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Bangalore, KA, India
... Workshop Planning Project Planning & Execution Reports / Documentation Manufacturing & Production Manpower Management Material Management FDA/GMP Requirements Efficiency Enhancement PROFESSIONAL SUMMARY: Total 11 + Years SPM Designing & NPD exp. ...
- 2013 May 24
Bangalore, KA, India
... Good Comprehension of FDA, ICH-Good Clinical Practices guidelines and other regulatory requirements. Thorough knowledge and expertise in the variety of functions related to Clinical Data Management includes CDISC guidelines (Clinical Data ...
- 2013 Apr 15
Bangalore, KA, 560019, India
... based Electronic signature for all control loops for Experion MX 1 Project Scope: Electronic signature for control loops Project to comply with Honeywell Experion MX product with 21CFR FDA rule for pharmaceutical industry and certify for the same. ...
- 2013 Feb 13
Bangalore, KA, India
... Standards familiar with: o Risk Analysis: ISO 14971 o ISO 13485:2003, ISO 9001: 2008 o Medical device regulation of FDA, European (CE), Indian medical device regulations PROjects . Out-Patient-Department Process Simulation of a Tertiary Care Super ...
- 2012 Dec 28
Bangalore, KA, 562123, India
... AUDIT FACED • MHRA • WHO • EDQM • FDA AUDIT FACED (CUSTOMER) • J&J • GSK • Merck • Novartis • Cipla VALIDATION • Sterility test validation of product. • Bacterial endotoxin Test validation of product. • Dry heat sterilizer validation. • Water ...
- 2012 Nov 26
Bangalore, KA, 560067, India
... I handled US FDA audit in cipla . . I handled internal audits as an auditor for ISO 9001&22000. . Optimum utilization of man power and equipments. . Creating pleasant working condition by maintaining good house keeping and discipline. . Monitoring ...
- 2012 Nov 14
Bangalore, KA, 560102, India
... • FDA guidelines for the development of the” Gene Expression Profiling Test System for • Breast Cancer Prognosis”, at R&D centre, Avesthagen Ltd • FDA guidelines for the development of In-vitro diagnostic kit, at R&D centre, Avesthagen Ltd. HANDS ON ...
- 2012 Oct 30
Bangalore, KA, 560094, India
... and validation, study sample analysis using different assay formats such as, ELISA, ECL (MSD), CLIA, SPR, RIPA/RIA assays and Cell based assays for PK and Immunogenicity assessment under GLP /GCLP compliant practices for EMEA and US FDA submissions. ...
- 2012 Oct 02
Bengaluru, India
... The Course will cover the following Topics:- • ICH GCP guidelines • ICMR guidelines • FDA Guidelines • Schedule-Y • Central and local regulatory bodies • IEC/IRB • Intellectual Property Rights • Informed consent process • Case report form • Protocol ...
- 2011 May 30
Bengaluru, India
... (FDA, EU, ANVISA) Carried out review of clinical documents for accuracy & completion (IRB/IEC Approval, Investigator’s undertaking). Monitored General and Study specific screening procedures for Recruitment, Enrollment of volunteers and the process ...
- 2011 Feb 04