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Project Experience

Examples of how MWA associates have assisted our clients:

Biotechnology

  • Assisted in qualification of pilot plant facility
  • Conducted training sessions in GLP and GMP practices for R&D personnel
  • Implemented quality systems for start-up company
  • Performed internal and external audits for cGMP compliance
  • Provided manufacturing support for clinical production
  • Served in QA and manufacturing management roles
  • Validated laboratory equipment for analytical testing
  • Investigated and resolved non-conformances and implemented CAPAs
  • Assisted with resolving outstanding customer complaints
  • Set up QA department, prepared SOPs, and managed audit program
  • Set up environmental monitoring program and developed supporting SOPs

Medical Device | In-Vitro Diagnostics

  • Developed and implemented a preventative maintenance program
  • Developed and documented a Risk Management Plan, and conducted the Hazard Analysis, FMECA, and FTA
  • Provided regulatory support for 510k filing
  • Developed a strategy for handling combination product FDA requirements late in the development cycle, and wrote compliance documentation
  • Established quality systems for device manufacturing
  • Implemented corrective actions (CAPA) based upon FDA warning letter citations
  • Prepared and implemented QSR training program for combination products
  • Developed and executed validation protocols and prepared the reports
  • Performed internal audits per QSRs, identified system deficiencies and assisted with corrective actions

Pharmaceutical

  • Assisted in PAI preparation by reviewing technical data and training personnel in FDA response techniques
  • Assisted with Drug Master File preparation
  • Facilitated remediation of FDA warning letter citations
  • Validated manufacturing, lab, and process equipment, software, and hardware
  • Implemented quality systems for clinical and commercial manufacturing
  • Performed GCP monitoring and conducted audits at clinical sites
  • Performed over 100 audits annually of suppliers, contractors and clients
  • Established quality systems and served as QA manager/director for virtual companies
  • Wrote investigation reports for deviations and non-conformances
  • Acted as QA Director
  • Performed customized and general GMP and compliance training