Lockdown: Curse or Blessing
  • CODE : WIRA-0011
  • Duration : 60 Minutes
  • Level : Intermediate
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Willi Ramseier is currently the owner and director of QVRAM GmbH of Basel, Switzerland. As an expert in quality assurance, system validation, risk awareness and management, Ramseier is a reputed trainer, mentor, and Quality Compliance officer. Previously at Hoffman-La Roche, he now consults across Europe, including as a Process-Validation Expert at Synthes-DePuy-Johnston & Johnston Switzerland and as Quality Consultant and CSV advisor and  GxP Workshop Trainer for a CROs in Cologne and Dresden. He also is a teacher and lead auditor for ISO9001:2015.

Who is needing a QMS or who doesn’t want to document how this company is managing the quality? Can I find out if my QMS is up to date with outside help (outsourcing)? Does the top management really need to start this process? Or why policy #1 is that important. Did all your PA (preventive actions) worked out well for this lockdown?

How about your contingency plans? Did they have working from home, on such a scale, in it? What about the part of your plan on how to get the needed know-how back into the company after lockdown? Are you considering employee requirements? Who provided input for those plans?

How big is the influence of the service management to the actual business processes? What steps and processes need to be lined-up for fulfilling the requirements and changes with-in the reports after the check-up? With the COVID-19 virus lockdown, lots of companies had to reduce staff, work from home or even made some redundant.

Areas Covered

  • Overview and Definitions
  • What must be in a QMS – through the eyes of an auditor
  • Best practices on how to check through a QMS for updating
  • Who has to start the process and Why
  • Fixing the (CA)PA system and its contingency plans
  • The importance of empowering the actual business part of the company
  • How to report the outcome of the check through and follow-up
  • Questions

Course Level - Management at all levels needs the information stored in a QMS for their MIS (management information system), the CAPA system, and contingency plans. Any head of department or business process owner has to check their information in the QMS to verify and keep them up to date, at regular intervals.

Who Should Attend   

  • Management at all levels
  • Heads and Leads of departments and teams
  • Quality Assurance Professionals
  • Process owner
  • Clinical trial and medical device Professionals

Why Should You Attend

This lockdown can be a curse when complaining about or trying hard to get back to how it was before. It is definitely a blessing when used to your advantage; as a manager, head of a department or team leader. Two important things come up when talking with people:

  • Many people love their work, but not the work environment
  • Now in lockdown, most people have more time (e.g.: without travelling or on empty roads)

A QMS is your basis or library for all business process related and necessary documentation. Suggest you use this “free” time to check through your QMS (quality management system) or create one if there is none.

  • $179.00

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