Medical Device Training

Manasa Reddy karnati ** Eliot Crescent, Chestnut hill Avenue, Boston, MA -02467

Phone number: +1-251-***-**** email ID: *********.*****@*****.***

EDUCATION:

Northeastern University

M.S. Regulatory Affairs in Drugs, Biologics and Medical Devices (Pursuing) Overall GPA – 3.2/4

Expected Graduation Date – July 2013

Boston, MA

Jawaharlal Nehru Technological University-Greater Hyderabad Institute of Pharmacy Overall GPA – 3.7/4

Bachelor of Pharmacy - May 2011

Hyderabad, India

Relevant Course work:

a) Introduction to Drugs and Medical Devices Regulations – Applicable FDA regulations, An Overview of ISO 13485, QSR( 21 CFR 820), cGMP, FDA and ICH guidelines.

b) Human Experimentation – CFR, HHS, IRBs, Clinical Study Protocol, Clinical Trial Documents etc.

c) New Drug Development: Regulatory Overview – SOPs, Clinical Protocol, IND, NDA, ANDA regulatory submissions, FDA formal meeting request letters, cGMP, GLP and adverse event reporting.

d) Medical Device Development: Regulatory Overview – eCTD, 510(k), IDE, PMA, HDE submission, Combination Product submissions and QSR.

e) Biologics Development: Regulatory Overview – BLA application submission, BIMO, Biosimilars, Preclinical and Clinical testing Assessment.

f) Food, Drug and Medical device Law – Overview on FDA implementation of its statuary authority to protect public health.

g) International Clinical Trials- Detail Overview on Trials related to Asia, Africa and Europe

h) Practical aspects of Regulatory compliance – Informed Consent, CGMP, GLP,GCP requirements

i) FDA creation Behavior and Regulatory Culture – Political science and social approach to the different regulatory cultures.

Experience:

• Rexer Phrama limited, Hyderabad, Andhra Pradesh, India

Trainee May’11 – October’11

Technical training in using different analytical instruments and evaluation of liquid samples.

• BL Pharma Ltd January’ 11 – February’ 11

Industrial Training

Training in tablet and capsule production department and Evaluated the samples of production using HPLC, UV Spectrophotometer, also involved in writing batch record data for the samples.

Skills:

• Understanding of the Medical Device Regulatory Pathways (510k, PMA etc.)

• Good Understanding of US FDA Submissions: eCTD, IND, NDA, ANDA, BLA, QSR, ISO 13485 and Meeting request letters.

• Experienced in building a COMPLETE REGULATORY AND MARKETING PLAN for bringing a combination product in to the market which consists of drug, biologic and monoclonal antibody.

• Well versed with U.S., Europe, Asia, Japan and Health Canada Medical Device classification, registrations and regulations including their approval time lines and the procedure to conduct trial.

• Excellent knowledge in the area of regulatory requirements for investigational products, clinical trial approvals and product commercialization.

• Strong presentation skills.

• Computer skills - Working knowledge in windows platform, Proficient with the Microsoft office.

• Good oral and written communication skill.

Publications

• Done a project for analyzing the bulk and marketed form of drug-Orlistat deserted under title “Estimation of Orlistat by UV-spectrophotometry method.” and published in International Journal Of Pharmaceutical Science and Research(IJPSR).Vol. 2, Issue 09; September, 2011 (38th articles).

Reference:

Available upon request!

Contact this candidate