Course Overview: Pharmaceutical Quality Control & Assurance

The Pharmaceutical Quality Control & Assurance short-term course is structured to provide learners with a foundational understanding of how quality is maintained, monitored, and improved in the pharmaceutical industry. This course introduces essential concepts related to the testing of raw materials, in-process materials, and finished products to ensure they meet established standards of safety, efficacy, and compliance.

Participants will explore both theoretical principles and practical approaches involved in Quality Control (QC)—the process of identifying and correcting defects in pharmaceutical products—and Quality Assurance (QA), which focuses on the prevention of such defects through a system of structured procedures and guidelines.

The course also highlights international regulatory frameworks such as those from the WHO, ICH, US FDA, and EMA, offering a broad perspective on how compliance is maintained in global manufacturing settings. Emphasis is placed on the importance of documentation, standard operating procedures (SOPs), validation processes, and audits in upholding consistent product quality.

Learners will gain insight into how a well-established QA/QC system contributes to operational efficiency, minimizes risks, and protects public health. However, this course does not promise specific career outcomes or certifications; rather, it is aimed at fostering a deeper understanding of quality systems in the pharmaceutical domain.

By the end of the course, learners will be better equipped to appreciate the role of quality in pharmaceutical product life cycles and understand the structured methodologies used to support product integrity.

What will students learn in your course?

Understand the fundamentals of pharmaceutical quality control and assurance systems

• Explore methods used for testing raw materials and finished pharmaceutical products
• Learn the role of SOPs, documentation, and good laboratory practices in QA/QC
• Get familiar with global regulatory guidelines like ICH, WHO, FDA, and EMA
• Understand validation, calibration, and equipment qualification procedures
• Examine the importance of audits, deviation handling, and corrective actions
• Explore quality risk management and its application in manufacturing settings
• Learn the difference between QA (preventive) and QC (detective) approaches

Requirements / Prerequisites for Taking the Course

Learners should have a basic understanding of pharmaceutical sciences or life sciences to comprehend quality frameworks and lab-based practices effectively.

• A background in biology, chemistry, pharmacy, or related fields will be helpful for understanding industry-standard protocols and analytical techniques.
• Access to a device with a stable internet connection is necessary to participate in live or recorded sessions and access learning materials and resources.

Who is this course for?

Undergraduate or postgraduate students in pharmacy, life sciences, or biotechnology

• Entry-level professionals in pharmaceutical manufacturing or quality departments
• Researchers or lab technicians seeking to understand industry QA/QC standards
• Academic learners or career switchers exploring compliance roles in pharma
• Anyone interested in the safety and regulatory aspects of drug production