Thanabalan Subramanian

Thana’s current role is Head of Quality at Integrity. Responsible for the Quality Services organisation covering CSV compliance projects (prospective & remediation), Audit management, Data Integrity programmes, training and organisation design/change. Having previously worked for Otsuka, Roche, GE Healthcare, GSK, GlaxoWellcome & Merck Sharp & Dohme. Originally qualified as a Chemical Engineer, has a Masters Advanced Manufacturing Systems. 30 years of industry experience, the majority being focused on CSV across all the GxP’s with experience of Steriles, Primary & Secondary manufacturing, and R&D, (pre-clinical, clinical, pharmacovigilance & manufacturing). An experienced auditor and practitioner of CSV projects, ranging from spreadsheets to SAP, laboratory, clinical, PV & process control systems. Secretary for the ISPE GAMP Global Steering Committee. Former Chair of the ISPE GAMP CoP Europe Steering Committee. Also, a member of the ISPE GAMP CoP UK, eClinical SIG and CSA SIG. Member of the IT committee for the Research Quality Association (RQA). Thana’s current role is Head of Quality at Integrity. Responsible for the Quality Services organisation covering CSV compliance projects (prospective & remediation), Audit management, Data Integrity programmes, Training and Organisation design/change. Having previously worked for Otsuka, Roche, GE Healthcare, GSK, GlaxoWellcome & Merck Sharp & Dohme. Originally qualified as a Chemical Engineer, has a Masters Advanced Manufacturing Systems. With over 30 years of validation experience, the majority being focused on CSV across all the GxP’s with experience of Steriles, Primary & Secondary manufacturing, and R&D, (pre-clinical, clinical, pharmacovigilance & manufacturing). An experienced auditor and practitioner of CSV projects, ranging from spreadsheets to SAP, and lab, clinical, pharmacovigilance & process control systems. Currently is the Global Steering Committee Secretary and outgoing Chair of the ISPE GAMP CoP Europe Steering Committee. Also a member of the ISPE GAMP CoP UK, Clinical SIGs and IT committee member for the Research Quality Association (RQA).