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Chemical Analysis and Quality Assurance
She has expertise on Varian instruments ICP-AES; ICP-OES; AAS; GC-MS; NMR; Pelkin elmer ICP-OES; FT-IR; Schimatdzu HPLC; Elementar CHNSO; LC-MS; JEOL EPR; Bruker NMR operation and interpretation of results of various metal containing complexes and compounds of organic nature such…
Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible…
Pharmaceutical Engineering Maintenance, Calibration, Training, Safety System Implementation & Audits
As he has been the Head of Facility & Chief Engineer & Administration of world class standards,he was overall in charge of Facility Management of Medicorp’s as well as Unit I & VI. Of Aurobindo’s world class manufacturing facilities complying…
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Software Application Development, IT Compliance, Pharmaceuticals, Large systems Release Engineering
Expert has designed a number of customer relationship management solutions (CRM) using different platforms such as salesforce.com, salespharma.net. Also, in his capacity as a director of technology for a number of companies he has been involved in the technical evaluation,…
Biotechnological Pharmaceutical Chemical Process Development Design Engineering
Expert has applied his extensive background in chemical engineering in various areas including pharmaceutical process and product development; developing new products for pharmaceutical and consumer industries; process, equipment, and analytical method validation in biotechnology areas; and designing and improving various…