Instructor

Joachim Paap

Medical Device Q&R Compliance, Chemgineering Business Design GmbH

Joachim Paap has more than 18 years of experience in the medical device industry in Quality, Regulatory & Compliance (product classes I to III). For many years he worked for internationally operating and leading medical device manufacturers as Q&R Manager (Quality Management Representative), Director Q&R Compliance, Q&R Trainer and Senior Auditor.

During his career Joachim Paap has been active throughout Europe, North, Central and South America, Africa, Middle East, India, Asia and Australia.

Competences

  • Global QMS Compliance for Medical Device Companies (e.g., ISO 13485: 2016, ISO 9001: 2015, US FDA QS Reg, EU MDR, Canadian CMDR, Anvisa RDC 16, jPMD, MDSAP, ISO 62304)
  • QMS design and implementation
  • Internal Quality Assurance Agreements
  • Certification Landscape
  • Audit – Program Management
  • Internal audits
  • QMS – gap analysis
  • QMS remediation, including process and SOP re-design
  • Inspection / NB audit preparation
  • front office / back office management for inspections (e.g., US FDA) and audits (NBs)
  • Q & R Education programs
  • Q & R Training Design & Delivery (Classrooms & Webinars / E-Learning)
  • Auditor Training and Qualification
  • GDP – Good Documentation Practices
  • Q & R Supplier Management, including Quality Assurance Agreements
  • Global Supplier Qualification & Audits, incl. Distributors
  • Six Sigma Management
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