Consultant, NSF Health Sciences Pharma Biotech

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

Massimo Barbanera has over 30 years experience in pharmaceutical quality and compliance. He has conducted research activities at the University of Catania in Italy in cooperation with the University of Gainesville in Florida.

For 28 years, Mr. Barbanera worked at Wyeth Lederle – Catania Pharmaceutical & Animal Health Plants (American Cyanamid until 1998 and Pfizer Group since 2009). He was a leader of the quality and compliance cultural change at the site for a number of years, establishing a quality system in accordance with regulatory and corporate requirements.

From 2007 to 2013, he was Site Quality and Compliance Director and Qualified Person, responsible for quality assurance, quality control, auditing and compliance. Prior to that, he was head of a corporate compliance project and Associate Senior Manager for Quality and Compliance.

Between 1986 and 1999, Mr. Barbanera held various roles at the Catania Site in QC and QA, culminating in the roles of Head of Production of the Non Parenterals and Parenteral Syringes Departments and Head of Pharma Warehouses. Between 1998 and 1999, he was also responsible for the Safety, Industrial Hygiene and Environmental Department.

His areas of expertise include:

  • Product release to the market
  • Quality systems - Management and approval of internal SOPs and GMP documents, retention samples management, change control, deviations, customer complaints, product recalls, annual product reviews and more
  • Quality control - Chemical, instrumental and microbiological analyses; management of technology transfer and validation of new methodology and/or new products; stability studies management and more
  • Auditing and compliance – Management of internal and external audits, including GMP suppliers and materials qualification, regulatory and compendial continuous compliance verification, and management of inspections and regulatory dossiers
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