Day 2 - Programme

Monday, 10 September 2018

08:30 Registration and Refreshments

Registration and Refreshments


08:55 Opening Remarks from the Chairman

Chairman

Syed Abid Hassan

Syed Abid Hassan

Head of Regulatory Compliance
Jamjoom Pharmaceuticals, KSA

09:00 Implementing Quality by design in API, Formulations and Analytical Methods in the Manufacturing Process

Speaker

Dr. Gautam Samanta

Dr. Gautam Samanta

Vice President
Cipla, India

 

  • 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

10:00 Robust Corrective Action and Preventive Action (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

10:45 Coffee and Networking Break

Coffee and Networking Break


11:15 What and Why Regulatory Affairs for Pharma Industries?

Speaker

Syed Abid Hassan

Syed Abid Hassan

Head of Regulatory Compliance
Jamjoom Pharma, KSA

 

  • Why to Regulate the Drugs/Medicines?
  • What is Regulatory Authority/body?
  • What is Regulatory network?
  • Regulatory functions for a National Regulatory Authorities (NRAs)
  • Challenges of/for Regulatory Affairs

12:00 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

12:45 Prayer and Lunch Break

Prayer and Lunch Break


13:45 Enabling Lean Manufacturing Techniques to Minimise Wastage and Reduce Cost of Drug Production

Speaker

Dr. Salman Al-Mishari

Dr. Salman Al-Mishari

Regional Director
international Lean Six Sigma Institute (iLSSi), KSA

 

  • Understanding the concepts of lean manufacturing specific to the pharmaceutical manufacturing industry
  • Contemplating and analyzing the key performance indicators in lean manufacturing to ensure flawless application
  • Identifying and eliminating the non-value added processes to minimise unnecessary costs and ensure on time in full delivery
  • Highlighting practical examples of lean manufacturing through to ensure its successful implementation in the manufacturing process

14:15 Case Study: Ensuring Right Coordination, Alignment of Goals, and Understanding Between Teams for Successful Process and Technology Transfers

Speaker

Ahmed Bashtar

Ahmed Bashtar

Quality Assurance Manager
Pfizer Global Supply, KSA

 

  • 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 Closing Remarks from the Chair and End of Day 2

Closing Remarks from the Chair and End of Day 2