SIDDHART gANDHI

*B Cornelia Ct. Boston, MA - ****0|601-***-**** | ok246q@r.postjobfree.com

EDUCATION

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Northeastern University, Boston, MA April 2011

Master of Science in Regulatory Affairs (GPA: 3.60)

COURSE WORK KNOWLEDGE GAINED

Medical Device Development QMS, recall process, design control, IDE, device classification

Practical Aspects of Regulatory Compliance Implementation of 21 CFR 820, eCTD submissions, warning letters

European Medical Device Regulation EU directives, Notified bodies, EUDAMED, Competent authorities

Human Experimentation Pre-clinical activities, IRB, Declaration of Helsinki

Rajiv Gandhi University of Health Science, Bangalore, India Oct 2008

Bachelor of Pharmacy (GPA: 3.60)

PROFESSIONAL EXPERIENCE

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Intern at West-Coast Pharmaceutical Works LTD., Ahmedabad, India Jan 2008 –Dec 2008

• Performed Statistical sampling for product acceptance and defects

• Designed Batch Manufacturing Record according to GMP regulations

• Prepared Drug Master File for submission

• Conducted Quality Audits for manufacturing of drug products and applied preventive actions

• Prepared SOPs for quality assurance operations

• Reviewed product labels, container labels, and package inserts

ACADEMIC PROJECTS AND PRESENTATIONS

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Failure Mode and Effects Analysis March 2010

• Designed FMEA document stating reasons and effects of failure with recommended actions

• Assessed an In-Vitro medical device and filled out the FMEA document to initiate risk management

MedWatch Reporting April 2010

• Reported an adverse event by addressing details in the FDA form 3500A for an In-Vitro medical device

Commented on FDA Draft Guidance (2010-N-0247) Dec 2010

• Expressed my opinion on key points to clarify the regulatory perspective

• Prepared the presentation and lead the discussion on industry interpretation of the guidance

Response to a FDA Warning Letter Sep 2010

• Evaluated FDA’s findings and replied accordingly with applicable CAPAs

cGMP Audit – Internal audit Nov 2010

• Developed an audit check lists based on cGMP regulation; provided regulatory reference to each findings

• Audited & submitted the audit report with conclusions and corrective action recommendations

Investigational New Drug Application (IND) Feb 2010

• Developed an IND prototype in compliance with 21 CFR 312 and other applicable guidelines such as ICH modules

• Achieved CMC compilation Filled and attached the form no. 1571 to the dossier

Informed Consent (Phase 3) Nov 2010

• Produced an informed consent in compliance with 21 CFR 50 subpart B

Batch Manufacturing Record with Standard Operating Procedure Oct 2010

• Created the BMR & deviation forms to be used in simulated production of a drug product

• Produced SOPs for BMR to achieve quality policy by considering elements of SOP – a quality manual

PROFESSIONAL SKILLS

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• MDR; post marketing surveillance; package inserts & labeling review

• Regulatory Submissions: 510 (k), PMA, & CE (Technical Files)

• Regulations: QSR, MDD, IVDD, ISO 13485

• Guidelines: GDP, cGMP, GCP, GLP, ICH (Modules), & eCTD

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