Main Conference Programme

Day 2 – Monday, 10 September 2018

08:30 Registration and Refreshments

Registration and Refreshments


08:55 Opening remarks from the Conference Chair

Opening remarks from the Conference Chair


Building Quality By Design (QBD)

Building Quality By Design (QBD)


09:00 Understanding the role of Quality by design in formulations in the manufacturing process and identifying its impact on cost, quality and yield


  • Evaluating QbD concepts with respect to the innovative tools used for flawless manufacturing performance and better scale up
  • Identifying the critical quality attributes in manufacturing through QbD to improve product manufacturing
  • Understanding statistical analysis, designing, software parameters and practical implementation of QbD in manufacturing to ascertain increased productivity and consistent quality
  • Determining the strategies for application of QbD concepts to existing products to ascertain competitive advantage
  • Understanding QbD through practical examples in terms of analysis of output parameter, results expected and variation
  • Assessing the QbD application with respect to specific QbD regulatory requirement to ensure compliance and effective manufacturing

09:45 CAPA Guidelines

CAPA Guidelines


10:30 Coffee and Networking Break

Coffee and Networking Break


Capacity Planning, Facility Design and Scale-Up

Capacity Planning, Facility Design and Scale-Up


11:00 Undertaking optimum capacity planning and expansion to ensure high quality and timely delivery of products

Speaker

Dhananjay Kulkarni

Dhananjay Kulkarni

Director – Plant Operations
Aja Pharma, KSA

 

 

  • Devising facility design techniques to ensure robust processes and better technology transfer
  • Laying out strategies for facility design for manufacturing multiple products so as to achieve consistent quality and swift operations
  • Formulating innovative capacity management techniques to ensure reduction in operational cost

11:45 Devising effective inventory management strategies to ensure optimum utilisation and minimal wastage


  • Understanding current trends in evolution of inventory management techniques for cost reduction, enhanced quality and on time delivery
  • Integrating production scheduling & production planning so as to achieve optimum capacity utilisation and adequate lead inventory management
  • Evaluating better material handling techniques with respect to transportation of dry and wet powders and hazardous liquids
  • Identifying innovative demand management techniques to avoid stock outs and ensure better inventory management

12:30 Prayer and Lunch Break

Prayer and Lunch Break


13:30 Understanding and overcoming change management complexities involving a matrix of complex processes and balancing it with regulatory compliance, investment justification and productivity improvement


  • Focusing on change management in existing plant involving various strategies in plant refurbishment resulting in increased productivity and yield
  • Understanding effective measures in plant refurbishment and change management to ensure quality yield complying with stringent regulatory requirements
  • Evaluating best practice strategies to manage ageing manufacturing plants according to changing business dimensions from local to global manufacturing hub
  • Undertaking various measures of training people to manage change in manufacturing plant and thereby remove inconsistencies in change management
  • Exploring practical examples and case studies on various ways of change management in old manufacturing plants to get a better understanding of the plant refurbishment strategies

14:15 Case Study: Ensuring right coordination, alignment of goals, and understanding between teams for successful Process and Technology Transfers


  • Defining intermediate output material Critical Quality Attributes (CQAs) and CQAs per manufacturing step
  • Assessment and comparison of intermediate output material CQAs and CQAs per manufacturing step
  • Identification of Critical Process Parameters (CPPs) and establishment of values
  • Experimental and documented execution of each trial

15:00 Determining and Overcoming the scale up challenges in APIs and formulations to ensure flawless large scale manufacturing and swift commercialization


  • Troubleshooting inconsistencies in the scale up process to meet the global quality standards
  • Determining effective methods for unit operation studies to ensure flawless scale up process
  • Understanding the appropriate application of tools, techniques and software for problem free scale up
  • Identifying innovative technologies in process, equipment and facility validation to ensure successful scale up
  • Undertaking efficient bioequivalence studies in the scale up process with respect to converting a reaction into a process
  • Identifying the challenges and inconsistencies that arise during scale-up implementation and determining solutions to overcome these challenges

15:45 Closing Remarks from the Chair

Closing Remarks from the Chair


16:00 End of Pharma Manufacturing and Quality Conference

End of Pharma Manufacturing and Quality Conference