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Chennai, TN, India
... FDA and BAM procedures Education Course : Master of Science in Applied Microbiology (M.Sc) Institute : Mohammed Sathak Arts and Science College, Chennai. University : Madras University (2007) Course : Bachelor of Science in Microbiology (B.Sc) ...
- 2014 May 11
Chennai, TN, 600020, India
... • Accountable for keeping records of all filings, queries from FDA and all correspondence to FDA. eCTD Training: Actavis is implementing electronic submissions software for product filings. I am responsible for recruitment of regulatory staff & ...
- 2012 Aug 25
Chennai, India
... And faced FDA, ANVISA, DGCI, MHRA, TGA, BFAC, NABL and MCC audits and several sponsor audit References 1. Sujatha Chandrasekaran,M.D, Senior Consultant, Cl.Microbiology & Serology, Global Hospitals & Health City, 439,Cheran Nagar, Perumbakkam, ...
- 2012 Feb 08
Chennai, TN, 600051, India
... TECHNICAL KNOWLEDGE: Prepared protocols for US-FDA, ANVISA, TGA, EU and Health Canada submission studies. Fair knowledge in Clinical, Bio-Analytical and Data analysis flow of activities according to regulatory requirements in BA/BE studies. Possess ...
- 2011 May 29
Chennai, India
... Having good knowledge on all guidelines ICH-GCP/GLP, FDA, ANVISA, MHRA, TURKEY, UAE, ASSEN country BA/BE guidelines. Professional Credits. Significant contribution for preparation design and development of SOPs for clinical research BA/BE studies. ...
- 2010 Dec 25
Chennai, TN, 600069, India
... strategy and implementation of new technologies, primarily Oracle Clinical 4.5.1 and SAS 9.1.3 • Install OC 4.5.1 and SAS as per FDA CFR (IQ,OQ & PQ) guidelines • Maintain PSUB and Report servers and executing batch job and schedule job services. ...
- 2010 Apr 09