5th Signal Detection, Root Cause Analysis and CAPA Summit
5th Signal Detection, Root Cause Analysis and CAPA Summit
- 第5回臨床試験品質毀損事象の兆候とRCAおよびCAPAに関する学会 -
- 米国バージニア州、アーリントン
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5th Signal Detection, Root Cause Analysis and CAPA Summit

January 21st - 22nd / Arlington

Identifying clinical non-compliance, conducting the root cause analysis, and responding with appropriate corrective and preventive actions


5th Signal Detection, Root Cause Analysis and CAPA Summit

第5回Signal Detection, Root Cause Analysis and CAPA Summitは、臨床試験におけるノンコンプライアンス(服薬不遵守)の特定、その根本原因の理解、適切な是正措置や予防措置による対応に焦点を絞り込んだ唯一のフォーラムであり、規模やタイプの異なるさまざまな企業で臨床試験の品質や業務の管理に携わっておられる方々が一堂に会して意見を交換し、経験を披露し合う場となっています。

参加をお勧めする5つの主な理由

  1. 是正措置と予防措置(CAPA)の導入、検証、妥当性確認のためのツールにまつわる課題や留意すべき点について学ぶことができます
  2. 調査のための準備作業を行い、調査結果を扱う場合の作業方針を決定するための方法について議論することができます
  3. 大企業と小企業で根本原因の分析(RCA)とCAPAの手法を導入する方法について議論することができます
  4. 製薬会社や医療機器メーカーが不適合の原因となるような問題を防止するためのプロアクティブな危機管理に関する講演を聞くことができます
  5. CAPA導入後のベンダーと技術の管理、および全身性および非全身性の問題に対処する方法を検討することができます

前回までの学会に参加された方々の声

「是正措置と予防措置(CAPA)や根本原因の分析(RCA)に対する業界のアプローチが進化するのに伴って、このフォーラムで取り上げるトピックも進化し続けている点が素晴らしいと思います」 – Janssen

「専門家からさまざまなことを学び、ベストプラクティスをめぐって意見を交換するなど、大変有意義な時間を過ごすことができました」 – MedTrials

「これまでに参加したなかで最良の学会の1つです」 – Pfizer

「期待を上回る素晴らしい学会でした」 – Polaris Compliance Consultants

「自分が当初から正しい対応をしていたという点が確認でき、業務を改善して新たなレベルへと移行させる方策についても優れた着想を得ることができました」 – Kforce

「CAPAの考え方やシステム、事例についての詳しい解説が有益でした」 – Genzyme

「この種のイベントに初めて参加する者にとって大変良い学会でした」 – Boston Scientific

「有益な情報と講演者に大変満足しています。他の人にも勧めたいと思います」 – P&G

「はじめて参加しましたが、大変良い学会でした。講演者も、コンプライアンスと業務の改善に情熱を持って取り組んでおられる方々でした」 – Regeneron

「大変有意義な学会でした。貴重な情報を持ち帰って、同僚たちに紹介できるのはとても喜ばしいことです」 – GSK


参加をお勧めする方々

製薬会社やバイオテクノロジー企業、医療機器メーカー、医薬品開発業務受託機関(CRO)、臨床試験関連のサービスプロバイダーなどで、以下のような業務に携わっている最高責任者、バイスプレジデント、ディレクター、マネジャー、チームリーダーレベルの幹部

  • 臨床試験品質保証/管理/コンプライアンス
  • 研究開発のコンプライアンス
  • 臨床試験実施基準(GCP)のコンプライアンス
  • 臨床試験監査
  • 品質保持システム/プロセス
  • 規制問題
  • 臨床開発/業務
  • 品質保持訓練
  • データ管理/分析
  • 臨床試験監視
  • 市販後コンプライアンス
  • 妥当性確認
  • CMC
  • 医薬品安全性監視による品質保証
  • 継続的改善

また、以下のような業務に携わっておられる方々にとっても有益な学会です:

  • データ管理ソリューションやコンピューターソフトウェアのベンダー
  • 品質管理コンサルタント
  • 臨床試験実施施設

アジェンダ



1日目

2015年1月22日(木)

8:45AM – 9:00AM

登録手続きと朝食

9:00AM – 9:15AM

議長の開会挨拶

Kevin Wilson, Manager, Global Medical Quality Systems, ELI LILLY

9:15AM – 10:00AM

全身性と非全身性の問題およびCAPAの実施

Federico Feldstein, J.D., Vice President, Medical Regulatory Compliance, PFIZER INC.

10:00AM – 10:45AM

CAPA導入後のベンダー管理と技術管理の重要性

Venessa Galate, Director, Quality Processes Liaisons, JANSSEN RESEARCH & DEVELOPMENT, J&J

10:45AM – 11:15 AM

休憩

11:15 AM – 12:00PM

ケーススタディ:CAPA管理プログラムとデータベースの導入につながるCAPA構想への全社的な取り組みの成功例

Timothy Urschel, Director, Quality Assurance & Regulatory Affairs, ASUBIO PHARMACEUTICALS, DAIICHI SANKYO GROUP

12:00PM – 1:15PM

昼食会

1:15PM – 2:00PM
パネルセッション

CAPAの検証と妥当性確認のためのツール、課題、留意すべき点

PANELISTS:
Linda Sullivan
, Chief Operating Officer, METRICS CHAMPION CONSORTIUM

Pam Strobel, Quality Risk Management Portfolio Lead, PFIZER, INC.
Venessa Galate, Director, Quality Processes Liaisons, JANSSEN RESEARCH & DEVELOPMENT, J&J
Federico Feldstein, J.D., Vice President, Medical Regulatory Compliance, PFIZER INC.

2:00PM – 2:45PM

根本原因の分析(RCA)と効果的なCAPAシステム

Regi Thomas, Principal Quality Specialist, ROCHE MOLECULAR SYSTEMS

2:45PM – 3:15PM

休憩

3:15PM – 4:00PM

CAPAシステムを利用したリアクティブな品質管理からプロアクティブな品質管理への移行

Kevin Wilson, Manager, Global Medical Quality Systems, ELI LILLY

4:00PM – 4:45PM

CAPAシステムの導入と文化の変革を推進し、CAPAプロセスを利用して継続的改善を実現していくための取り組み

Paula Parsons, Compliance Manager, AMGEN INC.

4:45PM – 5:30PM

パネルセッション

危機管理戦略、RCAおよびCAPAプロセスの評価

パネリスト:
Chris Hoag
, Director of Global CAPA and Quality eSystems, STRYKER

Dwayne Brazelton, Director, Clinical Quality Assurance, MACROGENICS, INC.
Glenda Abbott, Director, Quality Assurance, ABBOTT DIAGNOSTICS

5:30PM – 5:30PM

締めくくりの言葉と1日目の総括



2日目

2015年1月23日(金)

8:00AM – 8:45AM

朝食

8:45AM –

議長の冒頭発言

Kevin Wilson, Manager, Global Medical Quality Systems, ELI LILLY

 

臨床試験部会

9:00AM – 9:45 AM
パネルセッション


PANELISTS:
Pearl Boakye
, Head, Compliance Management, BAYER HEALTHCARE

Sunil Kotecha, Corporate Audit, PFIZER, INC.
Cheri Wilczek, President, CLINAUDITS, LLC.

CAPA導入後の監査と検査の準備体制

9:45 AM – 10:30AM
Susan MacKay, Manager, CAPA Management for Global Clinical Quality Auditing, NOVARTIS VACCINES & DIAGNOSTICS

小企業と大企業におけるRCAとCAPAの導入

10:30AM – 11:00AM

休憩

11:00AM – 11:45AM
Diogo Araujo, Global CAPA Manager, BAYER HEALTHCARE

臨床試験実施基準(GCP)におけるCAPAシステムの探索的研究

11:45AM – 12:30PM
パネルセッション

Christine Pierre, President, SOCIETY FOR CLINICAL RESEARCH SITES (SCRS)
Dawn Niccum, Quality Manager, ENDOCYTE

リスクに基づくモニタリングと治験実施施設に対する未知の影響

12:30PM – 1:45PM

昼食会

1:45PM – 2:30PM
Stephanie deRijke, Director, Clinical Trials Audit and Compliance, EMORY UNIVERSITY

医師主導治験とCAPAの発展

2:30PM – 3:15PM
Pam Strobel, Quality Risk Management Portfolio Lead, PFIZER, INC.

不適合の原因となる問題を防止するためのプロアクティブな危機管理とCAPAの利用


市販後部会

9:00AM – 9:45AM
パネルセッション

PANELISTS:
Chris Hoag
, Director of Global CAPA and Quality eSystems, STRYKER

Karl Vahey, Senior Director of Global Quality Compliance and Audit, COVIDIEN

効果の高い市販後総合CAPA管理システムの実現に向けた製薬業界のベストプラクティス

9:45AM – 10:30AM
Glenda Abbott, Director, Quality Assurance, ABBOTT DIAGNOSTICS

品質データの評価とCAPA調査の優先順位設定に対するリスクベースアプローチの活用

10:30AM – 11:00AM

休憩

11:00AM – 11:45AM
Teri Savage, Principal Quality Improvement Analyst, MEDTRONIC

医療機器業界におけるCAPAの発展

11:45AM – 12:30PM
パネルセッション

Karl Vahey, Senior Director of Global Quality Compliance and Audit, COVIDIEN

不具合に関する効果的な調査の実施−症状ではなく真の根本原因への対応

12:30PM – 1:45PM

昼食会

1:45PM – 2:30PM
Denise Nazario, Global CAPA Manager, STRYKER

CAPAを統合した市販後品質管理システムによる潜在的な不適合の原因排除

2:30PM – 3:15PM

医療機器のリスク評価と市販後調査


 

3:15PM – 3:30PM

閉会の挨拶、学会閉幕

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。



教授陣


Glenda Abbott, Director, Quality Assurance, ABBOTT DIAGNOSTICS


Diogo Araujo, Global CAPA Manager, BAYER HEALTHCARE


Pearl Boakye, Head, Compliance Management, BAYER HEALTHCARE


Dwayne Brazelton, Director, Clinical Quality Assurance, Clinical Quality Standards, MACROGENICS, INC.

Dwayne Brazelton has more than 24 years experience in the pharmaceutical industry.  He serves as the Director of Clinical Quality Assurance at MacroGenics, Inc.  In this role Dwayne is responsible for the design and execution of all company GCP quality assurance processes and initiatives, as well as ensuring their effectiveness in satisfying the quality and compliance objectives of this novel biotechnology company.

Prior to working at MacroGenics, Dwayne served as the Director, Clinical Quality and Compliance at Covidien.  In this role, he built a new quality assurance organization capable of supporting the GLP, PV and GCP needs of the Covidien Pharmaceutical’s R&D organization.

Dwayne’s experience also includes more than 16 years of non-clinical and clinical quality assurance experience with Pfizer.  He began his GCP career as a clinical project auditor, serving as a GCP and quality advisor, as well as performing domestic and international clinical audits.  Those audits included investigator site, in-licensing, for cause, regional office, vendor, document, as well as internal systems audits.  He assumed roles of increasing responsibility before managing a team of clinical quality assurance professionals.  In this role he ensured the development of appropriate project-level risk assessments, audit plans and the effective delivery of the portfolio of QA activities across more than 20 major clinical projects/products.  He also provided a leadership role in multiple FDA sponsor-monitor inspections.

Dwayne holds a B.S. degree in Biology from the University of Evansville.


Stephanie deRijke, Director, Clinical Trials Audit and Compliance, EMORY UNIVERSITY


Federico Feldstein, J.D., Vice President, Medical Regulatory Compliance, PFIZER INC.


Venessa Galate, Director, Quality Processes Liaisons, JANSSEN RESEARCH & DEVELOPMENT, J&J


Chris Hoag, Director of Global CAPA and Quality eSystems, STRYKER


Sunil Kotecha, Corporate Audit, PFIZER, INC.


Susan MacKay, Manager, CAPA Management for Global Clinical Quality Auditing, NOVARTIS VACCINES & DIAGNOSTICS


Denise Nazario, Global CAPA Manager, STRYKER


Dawn Niccum, Quality Manager, ENDOCYTE


Paula Parsons, Compliance Manager, AMGEN INC.


Christine Pierre, President, SOCIETY FOR CLINICAL RESEARCH SITES (SCRS)


Teri Savage, Principal Quality Improvement Analyst, MEDTRONIC


Pam Strobel, Quality Risk Management Portfolio Lead, PFIZER, INC.


Linda Sullivan, Chief Operating Officer, METRICS CHAMPION CONSORTIUM

Linda Sullivan is Chief Operating Officer at the Metrics Champion Consortium (MCC), an industry association dedicated to the development and support of clinical trial performance metrics within the biotechnology, pharmaceutical and medical device industries. Her duties include direct membership/dues-based services and ongoing operations of the company.

She has been a featured speaker at numerous industry meetings covering a wide array of topics, including Clinical Operations, Clinical Outsourcing, Lean Sigma and Kaizen in the Life Sciences R&D, Performance Metrics and Benchmarking, Risk-Based Approaches to Quality Management, Quality Oversight of Clinical Trial Vendors, e-Clinical Systems and Project Management.  Additionally, Ms. Sullivan has published quality-by-design and performance metric articles in peer-reviewed industry journals.

Prior to the MCC, she was a management consultant for several global consulting companies.

Ms. Sullivan received a B.S. in Biology from Trinity College. She earned an MBA from The Amos Tuck School of Business Administration at Dartmouth College, where she was named an Edward Tuck Scholar.


Regi Thomas, Principal Quality Specialist, ROCHE MOLECULAR SYSTEMS


Timothy Urschel, Director, Quality Assurance & Regulatory Affairs, ASUBIO PHARMACEUTICALS, DAIICHI SANKYO GROUP


Karl Vahey, Senior Director of Global Quality Compliance and Audit, COVIDIEN


Cheri Wilczek, President, CLINAUDITS, LLC

Cheri A. Wilczek, M.S., B.S., is the founder and President of ClinAudits, LLC, a recognized leader and independent, niche provider of domestic and international Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) auditing services and has managed its growth since the company’s inception in 1994.  She has more than 33 years in the regulated pharmaceutical industry. ClinAudits assists clients in the pharmaceutical, biotechnology, tissue engineering, medical device industries, OTC, RX, gene therapy, and medical universities and institutions, and is focused on meeting end-to-end FDA and other governmental authority compliance requirements around the world.

The company operates strictly within the regulations/guidelines set forth by the FDA and other governmental authorities; regulations/guidelines designed to bring products to market which have demonstrated adherence to exacting standards in terms of manufacturing and production, field-proven efficacy and patient safety. Because we do not conduct or manage clinical trials (e.g., IVRS and EDC processes), ClinAudits is well positioned to emphasize our 100% objectivity and independence across a comprehensive portfolio of critical services.

ClinAudits is proud to have attained a Women-Owned Business Enterprise Certification.

Cheri obtained her Bachelor of Science degree from the University of Delaware and her Master of Science in Genetics from the University of Maryland.

Prior to founding ClinAudits, Cheri had prior positions with The Upjohn Company and Hoffmann La Roche.


Kevin Wilson, Manager, Global Medical Quality Systems, ELI LILLY

Kevin Wilson has been helping to design, implement and train on Quality systems since 2006.  Kevin has specialized in the design and deployment of root cause analysis and corrective and preventive action (CAPA) processes.   Kevin currently acts as a manager, mentor and coach to a team of root cause investigators and quality management subject matter experts who are focused on risk mitigation and continuous improvement.  Kevin’s CAPA system experience has been brought to the Pharmaceutical and Device product lifecycle from Research and Development through Clinical Development to Manufacturing and Post Market Surveillance.  The CAPA system has been able to strategically integrate multiple signals including but not limited to deviations, complaints, audits and inspections, changes, and non-conformities.

Kevin has a customer-focused mentality, knowing that any Quality system is only as good as the people who use the system.  Kevin has been developing not just Quality systems that are easy to use, but building the support structure and tools to enable success.  For any Quality system to be ultimately successful, the correct behaviors must be encouraged and rewarded.

Kevin is a graduate of DePauw University, and an ASQ certified Six Sigma Green Belt.


スポンサー & 出展者


ClinAudits

ClinAudits is a truly independent organization providing auditing and compliance consulting services domestically and throughout the world. Continuing for over 20 years, clients receive customized services requiring expertise and direct experience with GCP, GTP, GMP, GLP, REMs, tobacco, and animal health. All activities are coordinated centrally from our offices in northern New Jersey. Regionally-based, senior-level auditors conduct on-site or remote audits and other compliance services relating to pre-clinical research through Phase 4 development programs, and onto commercialization of products. Be it a need to address a single, immediate QA event or to serve the complete QA function, ClinAudits’ approach is to clarify the specific need and then develop and implement an effective plan, all while delivering exceptional quality, service, and value.

Website: http://www.clinaudits.com

パートナー

Bentham Science

Bentham Science Publishers is a major STM journal publisher of 116 titles and 200 plus open access journals and print/online book series (Bentham eBooks). Bentham Science answers the information needs of the pharmaceutical and biomedical research community. Leading journals include Current Drug Metabolism (Impact Factor 5.113) and Current Medicinal Chemistry (Impact Factor 4.859): 

FREE online journals and information: www.benthamscience.com
Subscribe, Consortia, discounted global licenses and trials: marketing@benthamscience.org
To know more about our publications please visit www.benthamscience.com

Website:http://www.benthamscience.com/

Cutting Edge Info

Cutting Edge Information can address all aspects of your clinical development with our comprehensive data gathered from across the industry and around the globe. Whether your team is a small group focused on its first projects or a larger organization running hundreds of trials, our real-world findings tackle thorny issues and boost output with industry-leading practices. Dive into years of research to explore everything from detailed clinical trial operations benchmarks and patient recruitment to emerging markets site selection and investigator-initiated studies.

Website:http://www.cuttingedgeinfo.com/research/clinical-development/

MarketsandMarkets

MarketsandMarkets is a global market research organization which is also into advisory and consulting services. We publish strategically analyzed market research reports and serve as a business intelligence partner to Fortune 500 companies across the world.

Using effective technology to automate management of large and complex data for forecasts, we provide global analysis, data and insights through unique & in-depth research, serving multi-client reports, company profiles, databases, and custom research services. These intelligence databases comprises of about 60000 reports a year, which forms one of the world’s largest intelligence resources. M&M plans to launch industry-wise and country wise market tracker for all existing research verticals.

Website:http://www.marketsandmarkets.com/

The Metrics Champion Consortium (MCC) is an industry organization comprised of biotechnology, pharmaceutical, clinical research sites and service provider organizations. Our mission is to help sponsor, site and service provider organizations involved in the pharmaceutical, biotechnology and medical device industries improve their overall clinical trial development processes through the utilization of MCC standardized clinical trial performance metrics (time, cost & quality) by supporting the ongoing collaborative development of standardized performance metrics and process improvement tools, encouraging the continuous implementation of the metrics and tools among MCC members, providing a collaborative learning environment for members to share best practices, discuss challenges and industry trends and offering live and online educational opportunities to support the use of performance metrics and tools in member organizations.

For additional information about the MCC, please visit www.metricschampion.org

Website:www.metricschampion.org

pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing together healthcare through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.

Visit pharmaphorum today to share, discuss and debate.
www.pharmaphorum.com

Website:http://www.pharmaphorum.com

PharmCast

www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer’s Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals.

Website:http://www.PharmCast.com

PM360

PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal’s targeted and insightful editorial focuses on issues that directly impact critical decision making, including: planning and implementation of cutting edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the ’360′ in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Website:http://www.pm360online.com/

Technology Networks

Technology Networks has been established for over 10 years and is now the leading provider of free information services for life science professionals. This includes news, events, posters, videos, webcasts, application notes, new products, a literature search engine and product directories. The information is specifically tailored to over 30 individual communities with specific interests, all of which can be accessed through TechnologyNetworks.com.

Website:http://www.TechnologyNetworks.com


開催地

Situated just across the Potomac River from Georgetown, Key Bridge Marriott offers panoramic views of the sights and sounds of the Nation’s Capital. Our hotel near Georgetown also provides direct access to Ronald Reagan Washington National Airport and Northern Virginia roadways saving you travel time in and out of the District when visiting area corporations and government agencies. Travelers looking to take in the area’s famous landmarks, such as the Iwo Jima Memorial, Arlington National Cemetery and the National Monuments, can hop on the DC Metro system at Rosslyn station, only three blocks from our front door. Our hotel’s stylish accommodations near Georgetown, DC include an open lobby with private seating nooks and complimentary wireless Internet access. We also offer 17,000 square feet of stylish, flexible meeting space across 22 rooms, including the top-floor Capital View Ballroom, which seats up to 300 attendees and offers astonishing penthouse views.
Key Bridge Marriott
1401 Lee Highway
Arlington
VA
22209

Visit Website

地図

To make reservations call 1-800-228-9291 and request the negotiated rate for "ExL's January Meetings".

You must book your room by January 12th, 2015 to be eligible for the discounted rate. Please book your room early, as rooms available at this rate are limited.

ExL Events, Inc. is not affiliated with any third-party booking agencies, housing bureaus or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly e-mail us at info@exlevents.com.



 
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