Main Forum Programme

Day 2 – Monday, 10 September 2018

08:30 Registration and Refreshments

Registration and Refreshments


08:55 Opening Remarks from the Forum Chair

Opening Remarks from the Forum 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 gain competitive advantage
  • Considering QbD through practical examples in terms of analysis of output parameters, results expected and variation
  • Assessing the QbD application with respect to specific QbD regulatory requirements to ensure compliance and effective manufacturing

09:45 Robust CAPA System and its Role on Effective Implementation of Quality Management

Speaker

Salah M. ALKhowaiter

Salah M. ALKhowaiter

Director, Quality and Compliance
Saudi Pharmaceutical Industries & Medical Appliances Corporation (SPIMACO), KSA

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 Ensuring High Product Integrity and Quality by Effective Handling of Temperature Excursion and Cold Chain Shipment Challenges

Speaker

Dr. Wasif Azeem

Dr. Wasif Azeem

Director Quality Operations
Jamjoom Pharma, KSA

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 plants 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 a local to global manufacturing hub
  • Undertaking various measures of training people to manage change in a manufacturing plant and thereby removing 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 Commercialisation


  • Troubleshooting inconsistencies in the scale up process to meet the global quality standards
  • Determining effective methods for unit operation studies to ensure a flawless scale up process
  • Understanding the appropriate application of tools, techniques and software for a problem free scale up
  • Identifying innovative technologies in process, equipment and facility validation to ensure a 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 ChairClosing Remarks from the Chair and End of Main Forum

Closing Remarks from the Chair and End of Main Forum