45 a.m. – 9:00 a.m.

Opening Comments

9:00 a.m. – 10:00 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 FDA faces. Discover ways to anticipate the next import crisis, avert the next large-scale product recall or identify an emerging safety signal. The FDA expects industry to comply with regulations.  Failure to do so requires swift and clear action.  In this presentation, the FDA will discuss the agency's position on enforcement and compliance in support of achieving the overriding purpose of the agency — protecting the public health.

Attendees will learn:

  • Where the FDA’s enforcement and compliance focus is directed
  • How building a compliance culture is good business
  • How recent enforcement cases could have been avoided

10:00 a.m. – 11:00 a.m.

FDA and the 2012 U.S. Presidential Election
Without picking sides: what issues face the FDA after the election and in 2013? How might the agency be affected by whether President Barack Obama is given another four-year term or challenger Mitt Romney is elected President?  President Obama has not yet issued any statements about the FDA on his campaign website. However, based on the past 3 ½ years, he supports the agency and its mission and sees that it’s role is likely to continue to grow because of globalization, public health and safety, and the need to encourage innovation.  The Republican candidate, Mitt Romney, has not yet issued any specific policy statements on the FDA. However, he appeared at a medical device company event in late March and suggested that the FDA is part of an “attack on free enterprise” by “the thousands upon thousands of bureaucrats that work in Washington.”

Attendees will learn:

  • Is Obama's overall regulatory positioning becoming more or less favorable to the FDA?
  • Romney has suggested requiring congressional approval of all new “major” regulations — would that affect the FDA?
  • Might Commissioner Hamburg step down after an Obama reelection?
  • If Romney won, how long would it take to confirm a new commissioner?

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

11:30 a.m. – 12:15 p.m.

Organizational Structure of the FDA – Emphasis on the Office of Regulatory Affairs (ORA) and Field Operations
Have you ever wondered how the FDA’s field offices interact with district and headquarters staff?  This presentation will walk you through the ins and outs of the FDA structure, with emphasis on the Office of Regulatory Affairs (ORA) and field operations.

Attendees will learn:

  • How FDA headquarters and centers interact regarding inspections
  • ORA's organizational structure — the who, what, where, when and why of how field offices and districts are structured
  • How ORA interacts with the district offices

12:15 p.m. – 1:00 p.m.

Preparing for FDA and EMA Clinical Safety and Postmarketing Pharmacovigilance Inspections: Forewarned is Forearmed
In our global safety environment, regulatory compliance and quality systems are critical. Companies need to be aware of the clinical safety and postmarketing pharmacovigilance inspectional programs of both the FDA and Member State regulatory agencies that serve as lead inspectorates for EMA. Crafting effective procedural documents and understanding the relationship between quality processes and compliance can help companies prepare for inspections by regulators of both regions.

Attendees will learn:

  • The similarities and differences between US and EU inspectional approaches in clinical safety and postmarketing pharmacovigilance
  • Insights into attributes that make procedural documents effective
  • How to prepare for safety-related regulatory inspections

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

EU and US Inspectional Approach for Data Integrity — The Cornerstone for Future Inspections
A number of EMA/FDA joint inspection pilot projects have been initiated to ensure that international collaboration can help better distribute inspection capacity, reducing unnecessary duplication.  According to EMA, increased transparency and visibility of inspections performed by participating authorities allows for a successful collaboration between authorities on sites of common interest and increases the number of inspections performed.  Today, computerized automation is a key element of any manufacturing and distribution area of pharmaceutical manufacturing; therefore, the requirements for data integrity are now considered a fundamental expectation for all types of systems, including laboratory and process control systems.

Attendees will learn:

  • Analogies and differences between European and US regulations, which address the use of computerized systems in regulated activities
  • Part 11 and Annex 11: a common approach to computerized systems  validation compliance
  • Understanding data integrity as the cornerstone for future inspections

2:45 p.m. – 3:30 p.m.

From the Trenches:  How to Survive FDA Preapproval Audits
An FDA preapproval inspection can be an intimidating prospect for drug and biologics manufacturers.  They’re no fun to undergo and impossible to pass without the proper preparation.  And everything rides on them.  But investigators keep taking new angles on everything from material flow and CAPA to supplier and purchasing controls.  This presentation will provide tips and strategies for passing these difficult inspections based on three recent successful cases. 

Attendees will learn:

  • Results from three preapproval inspections, from three foreign manufacturing sites, across three countries
  • Top 5 things the FDA typically focuses on during preapproval inspections
  • Best practices for educating staff on the importance of preapproval inspections
  • #1 thing that gets overlooked when preparing for an inspection

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 Worst — 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 panelists have seen it all and are here to give you the “skinny” on how to pass your upcoming inspection with flying colors.

5:00 p.m. – 6:30 p.m.

Networking Reception

Medical Device Track

11:20 a.m. – 11:30 a.m.

Moderator Comments

11:30 a.m. – 12:15 p.m.

Back to Basics on What Comprises the Device History Record – Addressing the Sneaky Requirements
As the industry moves forward with the implementation of advanced technological tools, it is increasingly important to have a thorough understanding of how the various Part 820 subsystems are woven together as part of the implementation of these more complex electronic systems.  For example, the industry is rapidly moving forward with e-DHRs, but it is important to realize how other subsystems, such as process validation and general production process controls, also have a link to the DHR. This presentation will not only include a review of the obvious requirements for the DHR, but also the “sneakier” requirements that have the potential to be easily overlooked.

Attendees will learn:

  • Receive a refresher of DHR, DMR, e-DHR
  • Uncover the “sneaky” DHR requirements defined in 820.70 and 820.75
  • Discuss the technological advances from chart recorders/paper DHRs to paperless facilities
  • Learn best practice approaches to assuring data is identified, reviewed and properly maintained
  • Be introduced to the novel technique of review by exception (GAMP Good Practice MES Guide)

12:15 p.m. – 1:00 p.m.

How to Effectively Present Your Complaint and Adverse Event Files to the FDA and Reduce Your Risk of a 483
FDA inspections for any class device will always review complaints and adverse event files.   It is critical to have well-documented files and the ability to present these to the investigator in a manner that is clear and concise.  This presentation will review contents for your files (including what not to include in your files!) and discuss how to present this information to the FDA in a truthful and effective manner.  The ability to present complaint and adverse event information can be critical to the outcome of your inspection.

Attendees will learn:

  • The importance of the truth — how to present files that provide an accurate picture of your product
  • What to include — and NOT include — in your complaint files and adverse event files
  • Understanding when too much information becomes dangerous
  • The importance of trending — and why the FDA is focusing on your ability to properly trend complaints and AERs
  • Top 10 complaint file red flags

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 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

2:45 p.m. – 3:30 p.m.

Best Practices in FDA 483 and Warning Letter Management and Recovery
In the current enforcement environment outlined by FDA Commissioner Dr. Margaret Hamburg, the agency expects responses to Form 483s and warning letters within 15 business days. Preparing comprehensive, persuasive responses to the FDA findings are critical to a company's success in regaining a positive compliance profile. Responses must incorporate well-designed and well-written corrective action plans that will convey a commitment for effective and sustained compliance.

Attendees will learn:

  • How to manage Form 483s and warning letters, including recovery from financial and competitor impact
  • Best practices in preparing a response that meets FDA expectations
  • Understanding your audience when writing your response
  • Whether an effective response to a Form 483 can avert a warning letter

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 5:00 p.m.

Panel:  Emerging Concerns for Device and Diagnostic Manufacturers
The traditional “medical device” market is undergoing significant change.  Diagnostics have been rapidly advancing with no end in sight.  On the horizon are medical device “apps,” with myriad questions about how they will be approved and questions about their safety and long-term effectiveness.  Industry observers are concerned about how the FDA will enforce the new Unique Device Identifier rule.  And an increasing percentage of device suppliers are hard-to-manage virtual companies.  This panel will focus on identifying emerging inspection trends.

Attendees will learn:

  • How FDA investigators are trained to address inspections of emerging products – i.e., medical device apps
  • If UDI will become fertile ground for new 483 violations
  • How to audit a “virtual” supplier and what records the FDA expects  you to keep

5:00 p.m. – 6:30 p.m.

Networking Reception

Clinical Trials Track

11:20 a.m.–11:30 a.m.

Moderator Comments

11:30 a.m. – 12:15 p.m.

Determining What’s Needed to Conduct Successful IND and IDE Studies
As study protocols grow more complex, one in seven clinical trials being conducted under an IND/IDE has at least one active complaint about investigator noncompliance or possible fraud — mainly for protocol violations.  Recent studies of clinical trial protocols have revealed a burgeoning number of protocol amendments, as sponsors try to squeeze more results out of sites in a shorter period of time.

Attendees will learn:

  • The latest regulatory requirements and how they should be reflected in your study designs
  • The importance of validation and why the FDA focuses so much attention on it
  • Data, data everywhere — proactive approaches to understanding database requirements

12:15 p.m. – 1:00 p.m.

Part 11 Compliance in the Cloud — Challenges and Complexities of Validated Systems
The cloud computing market space — including Infrastructure-as-a-Service (IaaS) — is approaching $17B in revenues by 2013, with annual growth rates of more than 25%.  Federal agencies, including the FDA, NIH and CMS, have been directed to move as much as 20% of their mission-critical infrastructure to cloud-based architectures. This presentation will discuss and debate the challenges, complexities and realities of achieving compliance with health authority guidelines, particularly for laboratory and clinical research validated systems.

Attendees will learn:

  • Case studies that demonstrate that organizations large and small are moving regulated systems to cloud-based technology
  • What’s working — and more importantly, what’s not — when moving validated data to the cloud
  • Major myths about cloud implementations — particularly around security, controls and shared responsibility

1:00 p.m. – 2:00 p.m.

Lunch

2:00 p.m. – 2:45 p.m.

Recognizing Serious Adverse Events and Complying with the Different Rules That Govern Their Reporting
Many research facilities are drowning in adverse event data and they aren't sure how or when to report it. The rules tend to differ depending on who is doing the reporting and to whom the report is being made.  Both the FDA and HHS's Office of Human Research Protections (OHRP) have stated in guidances that adverse events should only be reported to an institutional review board (IRB) if unanticipated problems occur. But the OHRP guidance admits that it may be difficult to determine whether a particular incident, experience or outcome is unexpected.  So, what is the right level of reporting?

Attendees will learn:

  • The key rules and requirements of the FDA and OHRP
  • What the FDA considers a reportable event and how it is often misinterpreted
  • How to recognize a serious adverse event and then comply with the different rules that govern it
  • The most common reporting errors and how to avoid them

2:45 p.m. – 3:30 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.  The historical focus on subject well-being and the accuracy and consistency of data — while always very important — needs to be coupled with the aim to improve quality of the clinical trial process to increase its efficiency and effectiveness for sponsors, CROs, investigators and patients.  In this presentation, the FDA will discuss efforts to harmonize clinical trial regulations to improve quality and compliance.

Attendees will learn:

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

3:30 p.m. – 3:45 p.m.

Refreshment Break

3:45 p.m. – 5:00 p.m.

Panel Discussion:  Understanding Proper FDAAA/Title VIII Reporting and Its Inspectional Implications
The Food and Drug Administration Amendments Act of 2007 (FDAAA), specifically Section VIII, requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the National Institutes of Health’s (NIH) ClinicalTrials.gov website.  NIH, FDA and OIG are ramping up enforcement of the requirements and increasing pressure on firms to report all “applicable” clinical trials. In 2010, three firms were mandated to comply with registration and reporting requirements through OIG corporate integrity agreements.  This panel will discuss how the FDA feels the program is doing and best practices to remain compliant.

Attendees will learn:

  • What the FDAAA/Title VIII says and how its provisions impact your clinical trials
  • Best practices to manage disclosure of negative or nonsignificant results
  • Avoiding mistakes when applying the regulatory exemptions provisions
  • Reassessing audit and monitoring processes for results posting

5:00 p.m. – 6:30 p.m.

Networking Reception

Plenary – DAY TWO – Friday, Sept. 21, 2012

8:00 a.m. – 8:45 a.m.

Registration and Continental Breakfast

8:45 a.m. – 9:00 a.m.

Opening Comments

9:00 a.m. – 10:00 a.m.

Lessons Learned: How Product Failures, Recalls and GMP/QSR Problems Trigger FDA Enforcement Actions
FDA administrative and judicial enforcement actions have increased substantially in the past few years. Many companies and corporate officials fail to heed important warning signs of impending trouble and are surprised when the FDA takes enforcement action. The consequences can be catastrophic to the company, its employees and its customer base. This session will share important lessons learned from actual case studies.

Attendees will learn:

  • The early warning signs of problems in products and quality systems
  • What key actions should be taken to contain problems and avoid enforcement
  • How to engage in an effective dialogue with the FDA to instill its confidence in your company
  • When to seek outside consulting and legal expertise and how they can help

10:00 a.m. – 10:15 a.m.

Refreshment Break

10:15 a.m. – 11:45 p.m.

Panel Discussion: Beyond Compliance to Quality
Facility inspections, citations and enforcement actions remain important, but such traditional regulatory approaches may not be enough as the FDA faces an ever-increasing global environment. Innovative strategies to promote product quality are emerging. This exclusive panel discussion featuring, CDRH, CDER, CBER, ORA and other FDA representatives, will examine and educate the industry on current initiatives that move beyond the inspect-and-cite model to collaborative approaches that promote product quality and performance.

Attendees will learn:

  • What collaboration on product quality looks like across the FDA
  • How innovative and more traditional regulatory approaches work in sync
  • The FDA's global regulatory vision
  • How the FDA is engaging stakeholders around quality
  • Other initiatives that similarly focus on quality outcomes

11:45 p.m. – 12:00 p.m.

Closing Comments

12:00 p.m.

Conference Adjournment