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Held in conjunction with QbD in Pharma Development 2014
26 Feb 2014, at 9.30 AM to 5.30 PM in Mumbai, India
As the demand for quality and efficiency intensifies year on year, the need for measures such as PAT and QbD becomes more prominent. The constantly evolving landscape of the PAT and QbD industry sees an increased regulatory pressure to adopt these quality practices in line with producing high quality drug products at all times.
In view of this we are offering a unique opportunity to learn from leading PAT and QbD expert from the industry! Who Should Attend?
• Technical Directors
• Heads of Quality Compliance & Regulatory
• Process Development Scientists
• Senior PAT and QbD specialists and experts
• Project Managers
• Senior Scientific Advisors
• Senior Scientists Learning Objectives
1. To familiarize the background of QbD in the light of QTPP objectives
2. To select vital few factors for prioritization of CQAs, CPPs and CMAs on the basis of screening, QRM or FMEA
3. To learn the significance of design and control spaces and the methods to earmark them
4. To go through various case studies on Risk Management in Product & API
5. Scientific understanding of PAT, its implementation strategy & various PAT tools
6. Relationship of New Process validation Guidelines by FDA with QbD / PAT for Life Cycle Management of the product
7. New process validation – differences between FDA / EMA / WHO guidelines Workshop Contents Quality by Design (QbD)
(A): Successfully Implementing Quality by Design elements:
Real user experience of QbD submissions; gain expertise on PAT techniques and Process Validations; learn how to develop an effective design space and the overcome the challenge of scale up.
(B) Question-based Review: Implementation of Quality by Design during & after submissions
• Benefits of a new regulatory quality assessment system: Question-based Review. Introducing concepts, principles and procedures
• Highlighting the main objectives of QbD including product specifications, process capability, manufacturing efficiency, and post-approval change management
• Further clarify elements of QbD such QTPP, CQA, product and process understanding, and control strategy
(C) Implementing QbD within the Generic Industry
• Preparing for the upcoming FDA regulation regarding QbD
• Overcoming the challenges of moving from conventional processes to a complete QbD driven process
• Best practices learned for future implementation of QbD processes
Process Analytical Technology (PAT)
• What is PAT
• Implementation strategy
• Understanding PAT process: In line, At line, On line, Off line.
• Various PAT tools like NIR , Raman Technology, Hand-Held equipment & their benefits
• Extent of cost savings …case studies
FDA’s New Process Validation Guidelines
• Purpose of ….New Guideline Effective Jan 2013
• Principles of all 3 stages
• Documentation at each stage
• Batch release stages
• QbD / PAT / Life Cycle Management –Process Verifications Relationship.
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 Ranjit Barshikar, QbD/cGMP Consultant, Pharma Quality Management Consultants
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