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Understanding and Implementing a Quality by Design (QbD) Program  

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Seminar Summary:

This seminar will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. (see full course description)

 

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Training Course Syllabus:


Understanding and Implementing a Quality by Design (QbD) Program

This seminar will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application.

To aid the learning process, the principles of QbD will be applied to a specific program, implementation of the new Elemental Impurity guidelines, ICH Q3D. Practical implementation of ICH Q3D requires a risk based approach, but the fundamental challenge is to find a means to categorize risk. This means an exhaustive assessment of all the components of manufacturing including API, excipients, water, manufacturing equipment, processing aids, and container closure system to determine their contributions to all elemental impurities. Alternatively, it is possible to simply do final product testing on finished dosage forms. This carries the risk, however, that failure here involves discarding the batch.

Learning Objectives:

Upon completing this course participants should:
Understand the principles behind using QbD to develop a pharmaceutical product including
Understand what is meant by Quality be Design
Understand the benefits from applying a QbD approach
Provide key steps to implement a QbD program
Understand the important tools used to implement a QbD approach
Understand how to utilize a risk-based approach to address implementation of elemental impurities requirements

Areas Covered:

ObD principles discussed include:
Quality Target Product Profile (QTPP)
Risk Assessment
Using Models
Design of Experiments
Developing a Design Space
Process Analytical Technology (PAT)
FMEA and Control Plan
Target Operational Profile
Control Strategy
Elemental Impurities (Q3D) Risk Assessment Strategies

Topic Background:

The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use.” Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that are not easy to grasp.

DAY 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
Introductions and QbD Overview
QbD Overview
What is QbD
What does a QbD program look like
Quality Target Profile Introduction (QTPP)
QTPP ICH background
Factors to consider
Implementation
Introduction to Risk Evaluations and Early Risk Assessments
Description
Information flow
Tool Use example
Benefits
Integrating the QTPP and risk assessments into your development program
Mapping QTPP and Risk Assessments into the scientific investigations
Prioritizing efforts
Identifying Critical Quality Attributes
Design Space Development
Definition
Concepts to develop a design space
Graphical representation
Later Stage Risk Evaluations. (FMEA)
Purpose of an FMEA
Design and application
Designing the Control Strategy
Definition
Approach for developing
Technology Transfer
Definition and Importance of Technology Transfer
The use of gated review processes
Tools and templates

DAY 02(8:30 AM - 4:30 PM)

Elemental Impurities: Background
EI limits and comparative requirements between ICH vs FDA
Calculations of Dosage Form Limits
EI Prioritization by toxicity
Various Strategies for Implementation
Test every finished batch for all EI
Risk Based Assessment
Common document approach
Where to focus attention
Component approach vs final product testing
FDA guidance
Decision-making based on safety, economics, product risk
Required documentation, submissions
Regulatory
Product Risk Assessment
Results of testing conductedv
Regulatory submissions-new specs, methods, validations
Quality
New GMP procedures to demonstrate compliance
Change management controls
Manufacturing Process Analysis
Water
API
Excipients
Stainless transfer tanks and lines
Container Closure System
Analytical Testing, Validation, Transfer
Placing an R&D method in a plant environment
Instrument selection criteria

Seminar Summary:

This seminar will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. (see full course description)

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