FDA 21 CFR Part 11
  • CODE : WIRA-0009
  • Duration : 60 Minutes
  • Level : Advance
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Willi Ramseier is the pragmatic system thinker, project management skills, risk management know-how, expertise in CAPA system and QMS (quality management system), a consultant for general quality issues (especially for start-ups)

His assets :

  • Presenter, speaker, (SAS Stockholm; Allan Lloyd Amsterdam; DIA data Madrid, DIA Barcelona, ERES Roche)
  • Vendor Audits and Quality Reviews
  • Concepts for the quality management system, CAPA system, Change management, ISO9001:2015
  • Process management (Policies, SOP’s, SA entries, System Validation); Risk assessment and management; CAPA plans (create, review and approval); Equipment (inventories, qualification, validation); Documentation, Templates; Training (GxP, CSV, CAPA, Company rules, Project management methodology)

Variety of work :

  • IT projects (from quality assurance and validation to access concept and security)
  • Lab projects (pathology, CPU, DNA, RNA)
  • Clinical trial teams quality assurance (Report validation, endpoint adjudication, Web sites)
  • CRO’s (clinical research organization)

This webinar will introduce the reasons why we have big issues about data handling and storage. What is important, should be acknowledged, and trained in a company which depends on data. Not rocket science, but common sense and organized working. The uncertainty about correctly handled and stored data.

Areas Covered

  • Planning of collecting data from information (or a frame)
  • Data collection, interim storage, copying, and distributing
  • Data manipulating and transforming back into information
  • Data and information storage and archiving
  • Business process vs. resource management
  • General vs. specific guidelines

Course Level - Advance

Who Should Attend

  • Clinical Operations Professionals
  • Sponsors Clinical Study Groups
  • Quality Assurance Professionals
  • Data Management Professionals
  • Electronic Systems Developers (also Big Data)
  • Service Providers (for storing and maintaining any samples or data of importance)

Why Should Attend

Everyone wants to do a good job. Data handling is a major part in your business process, and the employees are frustrated, because the integrity of data is not known, and the general guidelines are of no use - this is your lecture.

  • $179.00

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