Thanabalan Subramanian
Head of Digital Quality, Integrity Project Solutions Limited (A ProductLifeGroup Company)
Thana’s current role is Head of Digital 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).