Regulativer og Standarder

Regulatory Compliance 

Jeg har igennem en lang karriere i life science industrien, som ansvarlig for kvalitet og regulatoriske forhold, arbejdet med mange forskellige regulativer og standarder herunder

  • Medical Device Directive & Regulation
  • FDA (US Food & Drug Administration Requirements) – herunder part 820 Quality System Regulation
  • US Pharmacopeia – fokus på primær plastemballage
  • European Pharmacopeia - fokus på primær plastemballage
  • European Food Law – fokus på plastemballage
  • REACH
  • cGMP – Current Good Manufacturing Practice
  • ISO 9001 - Quality Management
  • ISO 15378 - Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
  • ISO 13485 - Medical devices -- Quality management systems -- Requirements for regulatory purposes
  • ISO 31000 - Risk Management
  • ISO 14644 - Cleanrooms and associated controlled environments
  • ISO 14698 - Cleanrooms and associated controlled environments – Biocontamination control
  • ISO 8573 - Compressed Air
  • ISO 2859 - Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
  • GAMP 5 - Good Automated Manufacturing Practice

Da jeg ikke har listet alle de standarder, som jeg har arbejdet med, er du meget velkommen til at kontakte mig for yderligere information, hvis dine behov ikke umiddelbart er dækket af ovenstående.