Quality Control Assurance

Dharmil Patel

***********@*****.*** **-** ***th Street, Fresh Meadows, NY 11365 347-***-****

SKILLS

• Drug Marketing Applications: IND, NDA, ANDA, Orphan Medicinal Product Designation, CMC Guidelines, CGMP Regulations for Drug: 21CFR210 and 211, Regulations and Policies associated with Drug Post Marketing Activities.

• Medical Device Regulations: Marketing Applications: 510(k), PMA, De Novo Submissions, Humanitarian Device Exemption, Quality System Regulations for Medical Devices: 21CFR820, Post Marketing Activities: Post Market Surveillance Studies.

• International Regulatory Affairs: Europe, Japan, ICH Guidelines

• QbD- Quality by Design approach in maintaining effective life cycle of the product

• Quality control procedures to test product according to its standards & specifications like HPLC, Gas and Column chromatography

• Pharmaceutical process, cleaning and analytical methods validation

• MS Office

WORK EXPERIENCE

Pharbest Pharmaceuticals Inc., Farmingdale, NY May 2014- Present Regulatory Affairs and Quality Assurance Specialist

• Determine and prepare eCTD submission to the US FDA for new products, proposed product changes and labeling changes.

• To author and file Module 3 (CMC Section) as well as Module 2 (Summary Section)

• Develop and maintain plan for proposed ANDA submissions.

• Develop and edit product labelling as per the 21 CFR requirements.

• To assist in development of formulation and process for tableting, encapsulation and coating in accordance of the current Regulatory status for particular Active Ingredient in proposed products and to maintain CMC information for individual products.

• Assist and resolve queries of FDA officers during inspection audits and submit response for FDA 483 observations.

• Communicate with regulatory agencies as needed to respond to inquiries and seek clarifications

• Maintain working knowledge of current global regulatory standards, requirements, and regulations.

• Provide regulatory support and advice to staff to ensure proper procedures are followed.

• Maintain and organize all RA documentation, databases, and library.

• Responsible for all Change Control evaluations and to develop regulatory post approval filing strategies for all approved products.

• Create Process validation protocols and performing validation studies on recent products

• Write and maintain QA documentation using Track wise system which includes SOPs, customer compliant report, discrepancy investigation, change control, CAPA, training records, Annual product review Animal Care Center -St. John’s University, Queens, NY Aug 2012-Mar 2013 Intern

• Worked in a team to feed and care for more than 100 laboratory animals

• Coordinated schedules for cleaning, sterilization, & sanitization of cages, equipment & facilities

• Received 9-10 new animals weekly and set up proper environment for animals

• Volunteered during “Hurricane Sandy” in 2012 and our team effort allowed many laboratory animals to avoid death from malnutrition and dehydration and saved many research projects being done on animals Dharmil Patel

***********@*****.*** 72-16 164th Street, Fresh Meadows, NY 11365 347-***-**** Pramukh Laboratory, Surendranagar, Gujarat, India Dec 2011-Jan 2012 Intern

• Assisted in regulatory document controls, assisted in internal audit procedure to measure the compliance of the facility with cGMP

• Worked as a part of Quality control unit for product testing, to make specification & standards for various procedures, to write SOP and to validate analytical system EDUCATION

M.S, Pharmacy Administration – Regulatory Affairs and Quality Assurance Sept 2012–May 2014 St. John’s University, Queens, NY

● Regulatory submissions- learnt various aspects of FDA regulation and Prepared IND and NDA for “Vyvanse” by using FDA guidance

• Foundation of regulatory affairs & Advanced food and drug law- learnt basis of various rules and regulations, product recall and worked on QbD guidance and 510(k) & PMA approval

• International Global Regulatory Affairs- learnt about various global regulatory bodies and worked on comparing the drug product law and regulations of USA, Japan & EU

• Product Labeling- learnt the various aspects of labeling rules and regulations. Worked on project for making PLR format label for “Unasyn” using the labeling guidance

• Good Manufacturing Practices- worked on Responding to a warning letter from FDA for a pharmaceutical company and learnt the good manufacturing Practices for Pharmaceuticals Gujarat Technological University, Gujarat, India June 2012 Bachelor of Pharmacy

PUBLICATION

Co-Author of the Book Chapter “Drug Shortages in USA” Pharmaceutical Public Policy by Thomas R. Fulda, Albert I. Wertheimer, and Alan Lyles [2014] Publisher: Jones & Bartlett Learning

[Anna Gu, MD, PhD1; Dhamil Patel, BS1; Rajesh Nayak, M.S. Pharm, PhD1 1Department of Pharmacy Administration and Allied Health Sciences, St. John’s University, Queens, NY]

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