Tp Narayan Email & Phone Number

• TPAN Consulting Inc. is an independent consultancy specializing in providing the following services for the pharmaceutical, medical device and biotechnology industry:
• Implementation of QMS as required by ISO 13485 and 21CFR part 820; device development plan quality monitoring for class III medical devices
• Quality Systems and Process Validation – Batch records, SOP’s, and process validation
• CAPA/NC – Review, assessment, analysis, remediation and/or development of CAPA’s/NC’s for manufacturing operations
• Audits of Contract Manufacturing (CMO) facilities
• Audit of Contract laboratory facilities

Basel, Baselstadt, CH

Basel, Baselstadt, CH

Basel, Baselstadt, CH

Basel, Baselstadt, CH

Abbott Park, Illinois, US

I was a key contributor towards a) preparation of IDE & PMA submission documents for Xience V Everolimus and Promus Everolimus drug eluting coronary stent system, a Class III medical device, b) Implemention of Quality systems according to ISO 13485, 21CFR parts 820, 211 and 11, c) Directing & Managing the Quality Control, Analytical method.

Hunt Valley, Maryland, US

I was responsible for a) hosting & managing Client, EMEA & FDA audits, b) preparing audit responses and ensuring corrective actions for observations of Clients, EMEA & FDA audits, c) conducting GMP audits of contract laboratories..

I was responsible for a) directing & managing the analytical laboratory activities, b) development/validation of analytical methods, c) managing stability studies, d) regulatory submission of ANDA for generic dosage forms, and d) hosting regulatory inspections.

Ph.D, Organic Synthesis

M.A., Organic Synthesis

M.Sc, Chemistry

Master Of Arts - Ma, Organic Chemistry