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 Type II errors.
Webinar Pack Pack of TEN: Best Selling Webinars by GlobalCompliancePanel Actual Price: $2950.00 Your Price: $1095.00 Buy Now Using Statistics to Determine Sample Size This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Instructors: 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 application. 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 Technologies 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 Click here to buy the webinar pack It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel 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. 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