Tenth Annual FDA Inspections Summit

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Co-Chairs announced for the 10th Annual FDA Inspections Summit

John AvellanetJohn Avellanet is Managing Director & Principal of Cerulean Associates. John is an expert advisor to the ISPE GAMP forum on data integrity. He most recently co-authored the book, Pharmaceutical Regulatory Inspections (2014), with several current and former regulatory agency officers, and his industry classic book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, was originally featured in 2011.



Steve NiedelmanSteve Niedelman retired from the FDA in 2006 after a 34 year distinguished career where he served most recently as Deputy Associate Commissioner for Regulatory Operations and Chief Operating Officer. He is currently the Lead Quality Systems and Compliance Consultant at King and Spalding. He participates as a member of the Medical Device Committee at the Food and Drug Law Institute, and as a member of the Editorial Review Board for FDAnews GMP publications directed at the pharmaceutical and medical device industries.


Julie LarsenJulie Larsen is Senior Partner and Director of Inspection Readiness Services at BioTeknica. She has more than 20 years’ experience with quality assurance and compliance in manufacturing, division, and corporate roles in medical device and pharmaceutical industries. She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement as well as successfully addressing Consent Decree, Warning Letter and 483 responses.


Here is just a sample of what past attendees have said about our Co-Chairs:

John Avellanet
“John always has great examples of checklists & processes that can be utilized as a starting point to make a system more compliant.”

Steve Niedelman
“Excellent speaker! very knowledgeable. Great presentation that is excellent to have these types of exercises. Very helpful.”

Julie Larsen
“Knows subject matter extremely well and fielded questions with ease regardless of subject/background.”

The agenda is taking shape.
Click here for the highlights.

Over the past 9 years thousands of industry professionals have attended the FDA Inspections Summit and benefited from the unmatched presentations and panel discussions led by FDA officials and industry experts.

The 2015 Inspections Summit will take place from November 4th to November 6th.

We are in the process of creating a groundbreaking three-day agenda that will provide you with a deep dive into all the key issues confronting regulatory, compliance and quality assurance professionals, with actionable information and insights you can take back and apply immediately.

At The Inspections Summit you can be confidant you'll learn how to improve and better prepare for your next investigation with our tightly focused sessions. These presentations will feature detailed case studies and interactive panels; you're sure to gain fresh ideas and tips that you'll be able to take back to your company.

 

Testimonials From Past Attendees:

“Great discussion and knowledgeable panel. I enjoyed having the FDA give examples in their own words…”

– Dan Lewis, Site Quality Leader, P&G

“The panels were great. Very informative and great discussions.”

– Nancy Carranza, Vice President, Operations, GSMS, Inc.

“Great and interesting sessions. Great panel discussions and attendee participation.”

– Johanna Stamates, Executive Director - Research Compliance & Quality Assurance,
University of Miami

“I certify this Summit a success. ”

– Thomas Hoffman, Compliance, Medtronic

Past Companies That Have Benefited:

Abbott Laboratories
AbbVie
Accenture
Aceto
ACIC Fine Chemicals Inc
ACRC-Cardiology
Actavis
Actavis Pharmaceuticals
Actelion Pharmaceuticals
Adaptimmune
Aderans Research Institute
Advanced Breath Diagnostics
Advanstar Communications
Advocate Health Care
Alexion Pharmaceuticals, Inc.
Alexza Pharmaceuticals
ALK
Allergan
Allergy Laboratories, Inc
Alliance Healthcare Information
Amedra Pharmaceuticals LLC
American Health Packaging
Amgen
Amneal Pharmaceuticals
Amphastar Pharmaceuticals
Apace Packaging
Apopharma, Inc.
Apotex Pharmachem
Arena Pharmaceuticals
Array BioPharma
Arrow International
Arthrex, Inc.
Ascom Inc.
Ashfield Healthcare, LLC
ASP
AstraZeneca
AstraZeneca Biologics
Auditrial LLC
Auxilium Pharmaceuticals
Aveva
AxSource Consulting Inc.
Bausch & Lomb
Baxa Corporation
Baxter Healthcare
Bayer
Beck & Associates
Becker & Associates Consulting, Inc.
Beiersdorf
Benevue Medical
Berlin Heart Gmbh
BioControl-Medical
BioMarin
BioMedical Enterprises
BioMimetic Therapeutics
Biomimetics
BioPharm, Inc.
Biosante Pharmaceuticals
Bioteknica
BioTeknica Engineering & Regulatory Services
Biothera
Boehringer Ingelheim Pharmaceuticals
Boston Analytical
Boston Scientific
Brainlab AG
Braintreelabs
Bristol-Myers Squibb
BSI Healthcare Solutions
BSP
Business Support International
C. R. Bard
CAG USA Inc
CareFusion
Carlsbad Technology, Inc.
CB Fleet
Celgene
Celgene Cellular Therapeutics
Cerulean Associates LLC
Chattem
Chemwerth, Inc.
Church & Dwight
Colgate Oral Pharmaceuticals
Colgate Palmolive
Coloplast
Compliance & Management Assoc.
Compliance Team
ConMed
Convatec
Corcept Therapeutics
Corium International
Covidien
CryoLife, Inc.
CSA Medical
CSL Behring
Cubist Pharmaceuticatis
Cynthia Kisiel-Smith, Inc
Dart NeuroScience
DEKA Research and Development
Deka Research and Development
Deloitte & Touche LLP
Dentsply
Department of Health & Human Services
DePuy Synthes Companies of Johnson & Johnson
Diagnostica Stago Inc.
DPT Laboratories
Dr Reddy's
Draeger Medical Systems, Inc
Duke Clinical Research Institute
DynPort Vaccine Company LLC
EAS Consulting Group
Edwards Lifesciences
Eli Lilly and Company
Em Adams
EMD Millipore
Endo Pharmaceuticals
Energizer
Engerizer Personal Care
Eurofins Lancaster Laboratories
FDA
Ferno
Ferno-Washington, Inc.
Fisher & Paykel Healthcare
Fleet Laboratories
FMS
Focus CVS
Fort Wayne Metals
FORUM Pharmaceuticals Inc.
Foundation for Cancer Research & Education
Fresenius
Fresenius Kabi
Fresenius Medical Care
Fujirebio Diagnostics, Inc.
FutureMatrix Interventional
GE Healthcare
Gedeon Richter
Genentech
Genicon
Gilead Sciences, Inc.
Glatt Air Techniquies
Global Resources International, Inc.
Globus Medical, Inc.
Golden State Medical Suppy, Inc
Greer Laboratories
Greiner
GSK
GSMS, Inc
H&H Medical
Haemonetics
Hi Tech Pharmacal
Hogan Lovells LLP
Hospira, Inc
i3 InVentiv Health
ICON Medical Imaging
Immel Resources LLC
Indicus Pharma
Infuserve America
Instrumentation Laboratory
International Labs
IPS
Isapure
J&J
Johnson & Johnson
Johnson & Johnson Consumer



 

Kao USA, Inc.
Kaplan EduNeering
Kimberly Clark Healthcare
Kimberly-Clark Corp
Kythera Biopharmaceuticals, Inc.
Lachman Consultants
Lannett Co., Inc.
Lantheus Medical Imaging
Lexington Medical Center
Life Technologies
Lifecell Corporation
Lifecore Biomedical
Lnk International, Inc.
Lyne Laboratories
Madriz Services
Magstim
Mako Surgical
McNeil
McNeil Consumer Healthcare
Meda Pharmaceuticals
Medcomp
Medimmune
Medivation
Medline Industries
Medmarc Insurance Group
Medtronic Advanced Energy
Medtronic Diabetes
Medtronic MCO
Medtronic Spinal and Biologics
Medtronic, Inc.
Merck Serono S.A.
Merck Serono SpA
MicroVention
Millenium Pharmaceuticals
MIM Software, Inc.
Mindray
Mortara Instrument
MPI Research
Mylan
NAMSA, Inc.
Natus Medical
Natus Medical Incorporated
Nemschoff
Nephron Pharmaceuticals Corp.
New Mountain Capital
Nexcyon Pharmaceuticals
Nice-Pak Products
Norman Noble, Inc
Norwich Pharmaceuticals, Inc.
Novartis
Novo Nordisk, Inc.
Novum
NxStage Medical, Inc.
Ohio Medical
Olson Frank Weeda
Ombu Enterprises
Omron Healthcare, Inc.
Onyx Pharmaceuticals
Optimer Pharmaceuticals
Orgenix
Ortho Clinical Diagnostics
Orthofix
P&G
Palomar Medical Technologies
PAR Pharmaceutical Companies, Inc.
Paragon Medical
PAREXEL Consulting
Patheon
Patheon Pharmaceuticals
Patton Boggs
PDA
Pediavision
Perkin Elmer, Inc.
Perrigo
Pfizer
Pharma Quality Europe
Pharmaceutics International
Philips Healthcare
Phoenix Healthcare Solutions
Photothera, Inc.
Pii
Pilgrim Quality Solutions
Piramal Imaging GmbH
Playtex Manufacturing
Portola Pharmaceuticals
Posey Company
Prentke Romich Company
Prisma Corporation
PROCAPS S.A.
Procter & Gamble
PSC Biotech
QIAGEN
QMS Consulting
QSR Consulting
QualityHub, Inc.
Quintiles
ResMed, Inc.
Rigaku Raman Technologies
RJ Reynolds
Roche
Roche Diagnostics
Roche Molecular Sytems, Inc.
Sage Products
SAIC
Sandoz International
Sanofi
Sanofi Aventis
Sanofi Pasteur
Sarah Cannon Research Institute
Scant Medical
Secant Medical, Inc.
Seton Medical Center
Shire
Siemens Healthcare Diagnostics
Siemens Medical Solutions Usa, Inc
Sigma, LLC
Smith & Nephew
Solabs
Sorin
Sorin Group
Southeastern Technology
Spectrum Pharmaceuitcals
St. Jude Medical
Standard Process
Stiefel, a GSK Company
Stryker
Sunrise Medical
Syngene International Limited
Takeda Development Center
Taro Pharmaceuticals, Inc.
Team Technologies
Technical Resources
Teleflex, Inc.
Terumo Medical
Teva Pharmaceuticals
Texas A&M University
The Magstim Company
The Silver Sheet
Thermo Fisher Scientific
Thermofisher Scientific
Trillium Health Care Products
Tunstall
TUV SUD America
UCB, Inc.
UI Pharmaceuticals
UL EduNeering
University of Miami
Urology Service at Michael E. DeBakey VA
USHIFU, LLC
VDW GMBH
Vention Medical
Verathon Inc
Vi-Jon
Vistakon
Walter Reed Army Institute of Research
Watson
Wedgewood Pharmacy
West-Ward Pharmaceuticals
World of Medicine AG
Xoran Technologies
Z & B Enterprises, Inc.

 

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