SEVENTH ANNUAL FDA INSPECTIONS SUMMIT · 1:00 p.m. – 4:00 p.m. Medical devices: Back to the drawing Board — Overhauling your Complaint Compliance system This pre-conference workshop

300 N. Washington St., Suite 200Falls Church, VA 22046-3431

visit www.fdAinspectionssummit.com or call (888) 838-5578

this is the "go-to" event for regulatory, compliance and quality assurance professionals

— You'll leave this summit much better prepared to face your next inspection!

The Industry's Most Attended Summit Focused on Inspections and Compliance Polices

Presented by FDAnews

steve niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding; former Deputy Associate Commissioner, Regulatory Operations and Chief Operating Officer, ORA, FDA

Ron Johnson, President, Becker & Associates Consulting, Inc.; former Director of Compliance, CDRH, FDA

dr. stephen goldman, Managing Member, Stephen A. Goldman Consulting Services; former first Medical Director of FDA's MedWatch

dr. gilda d’Incerti, CEO, Pharma Quality Europe

steven grossman, President, HPS Group; Deputy Executive Director, Alliance for a Stronger FDA; Publisher, FDA Matters: The Grossman FDA Report; former Deputy Assistant Secretary for Health, HHS

lindsey Howard, Vice President, Qual-ity Assurance North America, QIAGEN

deborah geyman, Senior Manager, Corporate Quality Audit, St. Jude Medical

Connie Hoy, Vice President, RA/QA, Cutera

Julie larsen, Director, Inspection Readiness Services, BioTeknica

dr. Jeanne Mattern, Director, QHS Regulatory Compliance Office, Cleveland Clinic

dan O'leary, President, Ombu Enterprises

Matt Quirk, Manager, Clinical QA, St. Jude Medical

kenneth White, Principal Scientist, Clinical Research and Bioscience Group, Social & Scientific Systems

Christina arnt, Post Market Surveillance Manager, St. Jude Medical

BArBArA K. ImmelChair, president, immel resources llCA leading consultant in quality systems, regulatory compliance and training for more than 30 years, barbara K. immel is one of the most listened-to voices in fdA-regulated industry. she chaired last year’s summit. “Barbara was simply fantastic,” said attendee Nicole Landreville, Xltek.

SEVENTH ANNUAL

FDA INSPECTIONS SUMMIT

Steve Silverman, Director, Office of Compliance, CDRH, FDA

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

INDUSTRY FACULTY

FDA FACULTY

Sept. 19 – 21, 2012 • Bethesda North Marriott Hotel & Conference Center • Bethesda, MD

Visit www.FDAInspectionsSummit.com or call (888) 838-5578

Day One: tHuRSDay, SePt. 208:00 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 en-forcement and ComplianceThe traditional tools of a regulatory agency are regulation, approval or disapproval of applica-tions, and enforcement. Globalization intensi-fies 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 indus-try to comply with regulations. In this presenta-tion, 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 com-pliance 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 electionWithout 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 state-ments about the FDA on his campaign website. 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 sug-gested that the FDA is part of an “attack on free enterprise” by “the thousands upon thousands of bureaucrats that work in Washington.” At-tendees will learn:

• Is Obama's overall regulatory positioning becoming more or less favorable to the FDA?

• Romney has suggested requiring con-gressional 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

n track 1 — drug & Biologicsn track 2 — Medical devicesn 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 struc-ture of the fda – emphasis on the Office of Regulatory affairs (ORa) and field OperationsHave 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 em-phasis on the Office of Regulatory Affairs (ORA) and field operations. Attendees will learn:

• How FDA headquarters and centers inter-act 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 forearmedIn 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

Seventh AnnuAl FDA InSpectIonS SummIt Sept. 19–21, 2012 • Bethesda North Marriott Hotel & Conference Center • Bethesda, MD

12:00 p.m. – 1:00 p.m. Registration

1:00 p.m. – 4:00 p.m. drugs and Biologics: are you gam-bling with your next Inspection? Improving the Odds of a favorable OutcomeThis pre-conference workshop will focus on a risk-based ap-proach to inspection preparation. Case studies that relate to current FDA areas of focus during inspections will be used throughout the workshop. Each case study will represent a scenario with multiple paths that could be chosen; Teams will select what they feel is the best path. Teams 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 com-prehended 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 systemThis 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. Because com-

plaints 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 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• When a manufacturer should investigate complaints using the cor-

rective action system• When to report a complaint as an MDR to the FDA (Part 803)• How complaints relate to corrections and removals (Part 806)

1:00 p.m. – 4:00 p.m. Clinical trials: Beyond Pregnant Males — Understanding and achieving Quality in Clinical Research dataThis pre-conference workshop will dive deep into a 12-ele-ment 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). 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. Attendees will learn:

• 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• Why complaint management processes are crucial• How to boost your scientific and operational training program

SPecial PRecOnFeRence WORkSHOPS – WeDneSDay, SePt. 19

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 pharma-covigilance

• Insights into attributes that make proce-dural documents effective

• How to prepare for safety-related regula-tory 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 Corner-stone for future InspectionsA number of EMA/FDA joint inspection pilot projects have been initiated to ensure that inter-national collaboration can help better distribute inspection capacity, reducing unnecessary duplication. Today, computerized automation is a key element of any manufacturing and distri-bution 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 ad-dress the use of computerized systems in regulated activities

• Part 11 and Annex 11: a common ap-proach to computerized systems valida-tion compliance

• Understanding data integrity as the cor-nerstone for future inspections

2:45 p.m. – 3:30 p.m. from the trenches: How to survive fda Preapproval auditsAn FDA preapproval inspection can be an intimi-dating prospect for drug and biologics manufactur-ers. They’re no fun to undergo and impossible to pass without the proper preparation. And every-thing 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 inspec-tions, 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 pre-paring 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.


meDical Device tRack


11:30 a.m. – 12:15 p.m. Back to Basics on What Comprises the device History Record – addressing the sneaky RequirementsAs the industry moves forward, it is increasingly important to have a thorough understanding of how the various Part 820 subsystems are wo-ven together as part of the implementation of complex electronic systems. For example, the industry is rapidly moving forward with e-DHRs, but it is important to realize how other subsys-tems, 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. At-tendees 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 as-suring data is identified, reviewed and properly maintained

• Be introduced to the novel technique of review by exception (GAMP Good Prac-tice MES Guide)

12:15 p.m. – 1:00 p.m. How to effectively Pres-ent your Complaint and adverse event files to the fda and Reduce your Risk of a 483FDA 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 presenta-tion 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 pres-ent complaint and adverse event information can be critical to the outcome of your inspection. Attendees will learn:

• The importance of the truth — how to pres-ent 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 togetherThe 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, de-sign controls, corrective and preventive actions, and production and process controls. The re-maining 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 RecoveryIn the current enforcement environment the agency expects responses to Form 483s and warning letters within 15 business days. Prepar-ing comprehensive, persuasive responses to the FDA findings are critical to a company's suc-cess 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 writ-ing 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 dIsCUssIOn: 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 ad-dress 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


clinical tRialS tRack


11:30 a.m. – 12:15 p.m. determining What’s needed to Conduct successful Ind and Ide studiesAs 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 burgeon-ing number of protocol amendments, as spon-sors 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 — includ-ing 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, complexi-ties and realities of achieving compliance with health authority guidelines, particularly for labo-ratory and clinical research validated systems.Attendees will learn:

• Case studies that demonstrate that organizations large and small are mov-ing 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 implementa-tions — 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 ReportingMany 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. It may be difficult to deter-mine 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 Regulato-ry approaches to Clinical trials to Improve Quality and ComplianceThe 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 compli-ance 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 ImplicationsThe 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. This panel will discuss how the FDA feels the program is doing and best practices to remain compliant. Attendees will learn:

• What 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 pro-

cesses for results posting


Day tWO: tHuRSDay, SePt. 21

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 conse-quences can be catastrophic to the company, its employees and its customer base. This ses-sion 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 con-tain 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 a.m. Panel discussion: Beyond Compliance to QualityFacility inspections, citations and enforcement actions remain important, but such traditional regulatory approaches may not be enough as the FDA faces an ever-increasing global environ-ment. 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 regu-latory 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 a.m. – 12:00 p.m. Closing Comments

12:00 p.m. Conference adjournment

Summit at-a-glance

Abbott Laboratories Abbott MolecularAbraxis BioScienceActavis Pharmaceuticals Aderans Research Institute AdolorAdvanced Sterilization ProductsAffymaxAir Liquide AmericaAlign TechnologyAlliance Healthcare Information American College of RadiologyAmerican Medical SystemsAmgenAmphastar PharmaceuticalsAnderson PackagingApoPharmaApplied Medical ResourcesArthrexAvedroAxSource ConsultingAzur PharmaBasilea Pharmaceutica InternationalBaxa BaxterBD Diabetes CareBenevue Medical Biomimetics Bio-Rad LaboratoriesBiosante Pharmaceuticals BioTeknicaBiotheraBoehringer IngelheimBoston Analytical Boston Scientific Bristol-Myers Squibb Burpee Materials TechnologyCadista PharmaceuticalsCareFusionCentocor Ortho Biotech ServicesChattem Clarkston ConsultingColoplastConvatec Corium International CovidienCR BardDeka ResearchDentsply Dept. of Health & Human Services Dipl.-Ing. Thonhauser GmbHDPT LaboratoriesDun & Bradsreet

Dynamic PharmaceuticalsDynPort VaccineEli LillyEmory UniversityEndo Pharmaceuticals EnergizerEstee LauderEthicon Endo-SurgeryFalcon Consulting Group Farmhispania S.A.Ferno Fisher & Paykel HealthcareFDAFort Wayne Metals Fujirebio DiagnosticsGE HealthcareGedeon RichterGenentechGeniconGilead SciencesGlobus MedicalGolden State Medical SupplyGreer LaboratoriesHaemoneticsHoffmann-La RocheHogan Lovells USi3 InVentiv Health i3 StatprobeInspire PharmaceuticalsInternational LabsInternational TechnidyneInvivodataIronwood PharmaceuticalsJohnson & JohnsonKCI MedicalKinetic ConceptsLNK InternationalLyne LaboratoriesMcNeil Consumer HealthcareMedcompMedicisMedImmuneMedtronicMerck Sharp & DohmeMerz Pharmaceuticals GmbHMillennium PharmaceuticalsMindrayMorphotekMPI Research Nephron PharmaceuticalsNew York University Medical CenterNorwich PharmaceuticalsNovartisNovo Nordisk

NxStage MedicalNyproNYU Cancer InstituteOhio MedicalOliver-Tolas Healthcare PackagingOnyx Pharmaceuticals Optimer Pharmaceuticals PatheonPerkinElmerPerrigo PfizerPhilips HealthcarePhototheraPlaytex ProductsPoseyPQ Silicas UKPrentke RomichProcter & Gamble QA ConsultingQIAGENReckitt BenckiserRegeneron PharmaceuticalsResMedSage Products SAIC - FrederickSanofi-AventisSarah Cannon Research InstituteSechrist IndustriesShire PharmaceuticalsSigmaSoutheastern TechnologySouthmedicSpineologySt. Jude MedicalSterisStryker BiotechSynthesTactical TherapeuticsTakedaTechnical Resources InternationalTerumo CVSTerumo MedicalTeva USATriVascularUCBUniversity of Miami URL PharmaUTMB - Galveston National LabVDW GMBHVerathonW.O.M. World of Medicine AGWalter Reed Army Institute of ResearchWarner ChilcottWatson Pharmaceuticals

Barbara K. Immel is president of Immel Resources LLC, a management consulting firm specializing in quality systems, regulatory compliance and training. For more than 30 years, Ms. Immel has been one of the most listened-to voices in FDA-regulated industry. She has taught at the Universities of California-Berkeley, Wiscon-sin, Georgia and Stanford; authored more than 50 articles in industry journals; and written the Quality Assur-ance chapter in Dekker’s Encyclopedia of Pharmaceutical Technology. She is a former compliance columnist for BioPharm Magazine and is currently the editor of the Immel Report™ newsletter.

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SEVENTH ANNUAL FDA INSPECTIONS SUMMIT · 1:00 p.m. – 4:00 p.m. Medical devices: Back to the drawing Board — Overhauling your Complaint Compliance system This pre-conference workshop