Pack of TEN: Best Selling Webinars by GlobalCompliancePanel by davidross759


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    Webinar Pack
    Pack of TEN: Best Selling Webinars by GlobalCompliancePanel
    Actual Price:       $2950.00

    Your Price:         $1095.00
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    Using Statistics to Determine Sample Size
    This webinar covers the statistical methods used to calculate
    sample sizes for both attribute and variables data.

    Methods for collecting the sample will be covered.  Every sampling
    plan has risks. This webinar covers how to calculate Type I and
                                                                                          Steven Walfish
    Type II errors.
                                                                                         President, Statistical
                                                                                         Outsourcing Services
    Design History File (DHF), Device Master Record
    (DMR), Device History Record (DHR) and Technical File                     Mr. Steven Walfish is the President
    (TF) - Regulatory Documents Explained                                     of Statistical Outsourcing Services, a
    The FDA QSR and the Medical Device Directive specify certain              consulting company that provides
    documents or records that should be included in your organization's       statistical analysis and training to
    quality systems - Design History File (DHF), the Device Master            FDA regulated industries. ..more
    Record (DMR) the Device History Record (DHR), and the Technical
    File (TF).                                                                               Jeff Kasoff
                                                                                        Director of Regulatory
                                                                                        Affairs, Life-Tech, Inc
    Do you know what information should reside in a DHF, a DMR and a
    DHR? This Webinar will define, explain and clarify the different
                                                                               Jeff Kasoff, RAC, is the Director of
    records. Are you maintaining adequate DHF, DMR, DHR, and TF
                                                                              Quality at Byrne Medical, a leading
    records?                                                                  manufacturer of endoscopy
                                                                              products. ..more
    Excel Spreadsheet Validation To Eliminate 483s
    This interactive webinar provides explicit details and live                           David Nettleton
    demonstration followed by a collaborative workshop that explains                  FDA Compliance Specialist,
    how to configure and validate a GxP compliant spreadsheet
                                                                              David Nettleton, is an FDA
                                                                              Compliance Specialist for 21 CFR
    What makes this session unique is the combination of step-by-step         Part 11, HIPAA, and Computer
    instructions and the hands on workings of each participant.               System Validation. His latest book is
                                                                              "Risk Based Software Validation -
    21 CFR Part 11 - Compliance for Electronic Records                        Ten easy Steps" ..more

    and Signatures
    This webinar details the regulation and how it applies to                              Albert Cefalo
                                                                                     Regulatory Affairs Specialist,
    computerized systems.
                                                                                        Analogic Corporation

    Learn exactly what is needed to be compliant for all three primary
                                                                              Albert Cefalo, Regulatory Affairs
    areas: SOPs for the IT infrastructure, industry standards for
                                                                              Specialist, Analogic Corporation.
    software product features, and the 10-step risk-based validation          Chuck has a BS degree from
    approach.                                                                 Franklin Pierce College and a
                                                                              Graduate certificate in RA from
                                                                              Northeastern University...more
    Design Changes: When is a New 510(k) Required
    This webinar will provide an overview of the FDA guidance
    document "Deciding When to Submit a 510(k) for a Change to an                          John E Lincoln
                                                                                      Consultant, Medical device
    Existing Device".
                                                                                        and Regulatory Affairs

    Changes and The 510(k)
                                                                              John E. Lincoln is a medical device
    This webinar will examine the broad range of issues to be
                                                                              and regulatory affairs consultant. He
    considered by a company when reviewing                                    has helped companies to implement
                                                                              or modify their GMP systems and
    1) A series of minor changes or                                           procedures. ..more

    2) One major change to an existing product having an existing 510                    Dr. Ludwig Huber
    (k), for the need for a new 510(k).                                               Chief Advisor - Global FDA
                                                                                         compliance, Agilent
    Validation and Use of Excel Spreadsheets in FDA
    Regulated Environments
                                                                              Ludwig Huber, Ph.D., is Director of
    Excel Applications are widely used in laboratories, offices and
                                                                              Labcompliance and Chief Advisor for
    manufacturing e.g., for data capture, data manipulation and report        global FDA compliance at Agilent
    generation.                                                               Technologies. ..more

    Statistical Concepts of Process Validation                                              Dan OLeary
    The FDA QSR requires device manufacturers to validate processes                  President, Ombu Enterprises
    when the manufacturer cannot "fully verify the output".

                                                                              Dan is the President of Ombu
    The manufacturer must validate these processes with a "high               Enterprises, LLC, a company offering
    degree of assurance".                                                     training and execution in Operational
                                                                                   Excellence, focused on analytic skills
Verification vs. Validation in Regulated Industries                                and a systems approach to
This webinar will teach how Design Verification and Validation,                    operations management. ..more

Process Validation, Risk Management and Purchasing Controls work
                                                                                            Nancy Duarte-Lonnroth
together to produce safe medical devices.
                                                                                              Director, Quality and
                                                                                           Regulatory Affairs, Celestica
FDA's New Draft Guidance on Medical Device Changes
and the 510(k)                                                                     Nancy, is the Director of Quality &
This webinar will discuss the new draft guidance document from the                 Regulatory Affairs, Healthcare
FDA: "510(k) Device Modifications: Deciding When to Submit a 510                   responsible for global coordination of
(k) for a Change to an Existing Device", dated July 27, 2011. It will              Celestica's Healthcare Quality,
examine the broad range of issues to be considered by a company                    Regulatory and FDA compliance.
when reviewing                                                                     ..more
1) A series of minor changes or
2) one major change to an existing product having an existing 510
(k), for the need for a new 510(k).
                                                                                    Your Necessity is our Priority

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About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for

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