Drug Regulatory Affairs in Pharmaceuticals- R.A/ QA/QC Training Program by "sowbhagya management consultants".
Placement Assistance is assured
A combo pack+: Tenure 35 days, 2Hours every day.7.00 A.M to 9.00 A.M
New Batch From: 20-12-08
Fee for all 3 courses together i.e RA/QA/QC and Industrial tour : Rs 10,000/-
Trainer is a renowned USFDA and EU/TGA/MHRA Consultant having 26 years experience in the pharmaceutical industries located in India and abroad.Currently he is a chief consultant for a Giant Pharma company located in USA.
The course contains 8 modules.
Fundamentals and QA systems will be taught first followed by RA training and Practical exposure on DMFs, ANDA and Technical dossiers.
Industrial tour will be organized for few days in the industries located at Hyd at no extra cost.
weekly assessment and counseling will be given at every week end to gear up the candidates to get through the interviews at first time itself.
Placement Assistance for all the Qualified students.
Module-I: Familiarization to the Pharma Industry & Profession
Module-II: Quality Assurance
Module-III: Quality Control
Module-IV: Regulations In the United States of America
Module-V: Regulatory Systems and Agencies in EU & ICH and WHO
Module-VI: Industrial Tour in an API company and Dosage Manufacturing Company
Module-VII: Practical Exposure on Preparation of DMF,
Module-VIII: NDA, ANDA and Technical Dossiers for Global submissions
Each participant will be given a project on DMF compilation of Dossiers,Filing of Applications. Besides this each candidate will be provided with the study material worth of Rs 7500/-with the contents of PDP delivered by the Faculty.
About the Trainer:
Raja Rao holds two Masters degrees, one in industrial Science and the other in International laws. He is owning an institute Sowbhagya management consultants . He has about 25years of experience in Q.A, Q.C, and R.A in various giant pharmaceutical companies. Currently working as an associate in GMP and Regulatory affairs for a US company SFC chemicals Ltd advisory services division located its corporate office at Barrington Chicago, IL 60010,USA. He possesses 26 years of industrial experience in pharmaceutical/ Bio pharmaceutical companies and Bulk active pharmaceutical industries .His major achievements include obtainment of USFDA,MHRA,TGA and WHO approvals.
He is maintaining good industrial relations with the Majority of the companies which helps the candidates to get the recruitment.