The manufacturing industries are experiencing the challenges from deviations and become routine, costing organization time, cost and throughout due to unacceptable levels of process understanding. The problems lie in process, analytical and formulation departments, which cumulatively delay the delivery / filing of the molecule.
Substantial business benefits are experiencing from various organizations by implementing Quality by Design guidelines framed by ICH (Q8-Q11), which reduces the COPQ (Cost of Poor Quality) and significantly improve the efficiency of the manufacturing. The presentation touches upon the holistic application of ICH Q8-Q11 guidelines in process development, analytical method development and formulation to bring proper controls to deliver the right quality materials the first time. The concept will be illustrated by the examples from literature and organizations.
By going through the webinar presentation, the audience will learn how the application of these four guidelines in the process, analytical and formulation departments holistically improve the robustness and efficiency of the process. The audience also learn systematic adoption of the principles to understand the process scientifically and risk based approach.
The key learnings from this webinar are:
- 1. Understand and systematic adoption of QbD guidelines
- 2. Understand importance of Science based Quality Risk Management in development
- 3. Systematic development of Control Strategy
- 4. Importance of Quality measurement tools
- 5. Understand the overall cumulative benefits of QbD
- 6. Adopt the advantage of continual improvement arising from statistical techniques
We invite professionals from various departments who could benefit from the implementation of the QbD guidelines and those with an interest in the subject to register for this webinar.
Dr. Srinivasa Rao Korupoju,
Director
Dr. Srinivasa Rao Korupoju is a Director, QbD with Piramal Pharma Solutions. He obtained a Ph.D from Central University of Hyderabad, Hyderabad, India. He is a prestigious JSPS, Japan and NSC, Taiwan postdoctoral fellow. He has been with Piramal for last one year and implementing QbD concepts in API and Generic drug substance development. Prior to joining Piramal, he was with Zyfine (Zydus-Cadila), Jubilant Chemsys, and AstraZeneca India Pvt Ltd. He has experience in process development, Physical Organic Concepts, Crystallography, Reaction Kinetics, hands on experience of handling PAT tools like React IR-4000, NIR, Raman and UV-Vis. He handled MODDE, Minitab, SMSwin, Berkeley-Madonna, Dynochem software. He was also the member of AstraZeneca Computational Chemistry & Process simulation group. He has 12 years of industrial process experience.
Dr. Kamal Kumar Upadhyay,
Group Leader
Dr. Kamal Kumar Upadhyay is a Group Leader - Parenteral Formulation with Piramal Pharma Solution. He Obtained a Ph.D from Pharmacy Faculty, The Maharaja Sayajirao University of Baroda, Vadodara, India in collaboration with LCPO, ENSCBP, University of Bordeaux, Bordeaux, France. He has been with Piramal group since 3 years and his team extensively working on development of complex parenteral product using QbD approach. He has more than 9 years of experience on complex parenteral product development such as liposome, lyophilized product, Non-aqueous ready to use injection etc. Prior to Piramal, he was associated with Dr. Reddy's lab, and Sun Pharma.
- ICH Q8 – Q11 guidelines
- Systematic application of Quality Risk Management
- Implications of Quality measurement tools
- Proposing control strategies
- R&D Heads
- R&D Scientists
- Analytical Head
- Analytical Scientists
- Formulation Heads
- Formulation Scientists
- Technology Transfer Heads
- Engineering Heads
- Manufacturing Heads
- Quality Control Heads
- Quality Control Scientists
- Quality Assurance Heads
- Supply Chain Heads
