Consultant, NSF Health Sciences Pharma Biotech

Email: pharmamail@nsf.org
Phone: +44(0)1751 432999
Country: Italy

Giovanni Cosmi has about 25 years of diversified experience in pharmaceutical quality operations management with several domestic and international companies (Bristol-Myers Squibb and Pfizer). He has worked at operational and strategic levels within these international organizations for the review, maintenance and improvement of quality systems to ensure compliance on FDA and EMA current Good Manufacturing Practice (cGMP) expectations.

Mr. Cosmi is eligible to act as a Qualified Person by AIFA (Italian Agency for Drugs) and holds these recognitions:

  • Rx-360 Consortium registered auditor
  • ISO 22716:2007 GMP Cosmetic auditor/lead auditor
  • EXCiPACT auditor/lead auditor (provisional registration)
  • IRCA auditor/lead auditor

His areas of expertise include:

  • PAI, FDA and AIFA inspection readiness and remediation plan support
  • GMP/GDP audits of API, raw material and excipient manufacturers, contract manufacturing organizations (CMOs), supply chains and cosmetic CMOs
  • Risk management issues
  • Lean management approach in QC labs
  • Guidance in reviewing/writing cGMP documentation
  • In-house training on cGMPs, investigation management, risk management, problem solving, human error prevention and quality systems
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