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• Delamination studies of glass vials and PFS• Deviations and Change Controls• Complaints Handling and Field Alerts• Project Management • Device Development tracking team member• Preparation and review of Annual Product Reviews (APR)• Expert Witness - manufacturing process patent infringement case for a Japanese company in the LA District Court and a litigation case involving a medical device.• Quality by Design (QBD)• Compliance audits • GMP training, • SOP’s, • QA/QC support, • Preparation of DMF (drug master file), ANDA (Abbreviated new drug application), CMC (Chemistry, Manufacturing, and Control), ANDA Suitability petitions,• Preparation and review of Site Master File,• PAI (pre-approval inspection) preparation, • Stability studies.• Adjunct Faculty at University of Phoenix - Teaching courses in Chemistry, Biology, Health and Nutrition, and Environmental Science

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 development/validation, Stability studies activities and Chemical Mixing laboratory, and d) Developing and establishing a solvent recovery facility for manufacturing.

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.