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~ Qbd: Quality by Design in Pharmaceutical Product Development

Qbd: Quality by Design in Pharmaceutical Product Development

Requirements

  • Chemists, engineers, analysts and formulators in pharmaceutical development
  • Pharmaceutical background
  • Curiousity about learning

Description

Become Certified Professional in Quality by Design (QbD)

The certification covers all the statistical tools for QbD framework. The certification features with industry specialists and experts facilitating quality implementation in various industries. QBD implementation can give manufacturers much more confidence in the robustness of their product, potentially increases the efficiency and quality of their development and manufacturing process as well as reduces profit leakages.

QbD elements include the following: (QbD elements include the following:

(1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product;

(2) product design and understanding including identification of critical material attributes (CMAs);

(3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs;

(4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and

(5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT).

This certification will provide insight into the key principles of QbD covering quality risk management and formal experimental design. The certification is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The certification will offer an excellent introduction for those less familiar with QbD and provide those with more experience with QbD, new ideas on how to further implement the QbD programme.

The case study based approach in certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GMP professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration.

While quality by design principles have been used to advance product and process quality in industry, and particularly the automotive industry, they have also been adopted by the U.S. Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs.

QbD Overview – a US FDA initiative and its advantages

Since the introduction of Quality-by-Design (QbD) concepts, it has been accepted that quality of pharmaceutical products should be designed and built during the manufacturing process. Most of quality problems are related to the way in which a pharmaceutical product was designed. A poor-designed pharmaceutical product will show poor safety and efficacy, no matter how many tests or analyses have been done to verified its quality. Thus, QbD begins with the recognition that quality will not be improved by merely increasing testing of pharmaceutical products. In other words, quality must be built into the product.

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Who this course is for:

  • Chemists, engineers, and in pharmaceutical development
  • Anyone involved with the development of new or existing drug products; changes or improvements to existing or generic drugs are subject to QbD principals.
  • analysts
  • formulators
  • Pharma Research Scientists
  • Pharmacy students
  • Pharma professionals
  • Pharma industry professionals
  • Pharmacy


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