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Foundations of Pharmaceutical Quality Assurance and GMP (Udemy.com)

QA & GMP in Pharma: Practical Tools for CAPA and Deviation Control, OOS OOL

Created by: Anna Khalko

Last updated September 2026

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What you will learn

  • Overview of Quality Assurance in Pharma
  • Regulatory environment and key standards (FDA, EMA, ICH)
  • Roles and responsibilities of QA professionals
  • Introduction to Quality Management Systems (QMS)
  • Basic documentation and record-keeping requirements
  • Importance of compliance and risk management
  • PPS Practical Problem Solving

How it compares

Against the other 503 rated Udemy courses in Teaching & Academics on CourseDuck:

  • Rating4.3 out of 5higher than 16% of them
  • Reviews134#407 of 504 by number of reviews
  • Length2.2 hoursshorter than 67% of them
  • Last updatedSeptember 2026more recently than 97% of them

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Course Description

This comprehensive course covers everything you need to know about Quality Assurance (QA) in the pharmaceutical industry. You will learn the essential principles of Good Manufacturing Practices (GMP) to ensure that medicines are produced safely and meet quality standards.

The course teaches you how to handle deviations — unexpected problems or mistakes during manufacturing — and how to conduct thorough investigations to find their root causes. You will also learn how to develop and implement Corrective and Preventive Actions (CAPA) that fix problems and prevent them from happening again.

In addition, you will gain an understanding of the role of Quality Control (QC) and how it works with QA to maintain product quality. The course includes modules on managing documentation, audits, and regulatory requirements from agencies like FDA, EMA, and ICH.

You’ll also explore advanced topics like practical tools such as templates and checklists to streamline your daily QA work.

This course is designed for beginners who want a solid foundation as well as professionals aiming to deepen their knowledge and skills to advance their careers in pharmaceutical quality management.

By the end of this course, you will be equipped with real-world knowledge and practical skills to confidently manage quality processes and contribute to safe, effective pharmaceutical manufacturing.

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Instructor Details

Anna Khalko


I am a Quality Assurance specialist with extensive experience in GxP compliance, Quality Control, and data integrity within pharmaceutical and biotech industries. Over the years, I have gained hands-on expertise in reviewing and approving critical QA documentation, conducting risk assessments, and managing deviations and CAPA processes to ensure regulatory compliance and product quality.

In this course, I will share practical knowledge and step-by-step guidance to help you master Quality Assurance principles, understand regulatory requirements, and effectively handle QA tasks in a GMP environment.

My goal is to provide you with clear, actionable insights so you can confidently apply QA best practices in your professional role.

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Reviews

4.3

134 ratings on Udemy

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By Rosangela Maria Rodrigues Carvalho Frita on 6/11/2026

This is a great introduction to fundamentals in quality assurance. Only negative is the high use ou AI, specially section 4 should be reviewed, even "blue diamond" is read, clearly identifying this as AI reading a text. In this section, the same idea is repeated over and over, instead of explained in a structured way how to apply the PPS methodology (which from the explanation leans heavily on lean 6-sigma and perhaps this should be clearly said). Please take this not as serious critic but as a suggestion for improvement! I really liked the last session, where regulatory framework is improvement and tips on how to keep up to date are given, for someone starting this can be sometimes overlooked.

By Stepan Karabinyosh on 11/20/2025

Overall, a good introductory course. However, the difference in sound is really disturbing especially if you are using headphones. It sometimes sounds like it was cut out from a different source and sometimes has a terrible background noise. I wish there were more printouts and resource materials.

By Mani Hadadi on 9/5/2025

There could be more explanations or notes on the screen meanwhile she is talking about that subject.

By Sara Musi on 8/17/2025

Mi sto trovando bene, è tutto molto chiaro e comprensibile, ma noto dei bag durante la spiegazione e delle interruzioni a fine video che non mi permettono di dare tutte le stelle.

By yaniv giman on 8/4/2025

The content was comprehensive, well-structured, and easy to follow, making complex concepts accessible even for beginners. The instructors were highly knowledgeable and engaging, providing real-world examples that helped deepen my understanding of quality assurance processes. The course also offered practical exercises and assessments that reinforced my learning. Overall, this course significantly enhanced my QA skills and confidence, and I highly recommend it to anyone looking to excel in quality assurance.

By Andrey Protsko on 7/30/2025

The Foundations of Pharmaceutical course provided a clear and concise introduction to key pharmaceutical concepts. The instructor explained everything in an easy-to-understand way, with helpful examples and quizzes. I gained a solid understanding of the drug development process. Highly recommended for beginners or anyone looking to refresh their knowledge.

By Igor shevchenko on 7/28/2025

*The "Foundations of Pharmaceutical Quality Assurance and GMP" course was clear, well-structured, and highly informative. It provided a solid understanding of key GMP principles and QA responsibilities. The real-life examples and regulatory context were especially helpful. I recommend it to anyone starting in pharmaceutical manufacturing or quality.*

By Yulia Hololobova on 7/27/2025

This course provides a clear and well-structured introduction to the foundations of pharmaceutical quality assurance and GMP. The content is presented in a simple and professional manner, making it easy to understand even for those who are just beginning their career in pharma or quality. I really appreciated the real-life examples and practical insights that help connect theory with daily work in a GMP-regulated environment. The course materials are informative, and the instructor explains complex topics with clarity and enthusiasm. Highly recommended for anyone interested in pharmaceutical quality systems, especially for beginners or those looking to refresh their knowledge. Thank you, Anna, for this course!

By Sasha Khalko on 7/23/2025

I highly recommend this QA course! It offers a clear and practical approach to learning Quality Assurance, even for beginners. The instructor explains everything step by step, and the hands-on projects really help you build real-world skills. If you're looking to start a career in QA or improve your testing knowledge, this is the perfect place to start.

By Liran Elias on 7/5/2025

Game-changer for anyone in pharma QA! This course gave me the tools, clarity, and confidence to handle CAPA and deviations like a pro. Foundations of Pharmaceutical Quality Assurance and GMP is practical, powerful, and essential for taking your QA skills to the next level.

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Overall Score : 86 / 100