Summary
Multiple ICH and regulatory agency guidelines applicable to CMC activities explicitly cite the use of statistical methods to meet the ultimate goal of ongoing supply of safe and efficacious products that meet patient needs. However, benefits of these methods extend beyond only compliance. Statistical thinking and application provide substantial business and patient benefit as they provide robust evidence of product and process understanding, acceptable risk and adequate process performance. In this 3-day course, examples will be presented for the statistical methods commonly leveraged for CMC submissions to define sampling and acceptance criteria (multiple applications), inform the process definition and control strategy, manage patient risk, and assure ongoing product quality.
- The most common and powerful statistical methods used across the CMC spectrum of activities
- The relationship of statistical methods and Quality Risk Management (QRM)
- Key reasons to use Design of Experiments
(DOE) for process development - Understanding the components of a statistical
sampling plan and statistical intervals - Leveraging science, patient needs and statistics to establish specifications
- Robust methods for comparability and homogeneity
- Connecting stability trends, shelf life and release specifications
- Elements and nuances of an Ongoing Process Verification (OPV) Program
- The powerful combination of your eyes, your knowledge, and a “good” graph
Key Topics
- Integrating data analytics to accelerate development, improve processes and reduce risk
- Design of Experiments to enable Quality by Design and determine the optimal control strategy
- Sampling and acceptance criteria: Establishing Specifications; Comparability; Homogeneity; Process Validation/PPQ
- Stability monitoring and shelf life
- Data visualization
- Ensuring ongoing quality
- Common pitfalls
Who should attend?
- Process Validation
- Process Development
- Manufacturing Science and Technology
- Process Improvement
- Quality Assurance
- Data Scientist
- CMC Statistician
- Technology Transfer
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Digital and LinkedIn certificates
Trainers
CMC Statistics
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
