5th Clinical Quality Signals, RCA and CAPA
5th Signal Detection, Root Cause Analysis and CAPA Summit
- 제5회 임상시험 신호 탐지, RCA 및 CAPA 서밋 -
- 미국 버지니아주 알링턴
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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

제5회 Signal Detection, Root Cause Analysis and CAPA Summit은 임상시험의 논컴플라이언스(non-compliance) 식별, 근본 원인 이해, 적절한 시정조치 및 예방조치에 의한 대응에 초점을 맞춘 유일한 포럼으로, 규모와 종류가 다양한 기업에서 임상시험 품질 및 업무 관리에 종사하고 있는 관계자들이 한자리에 모여 의견을 교환하고 경험을 소개하는 장소입니다.

참가를 권유하는 5가지주요 이유

  1. 시정조치와 예방조치(CAPA) 도입, 검증, 타당성 확인을 위한 툴 관련 문제와 유의사항 파악
  2. 조사를 위한 준비작업 시행, 조사 결과를 다룰 경우의 작업 방침을 결정하기 위한 방법에 대해 논의
  3. 대기업과 소기업에서의 근본 원인 분석(RCA)과 CAPA 도입 방법에 대해 논의
  4. 제약회사와 의료기기 제조업체에서 부적합 원인이 되는 문제를 방지하기 위한 프로액티브 위기 관리에 관한 강연 청취
  5. CAPA 도입 후 벤더와 기술 관리 및 전신성 및 비전신성 문제에 대처하는 방법 검토

지난 컨퍼런스 참가자 소감

「시정조치 및 예방조치(CAPA)와 근본 원인 분석(RCA)에 대한 업계 접근법의 진화에 따라 이 포럼에서 채택하는 토픽도 계속 진화하고 있다는 점이 좋다고 생각합니다.」 – Janssen

「전문가로부터 다양한 정보를 얻고, 베스트 프랙티스에 대한 의견을 교환하는 등 유익한 시간을 보냈습니다.」 – MedTrials

「지금까지 참가한 것 중에서 최고의 컨퍼런스 중 하나입니다.」 – Pfizer

「기대 이상의 우수한 컨퍼런스였습니다.」 – Polaris Compliance Consultants

「본인이 시작부터 제대로 작업하고 있다는 점을 확인할 수 있었고, 업무를 개선하여 새로운 레벨로 이동시키는 방안에 대한 좋은 아이디어를 얻을 수 있었습니다.」 – Kforce

「CAPA의 컨셉과 시스템, 사례에 대한 자세한 설명이 좋았습니다.」 – Genzyme

「이런 종류의 이벤트에 처음 참가하는 사람들에게 매우 유익한 모임이었습니다.」 – Boston Scientific

「유익한 정보와 연사에 매우 만족합니다. 다른 분들에게도 권하고 싶습니다.」 – P&G

「처음 참가했는데 매우 우수한 컨퍼런스였습니다. 연사도 컴플라이언스와 업무 개선에 열정적인 분들이었습니다.」 – Regeneron

「매우 유익한 컨퍼런스였습니다. 여기에서 얻은 귀중한 정보를 동료들에게 소개할 수 있다는 점이 매우 흥분됩니다.」 – GSK


참가 대상자

제약회사 및 바이오테크놀러지 기업, 의료기기 제조업체, 의약품 개발업무 수탁기관(CRO), 임상시험 관련 서비스 프로바이더 등에서 다음과 같은 업무에 종사하고 있는 최고 책임자, VP, 디렉터, 매니저, 팀리더급 임원

  • 임상시험 품질 보증/관리/컴플라이언스
  • 연구개발 컴플라이언스
  • 임상시험관리기준(GCP) 컴플라이언스
  • 임상시험 감사
  • 품질 시스템/프로세스
  • 규제 문제
  • 임상 개발/업무
  • 품질 훈련
  • 데이터 관리/분석
  • 임상시험 감시
  • 시판 후 컴플라이언스
  • 밸리데이션
  • CMC
  • 의약품 안전성 감시에 의한 품질 보증
  • 지속적 개선

또한 다음과 같은 업무에 종사하는 분들에게도 유익한 컨퍼런스입니다.:

  • 데이터 관리 솔루션 및 컴퓨터 소프트웨어 벤더
  • 품질관리 컨설턴트
  • 임상시험 시설

아젠다



첫째날

2015년 1월 22일(목)

8:45AM – 9:00AM

등록 및 아침식사

9:00AM – 9:15AM

의장 개회사

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

9:15AM – 10:00AM

전신성과 비전신성 문제 및 CAPA 시행

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

10:00AM – 10:45AM

CAPA 도입 후 벤더 관리와 기술 관리의 중요성

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

10:45AM – 11:15 AM

휴식시간

11:15 AM – 12:00PM

사례 연구:CAPA 관리 프로그램과 데이터베이스 도입으로 연결되는 CAPA 구상에 대한 성공적인 코퍼레이트 바이인(Corporate Buy-in)

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

12:00PM – 1:15PM

오찬회

1:15PM – 2:00PM
패널 세션

CAPA 의 검증과 타당성 확인을 위한 툴, 문제, 유의사항

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

근본 원인 분석(RCA)과 효과적인 CAPA 시스템

Regi Thomas, Principal Quality Specialist, ROCHE MOLECULAR SYSTEMS

2:45PM – 3:15PM

휴식시간

3:15PM – 4:00PM

CAPA 시스템을 이용한 리액티브 품질관리에서 프로액티브 품질관리로의 이동

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

4:00PM – 4:45PM

CAPA 시스템 도입과 문화 변혁 추진, CAPA 프로세스를 이용한 지속적 개선 실현

Paula Parsons, Compliance Manager, AMGEN INC.

4:45PM – 5:30PM

패널 세션

위기 관리 전략, RCA 및 CAPA 프로세스 평가

패널리스트:
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

클로징 멘트와 첫째날 정리



둘째날

2015년 1월 23일(금)

8:00AM – 8:45AM

아침식사

8:45AM –

의장 모두발언

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

 

임상시험 트랙

9:00AM – 9:45 AM
패널 세션


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

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

CAPA 도입 후 감사와 검사 준비 체제

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

소기업과 대기업의 RCA와 CAPA 도입

10:30AM – 11:00AM

휴식시간

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

임상시험관리기준(GCP)에서 CAPA 시스템의 탐색적 연구

11:45AM – 12:30PM
패널 세션

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

리스크 기반 모니터링과 임상시험 시설에 대한 미지의 영향

12:30PM – 1:45PM

오찬회

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

의사 주도 임상시험과 CAPA의 발전

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

부적합 원인이 되는 문제를 방지하기 위한 프로액티브 위기 관리와 CAPA 이용


시판 후 트랙

9:00AM – 9:45AM
패널 세션

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

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

효과가 높은 시판 후 종합 CAPA 관리 시스템의 실현을 위한 제약업계의 베스트 프랙티스

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

품질 데이터 평가와 CAPA 조사의 우선순위 결정에 대한 리스크 기반 어프로치 활용

10:30AM – 11:00AM

휴식시간

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

의료기기 업계의 CAPA 발전

11:45AM – 12:30PM
패널 세션

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

실패에 관한 효과적인 조사 시행 - 증상이 아니라 진정한 근본 원인에 대처

12:30PM – 1:45PM

오찬회

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

CAPA를 통합한 시판 후 품질관리 시스템에 의한 잠재적인 부적합 원인 배제

2:30PM – 3:15PM

의료기기의 리스크 평가와 시판 후 조사


 

3:15PM – 3:30PM

폐회사, 서밋 폐막

* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.



교수진


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.


스폰서 & 전시기업


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

파트너

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


개최지

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

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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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