Quality Assurance Medical Device

NALINI GOVADA

Apt # **C, Smith street, Boston, MA

******.*@*****.***.*** 917-***-****

EDUCATION

Master of Science (M.S) in Regulatory Affairs for Drugs, Biologics and

Medical Devices

Northeastern University, Boston, MA, USA

Current GPA - 3.8 /4

June, 2013

Bachelor of Pharmacy

September 2006 - June 2010

Bapatla College of Pharmacy, Bapatla, India

ACADEMIA EXPERIENCE

. Developed an extensive knowledge of USFDA and the governing

regulations for Drugs, Biologics and Medical devices.

. Have prepared sample informed consent and study protocol documents.

. Well versed with the FDA requirements for an IND, NDA, BLA, 510(k),

PMA, IDE submission

. Good understanding of 21 CFR 820, 21 CFR 50, 21 CFR 56, 21 CFR 201 and

21 CFR 11.

. Knowledge on IRB submissions, informed consent, clinical study

reports, investigator brochure, protocol development and serious

adverse events reporting (SAE).

. Well versed with ICH guidelines, ISO 13485, Quality system

management, cGMP, Quality Assurance, MDR, CAPA, Regulatory strategy

development and compliance.

. Knowledge on Regulatory requirements for Advertisement and Promotion

of medical products.

. Good understanding about Australian and Canadian medical device

regulations and a thorough knowledge on Health Canada.

ACADEMIC PROJECTS

. Prepared a sample IND for controlled release OMEZ capsules for Gastro

Esophageal Reflex Disorder.

. Developed a sample NDA for controlled release OMEZ capsules for Gastro

Esophageal Reflex Disorder.

. Regulatory development plans for various medical devices were

predicted and strategies were developed.

. Prepared Canadian Medical Device Application for New Class III medical

devices.

. Prepared a Case study on Robotic surgery machine- da Vinci surgical

system.

WORK EXPERIENCE

Pellets Pharma Limited, Hyderabad, INDIA

June 2010- June 2011

www.pelletspharma.com

Jr. Executive in Quality Assurance

Pellets Pharma is committed to provide better medicines for better quality

life. Pellets Pharma is manufacturing modified release pellets and retard

micro granules of various APIs with various blends in ready to fill forms.

. Responsible for carrying out in process checking and sampling of

intermediate, bulk and finished products.

. Reviewed BMR (Batch Manufacturing Records) and BPR (Batch Packaging

Records) and released the finished products for distribution.

. Assisted department head in preparing SOPs, documents as per cGMP

requirements

. Assisted supervisors in carrying out internal quality audits

. Controlled documentation issuance and retrieval including BMR, SOPs,

and other controlled documents

. Actively participated in process validation, execution of validation

protocols and sampling as per the plan

. Did Terminal Inspection of finished goods at warehouse before final

dispatches to various regulatory and domestic market

. Monitored control samples and their documentation

Dr. Reddy's Laboratories Ltd, Hyderabad, INDIA

April 2009- June 2009

www.drreddys.com

Intern in FTO unit II

Dr. Reddy's is a global pharmaceutical company providing affordable and

innovative medicine through pharmaceuticals, APIs, Global generics and

Proprietary products.

. Attended training on cGMP procedures.

. Performed formulation production for tablets and prepared binding

solutions.

. Performed in process quality control tests for solid dosage forms such

as weight variation, hardness and friability tests.

. Understood manufacturing processes, engineering techniques, quality

control procedures.

. Got hands on experience in operating UV spectrophotometer, HPLC,

disintegration and dissolution apparatus.

. Carried out finished product packaging and labeling.

. Performed various calibration procedures.

TRAINING:

"Development of clinical study report"

February, 2013

Online training sponsored by DIA

. Understood the key regulatory requirements for integrated and

abbreviated clinical study reports.

. Reviewed the format and structure of a clinical study report.

. Established the relationship of the clinical study report to the

clinical study protocol

. Developed various approaches to solving problems related to

preparation, protocols, patient disposition,

. compliance, and changes to statistical methods

Developed a comprehensive and easily reviewable clinical study report

ACHIEVEMENTS & SKILLS

. Presented two papers in National level paper presentation competitions

on the topic "Recent Advancement r-DNA technology and Edible vaccines.

. Published paper in Research Journal of Pharmaceutical Dosage forms and

Technology.

. Microsoft Office, C language and Base SAS.

Contact this candidate