Preparing for FDA

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					Live Webinar on : Preparing for FDA Inspection and Handling the Consequences Thursday,
May 31, 2012 duration : 12:00 to 01:30 PM EST


                                        We will review the latest inspection statistics released
                                        from FDA, discuss how to prepare for an FDA
Get 15 % Discount as an early bird
                                        Inspection, discuss how to repsond to an FDA
registration. Use Promo Key :
                                        Inspection and discuss the possible outcomes of an
                                        FDA Inspection that has resulted in significant findings
                                        and/or citations.
Who will benefit

Clinical Research managers              Why should you Attend :

Project Managers                        · 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 Research Associates
                                        Clinical Investigator Inspections, 6% or ~ 15 of the IRB
                                        Inspections and 12% or ~ 15 of the Sponsor/Monitor
Monitors                                Inspections were categorized as "Official Action
                                        Indicated". 45% of Clinical Investigator, 50% of IRB
Quality Assurance Professionals         and 38% of Sponsor/Monitor Inspections were
                                        categorized as "Voluntary Action Indicated" being
Research coordinators                   required. Because FDA Inspections are part of doing
                                        business and getting products to market, Clinical
Clinical investigators                  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

                                        Areas Covered in the Session:
                                    - Preparing for an FDA Inspection.

                                    - Discussion on receiving and responding to 483s and
purchase formats                    warning letters.

    $189 One Dial In - One
                                    - Discussion on what actions the FDA can take over and
     $249 One Dial In - Unlimited   beyond issuing a 483 or Warning Letter.
attendance (To be arranged in a
Conference room/Meeting room.
Note : Only One Dial In Allowed)

    $289 On Demand (Recording
available within 48 hrs after the   About Speaker:
completion of the webinar)
                                    Lee Truax-Bellows has an extensive background in the
                                    pharmaceutical and medical device industries, having
    $349 Get Training CD            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
    More Trainings                  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
                        Compliance2go |
                        Phone : 877.782.4696 | Fax : 281-971-0286
                          Email :

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