Quality Assurance Medical Device

Prajakta Palshikar

** ******** ******, ***# **, Boston, MA, 02115 857-***-**** | *****************@*****.***

Education:

Northeastern University, Boston, MA, USA April 2012

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

Mumbai University, Mumbai, India May 2009

Bachelor of Science in Pharmacy

Professional Experience:

Intern, Elder Pharmaceuticals Pvt. Ltd., Mumbai, India May-June 2008

• Rotational training in departments like Manufacturing, Storage, QA/QC, Packaging and Labeling

• Identified deficiencies in the label during the approval process of label by reviewing the labeling material

• Assisted in maintaining QA documentation systems like issuance, retrieval and archival of Quality documents in compliance with cGMP

• Assisted in handling process deviation and validation, documented instructions for material evaluation, incoming inspection of raw materials.

• Monitored the supply of inventories.

• Identified and segregated the qualified and non-compliant materials and provided feedback on inspection results.

• Performed Quality Control and Quality Assurance tests including pH, use of HPLC on various formulations, analyzed the results and prepared reports for the same

Intern, Dortmund Pvt. Ltd, Mumbai, India May-June 2007

• Rotational training in departments like Storage, Manufacturing, QA/QC

• Documented the Certificate of Analysis for various Bulk Product Excipients and assisted in the preparation of Change Control Form

• Worked with and operated a variety of pharmaceutical equipment including tablet press machines, fluid bed dryer, automatic capsule filling machine and HPLC

Academic Projects:

• Drafted a request for Pre-IND meeting for a fictional drug in accordance with 21 CFR indicated for Stroke

• Drafted a complete Regulatory Development Plan for a fictional drug indicated for Stroke

• Participated in Manufacturing of a Pumpkin Drug Cake under simulated conditions and prepared a Batch Manufacturing Record (BMR)

• Drafted IND, NDA and BLA documents for fictional pharmaceutical drug and Biologic in accordance with 21 CFR 312 and 601

• Drafted a 510 k notification document for a fictional medical device which is an Orthopedic/Spine product indicated for

Osteoporosis in accordance with 21 CFR 807

• Submitted a research project on Reprocessing of Medical Devices and on the medicinal product Gilenya, a drug indicated for Multiple Sclerosis

• Prepared an Informed Consent document for conducting Phase I Clinical Trials of combination product for the treatment of Advanced Stage Lung Cancer in accordance with 21 CFR 50

Major Skills:

• Regulations governing clinical trials and IRB

• Clinical Trials documents such as Protocols, Informed Consents, IDBs, Clinical Trials Agreements and Material

Transfer Agreements, Data Repositories and Usage Agreements, SOP’s, CRF’s and OOS investigations, financial disclosure forms,

Form 1572

• ICH, FDA guidelines and CFR(CMC regulations and guidances)

• Regulatory submissions of FDA like IND and NDA , BLA, eCTD and DMF

• Filing a 510(k) Pre-market notification, Pre-Market Application processes and Investigational Device Exemption applications

• GxPs(GMP, GCP, GLP) and cGMPs

• Regulations of Europe, Canada, China, India , Australia and Japan

• Good oral and written communication in English

• Ability to handle multiple tasks and efficient in team work

• Thorough knowledge of MS Office-(MS Excel, MS Word, Microsoft Power Point)

Affiliations

• Member of Regulatory Affairs Professional Society.

• Member of Indian Pharmaceutical Association.

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