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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. 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 President, Statistical Outsourcing Services
Type II errors.
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. ..more
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master 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 Quality at Byrne Medical, a leading manufacturer of endoscopy products. ..more
records. Are you maintaining adequate DHF, DMR, DHR, and TF records?
Excel Spreadsheet Validation To Eliminate 483s This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
David Nettleton FDA Compliance Specialist,
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation Ten easy Steps" ..more
What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant.
21 CFR Part 11 - Compliance for Electronic Records and Signatures
Albert Cefalo Regulatory Affairs Specialist, Analogic Corporation
This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.
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 Existing Device".
Changes and The 510(k) This webinar will examine the broad range of issues to be considered by a company when reviewing 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).
Validation and Use of Excel Spreadsheets in FDA Regulated Environments Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Statistical Concepts of Process Validation The FDA QSR requires device manufacturers to validate processes
Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University...more John E Lincoln Consultant, Medical device and Regulatory Affairs John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures. ..more Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. ..more
Dan OLeary President, Ombu Enterprises
when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational
Verification vs. Validation in Regulated Industries This webinar will teach how Design Verification and Validation, Process Validation, Risk Management and Purchasing Controls work together to produce safe medical devices.
FDA's New Draft Guidance on Medical Device Changes and the 510(k) This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510 (k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing
Excellence, focused on analytic skills and a systems approach to operations management. ..more Nancy Duarte-Lonnroth Director, Quality and Regulatory Affairs, Celestica Nancy, is the Director of Quality & Regulatory Affairs, Healthcare responsible for global coordination of Celestica's Healthcare Quality, Regulatory and FDA compliance. ..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).
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