Medical Device Project

Veneela Prathima Duggirala

*** ********** ******, ****: 23 Email:*********@*****.***

Chelmsford MA 01824 Ph: 508-***-****

-------------------------------------------------------------------------------------------------------------------------------------------------------------OBJECTIVE: To work in an environment that will enhance my intellectual skills.

EDUCATION:

M.S in Regulatory Affairs for Drugs, Biologics, and Medical Devices

Northeastern University, Boston – July 2010 – July 2011.

BACHELOR’S OF PHARMACY

Jawaharlal Nehru Technological University- India

RELATED COURSES:

Introduction to Regulatory Affairs, New Drug Development, Medical Device Development, Biologic Development, Human Experimentation, Food, Drug & Medical Device Law, Practical Aspects of Regulatory Compliance, Bio Medical Intellectual Properties, Emerging Trends in Medical Devices, Global Awareness- EU regulations.

PROFESSIONAL SKILLS:

Knowledge on guidance's and regulations of ICH and FDA.

Familiar with compliance requirements with in cGMP, safety and regulatory environments.

Good understanding on the regulatory strategy for drug discovery and product development.

Possess knowledge on regulatory submissions: IND through NDA.

Knowledge on clinical trial process

PROFESSIONAL EXPERIENCE:

Worked from March2005-April 2006 on studying about various medicines and their dosages, assisting the staff in pre-operative and post operative procedures in the SURGICAL Department. in NIHARIKA HOSPITAL

Worked as an Assistant from April 2006-May 2007 under the guidance of different specialists in medical profession such as Anesthesia, Surgery by studying about various antibiotics and analgesics in HIRA HOSPITAL.

Worked as a Lab Assistant from May 2006-June 2007 in pharmacology lab by mixing and preparing various chemicals which are required for the lab work at Shadan women’s college of pharmacy

Worked as a Teaching Assistant from June 2007-March2008 under the guidance of professor Mrs.Nishat Fatima in the subject of pharmacognosy by teaching the students about various medicinal drugs and chemistry of natural drugs at Shadan women’s college of pharmacy

Worked as a volunteer from September1 5th 2008 to March 27th 2009 at All Health Primary care- Florida by taking the history of patients, checking their vitals like temperature, respiratory rate, pulse rate and blood pressure of the patients

Submission of two regulatory intelligence papers on FDA clearance of a test that helps patients with

Kidney transplants and on FDA News and Events to hold Daylong Meetings on medical device Innovation

in March 2011 in the field of Emerging trends in Medical devices

Submission of three IRAC papers in March 2011 in the field of Bio medical intellectual properties

Submission of Intellectual Property Case Study in March 2011 on Intellectual property rights in the field of

Bio medical intellectual properties

PROJECTS:

Project at Veco labs private limited which includes the completion of industrial training in the area of QUALITY CONTROL AND PHARMACEUTICAL FORMULATION DEPARTMENT. July 2007- August 2007

Project at Watsol organics limited which includes the completion of industrial training in the area of R & D PRODUCTION DEPARTMENT. June 2007- August 2008.

Project on Risk Management in September 2010 in the field of Medical Devices

HONORS AND AWARDS:

Seminar and paper presentation in February 2008 in the field of pharmacology which includes study of

Cancer and its therapeutic Drugs at Shadan women’s college of pharmacy.

Presented seminar in September 2007 in the field of pharmaceutical technology which includes

containers and closures used for the Parenteral Drugs at Shadan women’s college of pharmacy.

Project to write about any GMP’S in June 2011 in the subject Introduction to Regulatory affairs

Case study in June 2010 in the field of Human experimentation

Group project working as FDA and regulatory affairs professionals in September 2010 in the field of

Biologics

Seminar and paper presentation on New safety controls for Long- acting Beta Agonists and

Medications used to treat Asthma in march 2011 the field of New Drug Development

RESIDENCY STATUS:

Permanent resident ( Green card Holder)

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