Hrishikesh N Khatav

Staff Regulatory Affairs Specialist

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Location:

574 Auten Rd, Hillsborough, NJ 08844

Industry:

Medical Devices

Work:

Bio-Pharm Inc. - Greater Philadelphia Area Jul 2012 - Sep 2012
Quality Inspector (Compliance/Regulatory Affairs Associate)
Lord Venky Pharma Pvt. Ltd, Mumbai, India - Mumbai Area, India May 2010 - Aug 2010
Intern-Quality and Regulatory Affairs
GOPALDAS VISRAM & CO. LTD (GOVIL’s) - Mumbai Area, India May 2009 - Jun 2009
Implant Trainee-Quality

Education:

Northeastern University 2010 - 2012
M.S.Graduate, Regulatory Affairs for Drugs, Biologics & Medical Devices. Bombay College of Pharmacy, University of Mumbai 2006 - 2010
Bachelor of Pharmacy, Pharamcy

Skills:

Gmp
Medical Devices
Iso 13485
Pma
Sop
Regulatory Affairs
Quality Assurance
Ind
Quality System
21 Cfr
Design Control
Validation
Ce Marking
Quality Auditing
Pharmacovigilance
Premarket Approval
Good Clinical Practice
Medical Device Directive
Change Control
Anda
Nda
Ich Guidelines
Regulatory Strategy Development
Biologics
510K
Technical File/Design Dossier
Bla
Labeling/Ad Promotional Compliance

Interests:

Johnny Cash
Elton John
Pink Floyd (Band)
Health
Green Day (Band)
Children
Elvis Presley
Education
Science and Technology
Bob Marley
The Simpsons (Tv Series)
Civil Rights and Social Action
How I Met Your Mother (Tv Series)
The Big Bang Theory (Tv Series)
The Beatles (Band)
Tom Clancy's Splinter Cell (Series)
Jazz Music
Northeastern University
Social Services
John Mayer
Bob Dylan
Frank Sinatra
Metallica (Band)
Breaking Bad (Tv Series)

Languages:

English
Hindi
Marathi
Gujarati

Awards:

Gold Medalist
Indian Pharmaceutical Association-Maharashtra State Board (IPA-MSB)
For Standing 1st in First year B.Pharm Admission/ CET Topper 180/200
Winner of National level poster presentation "Regulatory Affairs: Medication Health Fraud”
63rd Indian Pharmaceutical Congress, Bangalore, India
Author(s): Prutha Desai1, Gayatri Dabadghao2, S.S Poddar2, Hrishikesh Khatav3 1 Bombay College of Pharmacy, Kalina, Mumbai-400098, India. 2 Prin. K.M.Kundnani College of Pharmacy, Colaba, Mumbai-400005, India. 3 College of Professional Studies, Northeastern University, Boston MA 02115. Health fraud is the deceptive sale or advertising of products that claim to be effective against medical conditions or otherwise beneficial to health, but which have not been proven safe and effective for those purposes. Health scams can lead patients to delay proper treatment and cause serious and even fatal injuries. Health scams have kept the Food and Drug Administration (FDA) and other agencies busier in protecting the public health. The objective of the study was to raise issues concerning the deceptive sale of medicines, role of FDA and other agencies in regulating such products, and means to create awareness among people. The study was conducted using literature obtained via the internet, books and personal interaction. Surveys were conducted and the results were analyzed using statistical procedures. It was observed that 80% of the Medical Fraternity warns their patients against such frauds, 90% are aware of the regulatory agencies and 62.5% have filed a complaint against fraudulent products.65% of the General Public was aware of the term ‘Medication Health Fraud’,60% have been victims to such health frauds and 48% consulted their physicians before buying such products. Thus it was concluded that the Regulatory Agencies should keep a constant check on products of conventional as well as alternative medicine systems to protect the public health. One must always check with health care professionals before using new medical products. People should be encouraged to report cases of deceptive sale of medicines and health care products to the FDA or other regulatory agencies.

Certifications:

Distance Learning Certificate- General Course on Intellectual Property
Regulatory Affairs Certification (Rac) (Us)
Fpx - Flawless Project Execution Project Leadership