Pharma QbD Workshop

16th – 17 th Dec. 2021


QbD Approach at the Research and Development Stage itself involving due diligence particularly (but not limited to) with respect to Risk Assessment and Mitigation ensures time and cost saving processes ensuring consistent and high Quality of both APIs and FPPs.

Pharmaceutical Development Process at the Research and Development Level has to ensure identification & implementation of Key elements of ObD by adopting suitable tools.

QbD Approach to API & Formulation Development has to be ensured at both Chemical Research/ Product development and Analytical Research Development and needs to be translated into a viable product at the production scale via successful Technology transfer and Scale- up operations.

The QbD approach not only convinces the Regulators and Facility Inspectors of a thorough understanding of our manufacturing and analytical processes but also ensures achieving and maintaining the established/prescribed/desired product quality thereby expediting the approval of Marketing Authorization Application Dossiers in multiple global markets which ultimately meets the Business aspirations of Pharmaceutical Organizations and also ensures that Quality medicines are available to the end-users.

This success of adopting the ObD approach is the gateway for achieving and arriving at a time- saving and cost-saving process ensuring a high-quality and stable product consistently.


Rajani Jha

IIT Kanpur Scholar, Synthetic Organic Chemistry, Trainer for QbD, GMP & Regulatory

Rajani Jha

IIT Kanpur Scholar, Synthetic Organic Chemistry, Trainer for QbD, GMP & Regulatory

A specialist in International Regulatory Affairs and Quality Assurance for APIs for US and European as well as Asia-Pacific markets. Armed with 25 years plus experience in various pharma companies viz.,Ranbaxy, Morepen, Torrent, Nicholas Piramal, Unimark Remedies, Glenmark Generics Limited , Indswift Laboratories Limited and Naari Pharma. Has worked at various leadership positions across multidisciplinary cross functions as :

  • Chemical Research Division [ RnD]
  • Drug Regulatory Affairs [Different CFTs
  • Corporate Quality Assurance [Different CFTs]
  • Corporate Regulatory Affairs
    RA & QA[RnD], RnD & Corporate, CQA/ Manufacturing plan

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Benefits Of Attending:

  • A comprehensive Understanding of the process
  • Development and use Quality Target Product
  • Eliminates Batch failure by risk assessment and implementation of control strategies
  • Minimize deviations and costly investigation
  • Increase efficiency of manufacturing process
  • Streamline post approval manufacturing changes & regulatory processes
  • Empowerment of technical staff
  • Opportunities for continual improvement
  • An appreciation of QbD in analytical chemistry, formulation, process development and manufacturing

Who Should Attend:

  • Process scientists & engineers
  • Quality Assurance & Quality Control department
  • Analytical chemists & Analytical Method
  • Development Laboratories
  • Regulatory Professionals
  • Contract Research Organization
  • Contract Manufacturing Organization
  • laboratory and their QA personnel
  • Auditors (internal and external
    Formulators and
  • Mnufacturing personnel

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    Course Fees

    INR 9,000 + 1, 650 GST= 10,650

    Register & Pay Now

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