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Introduction to Pharmaceutical Quality Course & Certification
Intermediate
4.7
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3 hours
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About
Introduction to Pharmaceutical Quality provides a foundational understanding of the principles, systems, and regulatory requirements that ensure the consistent manufacture of safe, effective, and high-quality pharmaceutical products. It introduces the role of quality in protecting patient safety, maintaining compliance, and supporting operational excellence across pharmaceutical organizations.
This Introduction to Pharmaceutical Quality Course & Certification covers essential topics including Good Manufacturing Practice (GMP), quality management systems, quality assurance and quality control, documentation practices, data integrity, deviations, CAPA, change control, risk management, and regulatory expectations. Upon successful completion, learners receive a certification demonstrating their understanding of pharmaceutical quality principles and compliance requirements.
Who Should Enrol?
- Pharmaceutical and Biotechnology Professionals
- Quality Assurance and Quality Control Personnel
- Manufacturing and Production Staff
- Regulatory Affairs and Compliance Professionals
- Clinical Research and Laboratory Personnel
- Life Science, Pharmacy, and Chemistry Graduates
- New Employees Entering the Pharmaceutical Industry
- Anyone seeking a foundation in pharmaceutical quality and GMP compliance
What you will learn
Understand the fundamentals of pharmaceutical quality, including quality culture, patient safety, regulatory compliance, and the importance of quality throughout the product lifecycle.
Learn the key principles of Good Manufacturing Practice (GMP), quality systems, documentation requirements, and the roles of Quality Assurance (QA) and Quality Control (QC).
Develop knowledge of quality management systems, deviations, change control, CAPA, data integrity, and continuous improvement within pharmaceutical operations.
Gain an understanding of regulatory expectations, inspection readiness, risk-based quality approaches, and best practices for maintaining product quality and compliance.
Course Syllabus
- The concept of quality in pharma
- Quality Control (QC)
- In-Process Quality Control (IPQC)
- Quality Assurance (QA) and its independence
- How QA, IPQC and QC work together
- What a QMS is
- The four parts: Management, Resources, Operations, Evaluation
- ICH Q10 Pharmaceutical Quality System
- The QMS document hierarchy
- The TQM philosophy and the PDCA cycle
- The 6Cs of TQM implementation
- Methods: Six Sigma (DMAIC), Lean, Kaizen, QFD, 5S
- The 7 QC tools, 8 wastes and common barriers
- Purpose and scope of the Quality Manual
- Structure, format and control
- The Quality Policy and its content
- Policy, Manual and SOP — why, what and how
- Quality by Design versus Quality by Testing
- Quality Target Product Profile and Critical Quality Attributes (CQAs)
- CPPs, CMAs and the design space
- Control strategy, DoE and PAT
- What the ICH is and its four categories
- The Q-series from Q1 to Q14
- Q8, Q9 and Q10 — the quality triangle
- Newer guidelines: Q11, Q12, Q13, Q14
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay grounded in the standards that define modern pharmaceutical quality — the ICH Q-series (Q1 stability through Q14 analytical procedure development, including Q8, Q9 and Q10), ISO 9001 and ISO 13485, and the cGMP quality-system expectations of 21 CFR 820.20 and EU GMP.
Learn from Industry Experts
The course was assembled by Regulatory Affairs experts who have implemented and defended pharmaceutical quality systems in pharma and medical-device organisations, so examples are drawn from real projects and concepts are framed around regulator expectations.
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