Charisma

#	Content
1	Module 1: Introduction to Quality by Design (QbD)
2	Module 2: Regulatory Framework
3	Module 3: Quality Target Product Profile (QTPP)
4	Module 4: Critical Quality Attributes (CQAs), Critical Material
5	Module 5: Quality Risk Management (QRM)
6	Module 6: Design of Experiments (DoE)
7	Module 7: Design Space and Control Strategy
8	Module 8: Process Analytical Technology (PAT)
9	Module 9: Process Validation and Lifecycle Management
10	Module 10: Documentation and Regulatory Submission
11	Module 11: Practical Implementation of QbD
12	Module 12: Practical Workshops and Case Studies

#	Outcomes
	• Explain the Quality by Design philosophy and its advantages over traditional quality approaches.
	• Apply ICH Q8, Q9, Q10, and Q11 principles during pharmaceutical development.
	• Develop a Quality Target Product Profile (QTPP) for a new product.
	• Identify and evaluate CQAs, CMAs, and CPPs.
	• Conduct risk assessments using recognized quality risk management tools.
	• Design and analyze experiments to optimize product quality and process performance.
	• Establish a Design Space supported by scientific evidence.
	• Develop an effective control strategy throughout the product lifecycle.
	• Apply Process Analytical Technology (PAT) to enhance process understanding.
	• Support regulatory submissions using QbD principles and documentation.

#	Participants
1	� • Research and Development (R&D) Scientists
2	� • Formulation Development Scientists
3	� • Process Development Scientists
4	� • Manufacturing Engineers
5	� • Production Supervisors and Managers
6	� • Quality Assurance (QA) personnel
7	� • Quality Control (QC) personnel
8	� • Validation and Qualification Specialists
9	� • Process Validation Engineers
10	� • Regulatory Affairs professionals
11	� • Quality Risk Management professionals
12	� • Continuous Improvement Specialists
13	� • Pharmaceutical, Biotechnology, Medical Device, and Healthcare professionals
14	� • Anyone involved in product development, technology transfer, process optimization, or quality management