Medical Device Quality Control

Education:

Master of Science in Regulatory Affairs of Drugs, Biologics and Medical Devices

Northeastern University, Boston, MA April 2012

Relevant Courses:

Introduction to Drug and Medical device, Biologics Development, New Drug Development, Medical Device Development, Practical Aspects of Regulatory Compliance, Human Experimentation, Managing International Clinical Trials, Food, Drug and Medical Device Law, Biotech Product Registration and Global Awareness: Canada, Asia, Latin America Regulations

Bachelor of Science in Pharmacy

University of Mumbai, Mumbai, India May 2009

Relevant Courses:

Food and Drug Laws, Pharmaceutical Technology, Clinical Pharmacy, Cosmetics, Pharmacology, Pharmaceutical Analysis and Quality Control, Pharmaceutics, Business and Management Studies

Work Experience

Manja Pharmaceuticals Pvt. Ltd., May-Jun 2007, Jan–Jun 2010 QC/QA Intern

• Abetted basic principles and functions of production, quality control and quality assurance

• Designed protocols for in-process quality control tests of oral dosage forms

• Executed statistical sampling for product acceptance and defects

• Drafted SOP and batch manufacturing records (BMR)

• Documented validation reports of equipment such as HPLC, GC, GLC, UV spectrometry

Cognizant Technical Solutions

Junior Data Analyst for Drug Safety and Pharmacovigilance May 2009-Dec2009

• Performed quality control on cases as per the SOP’s to ensure information reported to Drug Safety Surveillance is complete and accurate within timelines

• Assessed the adverse events for marketed and over the counter medications along with medical devices, investigational drugs and vaccines

• Reviewed and assessed all source documents

• Voice and accent training to take calls from patients and health care professionals

• Accurately identified and captured adverse events related to marketed and clinical trial drugs

• Captured the adverse event accurately into the adverse event reporting Form and reported it to the Drug Safety Surveillance

• Submitted monthly reports relating to Adverse Events, Product Complaints & Medical Inquiries to the client

• Updated the product profile for the available client products and ensure timely book-in and data entry of cases

Regulatory Skills:

• Premarket approval, PMA supplements, 510K/PMN, Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) for Medical devices

• cGMP, GLP, Regulations governing Clinical Trials

• Labeling Requirements, annual reports, Case Report Forms (CRFs), Serious Adverse Event reports, GCP guidelines

• Trial Master File, site communication and management activities, receiving and monitoring regulatory documents

• FDA, ICH, APEC and GHTF Guidelines

• 21 CFR 820,803,806, ISO 13485 and ISO 9001:2000

• International medical device regulations

• Corrective Actions and Preventive Actions (CAPA) and Medical device reporting

• IND, NDA, ANDA, and BLA for Drugs, and Biologics

• eCTD’s for Drugs and STED for medical devices

Academic Projects:

• Drafted an informed consent for subject enrollment in a Phase 1 clinical trial of life threatening diseases and also for SRC and IRB approval

• Proposed a Regulatory strategy for marketing a combination product containing drugs, biologics and medical devices

• Participated in manufacturing exercise of drug in compliance with cGMP simulated environment

• Presented a paper on conducting multicenter clinical trials in US, EU, China and Latin American Countries

• Drafted a fictional IND, NDA and BLA and Annual report submissions for Biologics and Drugs.

• Prepared a Regulatory development plan for marketing of a medical device in US, Japan, and EU

• Designed a fictional Phase III trial for CC- 5013- drug for Myelofibrosis

• Presented on Reprocessing of Single Use Medical Devices

Activities and Achievements:

• Certification in Patent Drafting as per Intellectual Property (IP) Rights

• RAPS Member

• Drug Information Association Member

• Student Coordinator at Northeastern University

Computer Skills:

• Efficient in Microsoft Word, Excel, Power Point

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