DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Quality by Design using Design of Experiments (QbD)" conference to their offering.
This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.
Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program.
This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical quality attributes (CQAs). The original guidance document on pharmaceutical development provides general guidance on how these are identified: gaining knowledge about which variation in factors explains variation in product quality characteristics of drug product. It also provides a means to achieving this knowledge: through the use of formal experimental designs. The use of DOE methodology provides a means to identify those factors that impact product quality characteristics of drug product (or significant process parameters) and determine the functional relationship that links the process parameters to the CQAs.
Analyses in this course use the point-and-click interface of JMP software.
Who Should Attend:
- Process Scientist/Engineer
- Design Engineer
- Product Development Engineer
- Regulatory/Compliance Professional
- Design Controls Engineer
- Six Sigma Green Belt
- Six Sigma Black Belt
- Continuous Improvement Manager
Agenda:
Day 1 Schedule
Lecture 1: Introduction to Quality by Design (QbD)
- Quality by Design (QbD) principles
- Product Quality System framework
Primer on Statistical Analysis
- Basic statistics
Lecture 2: Primer on Statistical Analysis (cont.)
- Hypothesis testing
Lecture 3: Primer on Statistical Analysis (cont.)
- ANOVA
Lecture 4: Primer on Statistical Analysis (cont.)
- Regression
Day 2 Schedule
Lecture 1: Foundational Requirements for QbD Studies
- Setting specifications
- Measurement Systems Analysis (MSA) for assays
Introduction to Design of Experiments (DOE)
- Steps to DOE
- Defining critical-to-quality attributes (CQAs)
- Identifying and prioritizing potential process parameters
Screening Designs - Identifying Critical Process Parameters
- Factorial designs
Lecture 2: Screening Designs - Identifying Critical Process Parameters (cont.)
- Fractional factorial designs
- D optimal
Lecture 3: Response Surface Designs - Develop Functional Relationships and Establish Design Space
- Addition of center points
- Central Composite Designs (CCD)
- I optimal designs
Lecture 4: Utilizing Systematic Understanding from QbD Studies
- Presenting results
- Developing a control plan as part of a risk management strategy
- Process control and capability
For more information about this conference visit http://www.researchandmarkets.com/research/wpkdzb/quality_by_design
