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Case

FDA Inspection

GN Hearing A/S

Challenge

  • At 3 months’ notice, Corporate Quality at GN Hearing was advised that an inspection would be conducted by the FDA.
  • GN Hearing’s Executive Management would accept a maximum and 3-5 deviations (483’s), no warning letter (WL).

Vi valgte Genau & More til opgaven, da vi inden den forestående inspektion havde behov for management consulting og ikke blot projektledelse.

Vi havde behov for en tæt partner, der kunne bistå os i at tænke inspektionsparathed ind i vores kvalitetsstrategi og sikre en langsigtet implementering heraf, så vi i virkeligheden altid ville være inspektionsparate.

Pär Thuresson
SVP for R&D, GN Hearing

Solution - Proces

  • Establishment for X-Point plan and identification of high-risk sites and issues.
  • Establishment of heatmap (risk matrix / risk grid) guiding priorities.
  • Breakdown of actions into workstreams and action plans.
  • Training in Good Inspection Practice, ensuring proper attitude and behaviour.
  • Good housekeeping and clean-up communication to the company one week before audit.
  • Establishment of governance structure with C-level, line management and project organization, incl. direct access to board of directors.

Results

  • One 483.
  • Converting compliance issues to a common understanding for ‘Sense of Urgency’. This has provided a good indicator of the level and the majority of GN Hearing’s work with quality and compliance.
  • Useful input for any adjustments to the strategy, competencies and organisation to execute the adjusted strategy and as well as the management and governance of the strategy.
  • It has affected the entire organization’s attitude towards Inspection Readiness and the whole proactive approach to it.
     
#MedicalDevice #FDA #Inspection #Audit #Quality #Compliance

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