FDAnews Announces: FDA Official Added to 9th Annual FDA Inspections Summit, Oct. 22-24, 2014
9th Annual FDA Inspections Summit Presented by FDAnews; Oct. 22-24, 2014 – Bethesda, MD; www.fdanews.com/InspectionsSummitPR2
Falls Church, VA, October 05, 2014 --(PR.com)-- The nation’s #1 Summit for quality, compliance and inspectional readiness will join together hundreds of the industry’s top professionals for the most anticipated event of 2014
FDAnews is pleased to announce the addition of Phillip Pontikos, Medical Device National Expert within the Office of Regulatory Affairs (ORA) of the FDA. Mr. Pontikos will be presenting two sessions at the 9th Annual FDA Inspections Summit taking place October 22-24, 2014, at the Doubletree Bethesda Hotel in Bethesda, MD.
Mr. Pontikos will be featured in the following sessions:
· A Day in the Life of FDA’s Field Investigators — Current and Former Field Investigators Explain What They Look For and Why and What’s on the Horizon: Panel Discussion
· Most 483 Observations Can Be Traced Back to Training — Deploying the Newest and Most Successful “Learning” Methods to Curb 483s: Panel Discussion
Joining Mr. Pontikos will be an elite group of his colleagues from FDA’s Centers, Directorates and ORA. These include:
· Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office Of The Center Director, CDRH, FDA
· Dr. Neil Stiber, Operations Research Analyst, Office Of Strategic Programs, CDER, FDA
· Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
· Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
· Capt. Cynthia Harris, SRO, Medical Device/Bioresearch Monitor, ORA, FDA, Baltimore District
The 9th Annual FDA Inspections Summit will be an unprecedented gathering of the nation’s most influential and innovative thought leaders in quality, compliance and inspectional readiness. Plus, they are the practitioners, policy makers, and legal advisors who are best equipped to move inspections into 2015 and beyond.
Time is running out and seating is limited. Register today at www.fdanews.com/InspectionsSummitPR2.
Additional confirmed speakers include:
Former FDA Officials:
· Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
· Elaine Messa, Executive Vice President of the Medical Device Practice, NSF Health Sciences; former Director of the Los Angeles District, FDA
· David Elder, Vice President of Strategic Compliance Services, PAREXEL Consulting; former Director of the Office of Enforcement, ORA, FDA
· Vicky Stoakes, President, IntegRx, Inc.; former FDA chemist, ACNA and investigator, Atlanta District Office Drug Cadre
· Joseph Famiglietti, Senior Consultant, EAS Consulting Group; former investigator and compliance officer, New York District, FDA
· Len Valenti, Senior Consultant, EAS Consulting Group; former International Affairs Policy Analyst, Office of the Commissioner, FDA
Top Industry Professionals:
· John Avellanet, Managing Director and Principal, Cerulean Associates LLC, (Conference Chairperson, Drugs & Biologics Track Moderator)
· Julie Larsen, Senior Partner, Director Inspection Readiness Services, BioTeknica, (Medical Devices Track Moderator)
· Connie Hoy, Senior VP of Regulatory Affairs, Cynosure
· Dr. Patrick Brady, Deputy Vice President of Scientific and Regulatory Affairs, PhRMA
· Dr. Dave Gallup, Principal, Training and Communications Group and GMPTraining.com
· John (Jack) Garvey, Principal/CEO, Compliance Architects LLC
· Reem Malki, Vice President, Global Quality Operations, Mylan
· Máiréad Goetz, Head of Compliance , Group Compliance and Audit, Group Quality Assurance, Novartis Pharmaceuticals
· Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA
· Sandra Omrod, Global Quality Manager, Quality Standards & Compliance, AstraZeneca
· Kevin Roberson, Director, CGMP Quality Assurance, ABC Laboratories, Inc.
· Marie McDonald, Senior Director, Quality & Compliance Consulting, Quintiles
· And many more
The 9th Annual FDA Inspections Summit will address some of the toughest challenges facing drug and device company executives today and showcase solutions that work. Through more than a dozen featured speaker sessions and panels, and two in-depth pre-conference workshops, speakers will help provide innovative solutions to a wide range of critical topics, including understanding FDA’s Quality Metrics Initiative, the latest on the FDA’s re-organization of the inspectional corps, a day in the life of an investigator — how inspectors prepare and approach assigned inspections, how to treat investigators when they are in the facility, best practices in FDA 483 and warning letter management and recovery, flawless FDA inspection handling and response and no more 483s — QSIT secrets to assure clean inspections.
Can’t make it to the 9th Annual FDA Inspections Summit? Not everyone can travel to the 9th Annual FDA Inspections Summit, so it will be streamed live. It's a great way to see sessions as they happen. Registration is quick and accessing the live sessions is as simple as clicking the mouse.
Benefits include:
· The live stream is available from a computer or mobile device.
· Watch the live streaming video of the presenter and view the presentation materials in real-time.
· Easily download presentation materials and any other supporting documents provided.
· Ask questions of the speakers during the live conference from home, office or on the go with a mobile device.
· Bonus: A streaming video registration includes six month access to archived session recordings after the conference.
Time is running out and seating is limited. Register today at www.fdanews.com/InspectionsSummitPR2.
Conference Details:
9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD
www.fdanews.com/InspectionsSummitPR2
Tuition:
Pre-Conference Only: $597
Complete Summit $1,997
Additional pricing options are available online.
Easy Ways to Register:
Online: www.fdanews.com/InspectionsSummitPR2
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
FDAnews is pleased to announce the addition of Phillip Pontikos, Medical Device National Expert within the Office of Regulatory Affairs (ORA) of the FDA. Mr. Pontikos will be presenting two sessions at the 9th Annual FDA Inspections Summit taking place October 22-24, 2014, at the Doubletree Bethesda Hotel in Bethesda, MD.
Mr. Pontikos will be featured in the following sessions:
· A Day in the Life of FDA’s Field Investigators — Current and Former Field Investigators Explain What They Look For and Why and What’s on the Horizon: Panel Discussion
· Most 483 Observations Can Be Traced Back to Training — Deploying the Newest and Most Successful “Learning” Methods to Curb 483s: Panel Discussion
Joining Mr. Pontikos will be an elite group of his colleagues from FDA’s Centers, Directorates and ORA. These include:
· Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office Of The Center Director, CDRH, FDA
· Dr. Neil Stiber, Operations Research Analyst, Office Of Strategic Programs, CDER, FDA
· Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
· Marc Neubauer, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
· Capt. Cynthia Harris, SRO, Medical Device/Bioresearch Monitor, ORA, FDA, Baltimore District
The 9th Annual FDA Inspections Summit will be an unprecedented gathering of the nation’s most influential and innovative thought leaders in quality, compliance and inspectional readiness. Plus, they are the practitioners, policy makers, and legal advisors who are best equipped to move inspections into 2015 and beyond.
Time is running out and seating is limited. Register today at www.fdanews.com/InspectionsSummitPR2.
Additional confirmed speakers include:
Former FDA Officials:
· Steve Niedelman, Lead Quality Systems and Compliance Consultant, King and Spalding, former FDA Deputy Associate Commissioner for Regulatory Operations
· Elaine Messa, Executive Vice President of the Medical Device Practice, NSF Health Sciences; former Director of the Los Angeles District, FDA
· David Elder, Vice President of Strategic Compliance Services, PAREXEL Consulting; former Director of the Office of Enforcement, ORA, FDA
· Vicky Stoakes, President, IntegRx, Inc.; former FDA chemist, ACNA and investigator, Atlanta District Office Drug Cadre
· Joseph Famiglietti, Senior Consultant, EAS Consulting Group; former investigator and compliance officer, New York District, FDA
· Len Valenti, Senior Consultant, EAS Consulting Group; former International Affairs Policy Analyst, Office of the Commissioner, FDA
Top Industry Professionals:
· John Avellanet, Managing Director and Principal, Cerulean Associates LLC, (Conference Chairperson, Drugs & Biologics Track Moderator)
· Julie Larsen, Senior Partner, Director Inspection Readiness Services, BioTeknica, (Medical Devices Track Moderator)
· Connie Hoy, Senior VP of Regulatory Affairs, Cynosure
· Dr. Patrick Brady, Deputy Vice President of Scientific and Regulatory Affairs, PhRMA
· Dr. Dave Gallup, Principal, Training and Communications Group and GMPTraining.com
· John (Jack) Garvey, Principal/CEO, Compliance Architects LLC
· Reem Malki, Vice President, Global Quality Operations, Mylan
· Máiréad Goetz, Head of Compliance , Group Compliance and Audit, Group Quality Assurance, Novartis Pharmaceuticals
· Denyse Baker, Senior Advisor, Scientific and Regulatory Affairs, PDA
· Sandra Omrod, Global Quality Manager, Quality Standards & Compliance, AstraZeneca
· Kevin Roberson, Director, CGMP Quality Assurance, ABC Laboratories, Inc.
· Marie McDonald, Senior Director, Quality & Compliance Consulting, Quintiles
· And many more
The 9th Annual FDA Inspections Summit will address some of the toughest challenges facing drug and device company executives today and showcase solutions that work. Through more than a dozen featured speaker sessions and panels, and two in-depth pre-conference workshops, speakers will help provide innovative solutions to a wide range of critical topics, including understanding FDA’s Quality Metrics Initiative, the latest on the FDA’s re-organization of the inspectional corps, a day in the life of an investigator — how inspectors prepare and approach assigned inspections, how to treat investigators when they are in the facility, best practices in FDA 483 and warning letter management and recovery, flawless FDA inspection handling and response and no more 483s — QSIT secrets to assure clean inspections.
Can’t make it to the 9th Annual FDA Inspections Summit? Not everyone can travel to the 9th Annual FDA Inspections Summit, so it will be streamed live. It's a great way to see sessions as they happen. Registration is quick and accessing the live sessions is as simple as clicking the mouse.
Benefits include:
· The live stream is available from a computer or mobile device.
· Watch the live streaming video of the presenter and view the presentation materials in real-time.
· Easily download presentation materials and any other supporting documents provided.
· Ask questions of the speakers during the live conference from home, office or on the go with a mobile device.
· Bonus: A streaming video registration includes six month access to archived session recordings after the conference.
Time is running out and seating is limited. Register today at www.fdanews.com/InspectionsSummitPR2.
Conference Details:
9th Annual FDA Inspections Summit
**Presented by FDAnews**
Oct. 22-24, 2014 – Bethesda, MD
www.fdanews.com/InspectionsSummitPR2
Tuition:
Pre-Conference Only: $597
Complete Summit $1,997
Additional pricing options are available online.
Easy Ways to Register:
Online: www.fdanews.com/InspectionsSummitPR2
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
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FDAnews
Michelle Butler
703-538-7600
www.fdanews.com
Michelle Butler
703-538-7600
www.fdanews.com
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