Preparing for FDA Inspection and Handling the Consequences by JaySylvester1


									Live Webinar on : Preparing for FDA Inspection and Handling the Consequences
Thursday, May 31, 2012 duration : 12:00 to 13:30 PM EST


                                       We will review the latest inspection statistics
                                       released from FDA, discuss how to prepare for
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registrations. Use Promo Key :         an FDA Inspection, discuss how to repsond to
 CGO15                                 an FDA Inspection and discuss the possible
                                       outcomes of an FDA Inspection that has
                                       resulted in significant findings and/or
Who will benefit                       citations.

Clinical Research managers
                                        Areas Covered in the Session:
Project Managers
                                       - Preparing for an FDA Inspection.
Clinical Research Associates
                                       - Discussion on receiving and responding to 483s
                                       and warning letters.
Quality Assurance Professionals
                                       - Discussion on what actions the FDA can take over
                                       and beyond issuing a 483 or Warning Letter.
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
Pricing                                   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
Live ( Single registration ) : $189.00    as "Voluntary Action Indicated" being required.
Group ( Max 10 Attendee): $249.00         Because FDA Inspections are part of doing business and
On Demand (Recording available):$289
                                          getting products to market, Clinical Investigators,
Get Training CD : $499                    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)


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                            Phone : 877.782.4696 | Fax : 281-971-0286
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