Tanvi Khot

Tanvi Khot

Mumbai, Maharashtra, India
2K followers 500+ connections

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Sm Shetty College, Powai

About

Client acquisition skills consisting of: 
● Prospecting methods
●…

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Experience

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    Mumbai, Maharashtra, India

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    Mumbai, Maharashtra, India

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    Mumbai

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    Mumbai

Education

  • Sm Shetty College, Powai

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  • Activities and Societies: Dance

Projects

  • 5th Annual Global Pharma Regulatory Summit 2016, Mumbai

    We are delighted to inform you that CPHI is back with the 5th Annual Global Pharma Regulatory Summit 2016 (GPRS) happening in Mumbai from 25th – 27th April 2016.
    Kindly find all the details in the attached agenda for your perusal.


    Key Topics

    Day 1 – USA

    • Controlled correspondence Guidance
    • ANDA Submissions- Refuse to Receive standards
    • Case study - Identification, assessment, and control of Genotoxic impurities to demonstrate how proper management of GTIs…

    We are delighted to inform you that CPHI is back with the 5th Annual Global Pharma Regulatory Summit 2016 (GPRS) happening in Mumbai from 25th – 27th April 2016.
    Kindly find all the details in the attached agenda for your perusal.


    Key Topics

    Day 1 – USA

    • Controlled correspondence Guidance
    • ANDA Submissions- Refuse to Receive standards
    • Case study - Identification, assessment, and control of Genotoxic impurities to demonstrate how proper management of GTIs can occur with appropriate regulatory guidance

    • Devising the strategies for preparing for USFDA audits by complying with USFDA norms
    • Highlighting the ways and means of measuring and assessing elemental impurities to ensure permitted daily exposure is not exceeded

    Day 2 – Europe

    • Impact of IDMP implementation on data, processes and systems
    • Outlining the criticalities in CMC requirements for topical ophthalmic dosage forms
    • Assessing the regulations in bioequivalence studies for modified release products

    Day 3 - ROW

    • ASEAN Region - GMP inspection and obtaining loan license and registration
    • Regulatory scenario in Latam, South Africa, Srilanka, Russian and GCC Countries

  • CAPA Process Validation & Risk Management Workshop

    CAPA Process Validation & Risk Management Workshop scheduled for the 30th & 31st of March in Dubai, UAE.

    This 2 day workshop focuses on some of the current and major topics such as –

    • ICH Guidance on Quality Management Systems
    • Adopting best practices of SOP’s
    • CSV and documentation requirements
    • CAPA and Compliance requirements for CAPA
    • Certificate of training completion provided at the end of the course for presentation to worldwide regulatory agencies
    •…

    CAPA Process Validation & Risk Management Workshop scheduled for the 30th & 31st of March in Dubai, UAE.

    This 2 day workshop focuses on some of the current and major topics such as –

    • ICH Guidance on Quality Management Systems
    • Adopting best practices of SOP’s
    • CSV and documentation requirements
    • CAPA and Compliance requirements for CAPA
    • Certificate of training completion provided at the end of the course for presentation to worldwide regulatory agencies
    • Numerous real world case studies faced by companies worldwide.

    Trainer : Mr. Chinmoy Roy
    He is an internationally recognized subject matter expert in GAMP, CSV, CAPA, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. Recently he was on the panel of experts on Data Integrity along with FDA inspectors to address Data Integrity issues at ISPE’s Annual meeting which concluded in October 2014 in Las Vegas, USA. Has 40 plus years of experience in validating and obtaining “fit for use” certification for over 200 IT systems

  • Unannounced Audit

    CPHI’s upcoming with 2 days Workshop on “Unannounced Audit” is happening from 25th – 26rd August, in Mumbai & 27th -28th August in Ahmadabad.

    With the increase in the number of inspections conducted by the global regulatory authorities, it is extremely important for the Indian Pharma companies to be prepared to face unannounced audits. In the past it has been observed that almost 90% of the warning letters were issued to firms when the authorities inspected the plan unannounced…

    CPHI’s upcoming with 2 days Workshop on “Unannounced Audit” is happening from 25th – 26rd August, in Mumbai & 27th -28th August in Ahmadabad.

    With the increase in the number of inspections conducted by the global regulatory authorities, it is extremely important for the Indian Pharma companies to be prepared to face unannounced audits. In the past it has been observed that almost 90% of the warning letters were issued to firms when the authorities inspected the plan unannounced.
    Understanding the criticality involved during unannounced audits, CPhI in collaboration with USFDA experts brings you a two day workshop on techniques on handling audits.

    Kindly find attached herewith the Agenda for your perusal.

    Workshop Leaders :

    Christopher Smith- Former USFDA

    Chinmoy Roy- FDA Consultant

    Ileana Barreto-Pettit, FDA Drug Investigator

    Workshop Highlights:

     Module 1: Auditing Fundamentals
     Module 2: Audit Success factors
     Module 3: Establish a Internal audit program
     Module 4 : Audit Reporting
     Module 5: Mock Audit
     Module 6 : Vendor Audits
     Module 7: Part 11/ Data Integrity audits
     Module 8: QRM Audit
     Module 9: FDA Audit preparation & planning

  • 2nd Annual Sterile Workshop

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    CPHI’s upcoming with 2 days Workshop on “2nd Annual Sterile Pharma Workshop” is happening on 18th -19th November, 2015 in Mumbai.

    Sterile Manufacturing companies today are required to be compliant with stringent FDA regulations with regards to sterility assurance and validation. Under these circumstances, a thorough understanding of the FDA’s expectation from the sterile manufacturing plans becomes necessary. With more and more companies under the risk of being issued with a form 483…

    CPHI’s upcoming with 2 days Workshop on “2nd Annual Sterile Pharma Workshop” is happening on 18th -19th November, 2015 in Mumbai.

    Sterile Manufacturing companies today are required to be compliant with stringent FDA regulations with regards to sterility assurance and validation. Under these circumstances, a thorough understanding of the FDA’s expectation from the sterile manufacturing plans becomes necessary. With more and more companies under the risk of being issued with a form 483 and subsequently a warning letter, the importance of ensuring failure free sterility assurance and audits for sterile products & facilities is imperative.

  • Healthcare IT- Forum 2015

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    UBM India is back with one of its most anticipated annual gatherings, the Healthcare IT Forum 2015 scheduled for the 14th & 15th of December 2015 in Mumbai, India.

    This conference and exhibition aims at bringing together over 100 CIOs, CTOs, Chief IT Officers, IT thought leaders. and department heads from leading hospitals, medical and healthcare facilities across India to initiate a discussions around improving existing healthcare processes, integration of facilities and interfaces…

    UBM India is back with one of its most anticipated annual gatherings, the Healthcare IT Forum 2015 scheduled for the 14th & 15th of December 2015 in Mumbai, India.

    This conference and exhibition aims at bringing together over 100 CIOs, CTOs, Chief IT Officers, IT thought leaders. and department heads from leading hospitals, medical and healthcare facilities across India to initiate a discussions around improving existing healthcare processes, integration of facilities and interfaces, usage of big data and predictive analytics for more effective and efficient care to each patient.

    Find attached the draft program agenda along with the confirmed speaking faculty for the forum. Please do review agenda and help us understand about your organization participation at the Healthcare IT Forum 2015.

    Key Speakers:

    Rajendra Pratap Gupta – Member – Government of India
    Dr. Girdhar Gynai- Director General – Association of Healthcare Providers India
    Rajesh Batra- VP-IT – Kokilaben Dhirubai Ambani Hospital
    Dr. Chandil Kumar – Chairman- HL7 Healthcare Standard Institute
    Dr. Ruchir Dass- Health Informatics expert and Founder- HealthCursor Group
    Lalit Mistry- Associate Director- Healthcare- KPMG India
    Dr. Supten Sarbadhikari- Project Director- Centre for Health Informatics- National Health Portal
    Arvind Sivaramakrishnan- Chief Information Officer- Apollo Hospitals Enterprise Ltd.
    Ravindra Karanjekar- Executive Director & CEO – Global Hospital

    Key focus of the event:

    Healthcare IT market in India – Current situation, e-solutions in practice
    Big data practices, data governance & data integrity for effective hospital management (HER, EMR, DICom etc)
    Telemedicine in India- Awareness, Scope and Implementation Challenges
    CIO Panel Session- Leading the IT in a Health Care Organization
    Mobile Health IT- A solution to the enterprise – wide digital image access and analytics

Languages

  • English

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  • Hindi

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  • Marathi

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