Why the PA comes before CA
  • CODE : WIRA-0008
  • 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: why there are big issues around changes to processes, e.g.: the changes introduced by resource management, or process information vs. software standards.

Possible alteration: disclosing and training of the business process; to discrepancies, misunderstandings, misconceptions, and ignoring, and to working organized. Only changes are risky, therefore prevent or control them.

Areas Covered

  • Change management (processes)
  • Process values vs. price tags
  • Variety and change vs. data management
  • Business process vs. resource management
  • General vs. specific guidelines

Course Level - Advance

Who Should Attend

  • Clinical process Owner
  • Sponsors Study Groups
  • Quality Assurance Professionals
  • Any process owner
  • Systems Developers
  • Service Providers

Why Should You Attend

When planning a process or a project (a controlled change to a process), the involved know what is important and why it is. It is important to know what must be in place to prevent uncontrolled changes. If you are unsure about how to deal with uncontrolled changes or preventive actions, and what to do when some change breaks through, then come and listening-in.

  • $179.00

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