Skills and Experience
  • QSR 21 CFR Part 820, 803, ISO 9000, ISO 13485, 93/42/EEC and ISO 18001 compliance audits. 
  • Pre-assessments, including QSIT for regulatory cGMP compliance, FDA Establishment inspections, Notified Body certificate renewal and ANVISA inspection. 
  • Quality Manual governance and SOP management and implementation, CAPA and complaint management, Occupational Health and Safety implementation. 
  • CA Communication: (MHRA, Swissmedic, ANSM (formally AFSSAPS), HPRA, TGA, BfArM, FDA, Medsafe: meetings in person, telephone conferences and e-mail communication for vigilance reporting, FSCA, complaint trends and CAPAs. 
  • Regulatory Strategy/Product Registration: Identify requirements to bring new products to market and new markets for existing products. Compilation and submission of registration dossier. 
  • Compilation, review and approval of technical files; DHF review to 21 CFR Part 820 requirements, devising solutions if required.  
  • Training: preparation for inspection (FDA); DHF structure and requirements; communication to Competent Authorities including preparation of Field Safety Notices.  
  • Project Management: site transfer plans; change management; company acquisitions and mergers.  
  • Transfer of production lines within an existing manufacturing facility and transfer of existing production to a new facility.   
  • Site assessment for manufacturing suitability following company acquisition. 
  • Third party assessment and approval including clean room packaging for devices prior to sterilization and analysis of medicinal products to meet GMP EU and US requirements. 
  • Advise and contribute to IQ/OQ/PQ protocols/reports for equipment commissioning at production transfer.

Specialisms (Capabilities) 
  • Auditing  
  • Inspection Management 
  • Quality System Implementation 
  • Competent Authority Communication 
  • Regulatory Strategy/Product Registration 
  • Technical/Design History File Management 
  • Training 
  • Project Management 
  • Production Transfer 
  • Site Accreditation 
  • Third party assessment and approval

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