Workshop Overview
QbD is a systematic method of process development which delivers consistency, robustness and increased process knowledge. QbD Approach at the Research and Development Stage itself involves due diligence particularly (but not limited to) with respect to Risk Assessment and Mitigation ensures time and cost saving processes ensuring consistent and high Quality of both APIs and FPPs. The Pharmaceutical Development Process at the Research and Development Level has to ensure identification & implementation of Key elements of QbD by adopting suitable tools. QbD Approach to API & Formulation Development has to be ensured at both Chemical Research/ Product Development and Analytical Research Development and needs to be translated into a viable product at the production scale via successful Technology transfer and Scale- up operations.It is a risk-based strategy to control the desired quality attributes of a drug
This success of adopting the QbD approach is the gateway for achieving and arriving at a time- saving and cost-saving process ensuring a high-quality and stable product consistently.
Who will benefit
- Process scientists & engineers
- Quality Assurance & Quality Control department
- Analytical chemists & Analytical Method Development Laboratories
- Regulatory Professionals
- Contract Research Organization and Contract Manufacturing Organization laboratory and their QA personnel ·
- Auditors (internal and external
- Formulators and manufacturing personnel
What will you learn
- A comprehensive Understanding of the process
- Development and use Quality Target Product profiles
- Eliminates Batch failure by risk assessment and implementation of control strategies
- Minimize deviations and costly investigation
- Increase efficiency of manufacturing process
- Streamline post approval manufacturing changes & regulatory processes
- Empowerment of technical staff
- Opportunities for continual improvement
- An appreciation of QbD in analytical chemistry, formulation, process development and manufacturing
