"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
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.
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
Audit - Program Management
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