Quality Assurance in Pharmaceutical Manufacturing Training

Learning Outcomes

• Apply the principles of quality assurance to pharmaceutical manufacturing processes.
• Implement Good Manufacturing Practice (GMP) requirements in accordance with SAHPRA and WHO guidelines.
• Monitor and evaluate QA systems to ensure compliance with regulatory standards.
• Analyze deviations and non-conformances to identify root causes and implement corrective actions.
• Demonstrate documentation practices essential for QA, including batch records and standard operating procedures.
• Evaluate the effectiveness of QA systems through internal audits and inspections.

Target Audience

This course is designed for quality assurance officers, production supervisors, and technical staff working in pharmaceutical manufacturing. It is also suitable for new entrants seeking to understand QA fundamentals in the pharmaceutical sector.

Prerequisites

None — open enrollment. However, prior experience in a pharmaceutical or manufacturing environment is beneficial.

Course Outline

Practicals

Overview

Practicals reinforce theoretical knowledge through hands-on exercises in documentation, sampling, validation, and auditing. Learners apply GMP principles in simulated manufacturing scenarios to develop practical skills essential for QA roles.

Practical Activities

• SOP Writing and Document Review — Learners write a standard operating procedure and then peer-review another SOP using GDP criteria. (4h)
• Sampling and QC Testing Simulation — Learners perform simulated sampling of raw materials and finished products, then conduct basic physical tests and record results. (5h)
• Validation Protocol Development — Teams develop a process validation protocol for a tablet manufacturing step, including acceptance criteria and sampling plan. (4h)
• Mock Internal Audit — Learners conduct a mock audit of a simulated manufacturing area using a checklist, then report findings and propose CAPAs. (5h)
• Batch Record Review and OOS Investigation — Learners review a completed batch record for errors and simulate an OOS investigation using root cause analysis tools. (3h)

Summatives

Each delegate is assessed continuously throughout the course via daily exercises, scored practical assignments, and a final summative test at the end.

Practical Assignments — 30%

Practical assignments are observed and scored against a rubric during the practical sessions. Each delegate's practical mark is averaged into a single 100% score and contributes 30% to the final total.

Daily Exercises — 20%

Every training day ends with a multiple-choice exercise scored out of 100%. The scores from each daily exercise are averaged across the duration of the course to produce a Daily Average mark, which contributes 20% to the final total.

Final Test — 50%

On the last day a final summative test is written. It is a multiple-choice paper with multiple-answer questions: each question may have more than one correct option, and a single wrong selection on a question marks the entire question wrong — no partial credit. The final test is scored out of 100% and contributes 50% to the overall mark.

Final Total

Component	Out of	Weight
Practical Assignments (rubric-scored)	100%	30%
Daily Average (multiple choice)	100%	20%
Final Test (multi-answer multiple choice)	100%	50%
Final Total	—	100%

All marks are recorded on the AATICD LMS and visible to each learner under their account.

Certificate

How it works

• Certificates are auto-generated on the AATICD LMS as soon as the marks pass the 50% threshold.
• Each certificate is a branded PDF with the delegate's name, the course title, the unit standard ID, NQF level, credits, and the date of issue.
• You can download or print your certificate from your LMS dashboard at any time after issue — there's no reissue fee and no expiry date.
• If you scored under 50% you can sit the final test again at the next scheduled session at no extra cost.

Where to find it

Sign in to the LMS, open your dashboard, and your certificates appear under My Certificates. Each entry has a View / Download button and a print option.

Training Discounts

Group discounts apply automatically — the more delegates you enrol, the greater the saving. Discounts are calculated at 3% per 5 delegates, scaling up to 40% off for 100+ delegates.

Delegates	Discount
5	3% off
10	6% off
15	9% off
20	12% off
25	15% off
30	18% off
50	30% off
75	35% off
100	40% off

3% discount per 5 delegates, up to 40% off for 100+ delegates. Contact us for a custom group quote.