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  • Preparing For FDA

    Загружено:

    Jay Sylvester
    22 просмотров3 страницы
    45% of clinical investigator, 50% of IRB and 38% of Sponsor / Monitor Inspections were categorized as "Voluntary Action Indicated" being required. 45% of clinical Investigator, 50% of. Sponsor / Monitor Inspections were classified as "voluntary action. In 2010, under CDRH, CDER and CBER divisions alone, FDA classified 1,097 Sponsor, site and IRB Inspections.

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    Preparing for FDA

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    45% of clinical investigator, 50% of IRB and 38% of Sponsor / Monitor Inspections were categorized as "Voluntary Action Indicated" being required. 45% of clinical Investigator, 50% of. Sponsor / Monitor Inspections were classified as "voluntary action. In 2010, under CDRH, CDER and CBER divisions alone, FDA classified 1,097 Sponsor, site and IRB Inspections.

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    22 просмотров3 страницы

    Preparing For FDA

    Загружено:

    Jay Sylvester
    45% of clinical investigator, 50% of IRB and 38% of Sponsor / Monitor Inspections were categorized as "Voluntary Action Indicated" being required. 45% of clinical Investigator, 50% of. Sponsor / Monitor Inspections were classified as "voluntary action. In 2010, under CDRH, CDER and CBER divisions alone, FDA classified 1,097 Sponsor, site and IRB Inspections.

    Авторское право:

    Attribution Non-Commercial (BY-NC)
    Скачайте в формате DOCX, PDF, TXT или читайте онлайн в Scribd
    Отметить как неприемлемый контент
    из 3

    Live Webinar on : Preparing for FDA Inspection and Handling the Consequences

    Thursday, May 31, 2012 duration : 12:00 to 13:30 PM EST

    Description

    Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15

    Who will benefit

    We will review the latest inspection statistics released from FDA, discuss how to prepare for an FDA Inspection, discuss how to repsond to an FDA Inspection and discuss the possible outcomes of an FDA Inspection that has resulted in significant findings and/or citations.

    Clinical Research managers Project Managers Clinical Research Associates Monitors Quality Assurance Professionals Research coordinators Clinical investigators
    Why should you attend In 2010 under CDRH, CDER and CBER divisions alone, FDA classified 1,097 Sponsor, Site and IRB Inspections. Of those Inspections 9% or ~ 66 of the Clinical Investigator Inspections, 6% or ~ 15 of the IRB Areas Covered in the Session:

    - Preparing for an FDA Inspection. - Discussion on receiving and responding to 483s and warning letters. - Discussion on what actions the FDA can take over and beyond issuing a 483 or Warning Letter.

    Pricing

    Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289

    Get Training CD : $499

    Inspections and 12% or ~ 15 of the Sponsor/Monitor Inspections were categorized as "Official Action Indicated". 45% of Clinical Investigator, 50% of IRB and 38% of Sponsor/Monitor Inspections were categorized as "Voluntary Action Indicated" being required. Because FDA Inspections are part of doing business and getting products to market, Clinical Investigators, Sponsors and IRBs should not only be prepared to handle an FDA Inspection but also be prepared to follow-up on findings, following the inspection.

    About Speaker

    More Trainings

    Lee Truax-Bellows has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Regulatory Consultant Monitor, Medical Communications Associate, Senior Quality Auditor, Senior Trainer and Project Manager. Lee has been involved in regulated research for over 20 plus years and specializes in product development, GCP auditing, and training on regulated research and Good Clinical Practice. Lee is a founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a clinical contract research organization (CRO) based in upstate NY. NCRA has been providing clinical research expertise in medical device, pharmaceutical, and nutraceutical development since 1994. NCRA provides full service CRO services such as monitoring, auditing, technical writing, data management, biometrics and product development consulting. Lee is active in the Association of Clinical Research Professionals (ACRP) and Society of Quality Assurance (SQA)
    .

    https://compliance2go.com/index.php?option=com_training&speakerkey=16&productKey=89
    Compliance2go | www.Compliance2go.com Phone : 877.782.4696 | Fax : 281-971-0286 Email : Support@compliance2go.com

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