Custom Courses Health, Safety and Environment (HSE)

Technical Report Writing and Statistical Analysis for Pharmaceuticals Training

SAQA US AATICD-0060 | NQF 5 | Credits 10 | Duration 5 Days
From $1,242 per delegate

Description

This course equips pharmaceutical professionals with the skills to write clear, compliant technical reports and perform statistical analyses essential for quality control, regulatory submissions, and process validation. Participants will learn to structure data-driven reports and apply basic statistical methods to ensure accuracy and regulatory adherence.

Learning Outcomes

  • Apply principles of technical report writing to structure pharmaceutical documentation clearly and logically.
  • Analyze pharmaceutical data using descriptive and inferential statistical methods.
  • Evaluate data integrity and identify trends or deviations in manufacturing and quality control processes.
  • Design technical reports that meet regulatory standards (e.g., SAHPRA, ICH, WHO) and organizational requirements.
  • Implement statistical process control techniques to monitor and improve pharmaceutical production.
  • Demonstrate proficiency in interpreting statistical outputs and communicating findings to diverse stakeholders.

Target Audience

Quality assurance officers, regulatory affairs specialists, laboratory analysts, and production supervisors in the pharmaceutical industry who need to produce technical reports and analyze data for compliance and decision-making.

Prerequisites

Basic understanding of pharmaceutical manufacturing processes and familiarity with data handling. No prior statistical training required.

Course Outline

Day 1: Principles of Technical Report Writing

Objectives:
• Understand the purpose and audience of technical reports in the pharmaceutical industry.
• Identify the structure and key components of a technical report.
• Apply principles of clear, concise, and objective writing.
• Recognise common errors in technical writing and how to avoid them.
• Use appropriate terminology and referencing in pharmaceutical contexts.

Topics:
• Introduction to technical report writing in pharmaceuticals.
• Audience analysis and purpose definition.
• Structure of a technical report: title, abstract, introduction, methods, results, discussion, conclusion, references.
• Writing clearly and concisely: avoiding jargon, ambiguity, and redundancy.
• Using data and evidence to support claims.
• Referencing and citation standards (e.g., Vancouver style).
• Common pitfalls and how to avoid them.
• Exercises: critiquing sample reports.

Day 2: Statistical Foundations for Pharmaceutical Data

Objectives:
• Understand basic statistical concepts relevant to pharmaceutical analysis.
• Differentiate between descriptive and inferential statistics.
• Perform calculations for measures of central tendency and dispersion.
• Interpret graphical representations of data.
• Apply probability distributions commonly used in pharmaceuticals.

Topics:
• Overview of statistics in pharmaceuticals: quality control, clinical trials, stability studies.
• Types of data: nominal, ordinal, interval, ratio.
• Descriptive statistics: mean, median, mode, range, variance, standard deviation.
• Graphical methods: histograms, box plots, scatter plots, control charts.
• Probability distributions: normal, binomial, Poisson.
• Introduction to hypothesis testing: null and alternative hypotheses, p-values.
• Exercises: manual calculations and interpretation of outputs.

Day 3: Advanced Statistical Methods and Software Application

Objectives:
• Apply hypothesis testing for means, proportions, and variances.
• Perform t-tests, ANOVA, chi-square tests, and regression analysis.
• Use statistical software (e.g., Excel, Minitab, or R) for analysis.
• Interpret statistical output and draw valid conclusions.
• Understand the role of sample size and power analysis.

Topics:
• Hypothesis testing: one-sample, two-sample, paired t-tests.
• Analysis of variance (ANOVA): one-way and two-way.
• Chi-square tests for categorical data.
• Correlation and simple linear regression.
• Introduction to non-parametric tests.
• Sample size determination and power analysis.
• Using statistical software: data entry, analysis, and output interpretation.
• Exercises: computer-based statistical analysis.

Day 4: Integrating Statistics into Technical Reports

Objectives:
• Present statistical results effectively in tables, figures, and text.
• Write clear and accurate statistical methods and results sections.
• Avoid common mistakes in reporting statistical data.
• Apply guidelines for reporting in pharmaceutical contexts (e.g., ICH, CONSORT).
• Critically evaluate statistical reporting in sample reports.

Topics:
• Best practices for presenting statistical results.
• Writing the methods section: describing statistical tests, software, and assumptions.
• Writing the results section: textual summary, tables, and figures.
• Common errors: misuse of p-values, ignoring assumptions, overinterpretation.
• Regulatory guidelines: ICH E9, CONSORT for clinical trials.
• Case studies: reviewing and improving statistical reporting.
• Exercises: drafting methods and results sections.

Day 5: Comprehensive Report Writing and Peer Review

Objectives:
• Compile a complete technical report integrating statistical analysis.
• Apply peer review techniques to evaluate and improve reports.
• Revise reports based on feedback.
• Understand the importance of ethical reporting and data integrity.
• Prepare for real-world pharmaceutical reporting tasks.

Topics:
• Step-by-step report compilation from raw data to final document.
• Peer review process: constructive feedback and revision.
• Ethical considerations: data fabrication, plagiarism, conflicts of interest.
• Quality assurance in report writing: checklists and standard operating procedures.
• Final project: producing a complete technical report.
• Presentation and discussion of reports.
• Course wrap-up and resources for continued learning.

Practicals

16 hours of practicals To be conducted online or on-campus or in-house
Overview

Practical sessions provide hands-on experience with statistical software and real pharmaceutical datasets. Learners will perform statistical analyses, create graphical presentations, and write corresponding report sections, culminating in a complete technical report.

Practical Activities
  • Statistical Software Orientation — Learners install/access statistical software (Excel, Minitab, or R) and perform basic data entry, descriptive statistics, and graphing. (2h)
  • Hypothesis Testing and ANOVA — Learners conduct t-tests, ANOVA, and chi-square tests on provided pharmaceutical datasets and interpret results. (4h)
  • Regression Analysis and Reporting — Learners perform simple linear regression, check assumptions, and write the methods and results sections for a regression analysis. (4h)
  • Complete Report Drafting and Peer Review — Learners compile a full technical report from a given dataset, including all sections, then participate in peer review and revision. (6h)

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

Certificate of Completion

Awarded to delegates who achieve an overall mark of 50% or higher on the Final Total (Practicals 30% + Daily Average 20% + Final Test 50%).

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.

Upcoming Training Sessions
Online training — attend live sessions from anywhere via our virtual classroom.
Start End Delivery Season Price Action
Mon 07 Sep 2026 Fri 11 Sep 2026 Virtual Spring 2026 $1,242 Register
Mon 21 Sep 2026 Fri 25 Sep 2026 Virtual Spring 2026 $1,242 Register
Mon 05 Oct 2026 Fri 09 Oct 2026 Virtual Spring 2026 $1,242 Register
Mon 07 Dec 2026 Fri 11 Dec 2026 Virtual Summer 2026 $1,242 Register
Mon 04 Jan 2027 Fri 08 Jan 2027 Virtual Summer 2026 $1,242 Register
Mon 01 Feb 2027 Fri 05 Feb 2027 Virtual Summer 2026 $1,242 Register
Mon 01 Mar 2027 Fri 05 Mar 2027 Virtual Autumn 2027 $1,242 Register
Mon 07 Jun 2027 Fri 11 Jun 2027 Virtual Winter 2027 $1,242 Register
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Mon 06 Sep 2027 Fri 10 Sep 2027 Virtual Spring 2027 $1,242 Register
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Mon 04 Oct 2027 Fri 08 Oct 2027 Virtual Spring 2027 $1,242 Register
Mon 06 Dec 2027 Fri 10 Dec 2027 Virtual Summer 2027 $1,242 Register
Mon 20 Dec 2027 Fri 24 Dec 2027 Virtual Summer 2027 $1,242 Register
Mon 03 Jan 2028 Fri 07 Jan 2028 Virtual Summer 2027 $1,242 Register
On-Campus training — face-to-face sessions at our training venues across Africa and beyond.
Showing all 426 sessions across 26 venues
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Mon 03 Aug 2026 Fri 07 Aug 2026 Pretoria, South Africa Winter 2026 $1,863 Register
Mon 03 Aug 2026 Fri 07 Aug 2026 Dubai, UAE Winter 2026 $5,238 Register
Mon 10 Aug 2026 Fri 14 Aug 2026 Durban, South Africa Winter 2026 $2,916 Register
Mon 10 Aug 2026 Fri 14 Aug 2026 Abu Dhabi, UAE Winter 2026 $5,238 Register
Mon 17 Aug 2026 Fri 21 Aug 2026 Harare, Zimbabwe Winter 2026 $3,078 Register
In-House training — we bring the trainer to your organisation, tailored to your team.
Start End Delivery Season Price Action
Mon 14 Sep 2026 Fri 18 Sep 2026 Your Premises Spring 2026 $1,615 Register
Mon 28 Sep 2026 Fri 02 Oct 2026 Your Premises Spring 2026 $1,615 Register
Mon 12 Oct 2026 Fri 16 Oct 2026 Your Premises Spring 2026 $1,615 Register
Mon 14 Dec 2026 Fri 18 Dec 2026 Your Premises Summer 2026 $1,615 Register
Mon 11 Jan 2027 Fri 15 Jan 2027 Your Premises Summer 2026 $1,615 Register
Mon 08 Feb 2027 Fri 12 Feb 2027 Your Premises Summer 2026 $1,615 Register
Mon 08 Mar 2027 Fri 12 Mar 2027 Your Premises Autumn 2027 $1,615 Register
Mon 14 Jun 2027 Fri 18 Jun 2027 Your Premises Winter 2027 $1,615 Register
Mon 28 Jun 2027 Fri 02 Jul 2027 Your Premises Winter 2027 $1,615 Register
Mon 12 Jul 2027 Fri 16 Jul 2027 Your Premises Winter 2027 $1,615 Register
Mon 13 Sep 2027 Fri 17 Sep 2027 Your Premises Spring 2027 $1,615 Register
Mon 27 Sep 2027 Fri 01 Oct 2027 Your Premises Spring 2027 $1,615 Register
Mon 11 Oct 2027 Fri 15 Oct 2027 Your Premises Spring 2027 $1,615 Register
Mon 13 Dec 2027 Fri 17 Dec 2027 Your Premises Summer 2027 $1,615 Register
Mon 27 Dec 2027 Fri 31 Dec 2027 Your Premises Summer 2027 $1,615 Register
Mon 10 Jan 2028 Fri 14 Jan 2028 Your Premises Summer 2027 $1,615 Register
Training Discounts
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% off per 5 delegates, up to 40% for 100+

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