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 produce clear, accurate technical reports and apply statistical analysis in a regulated environment. It ensures compliance with industry standards and enhances decision-making through data-driven insights.

Learning Outcomes

  • Apply principles of technical writing to structure clear and concise pharmaceutical reports.
  • Analyze data sets using appropriate statistical methods to support conclusions.
  • Evaluate the validity of statistical results in the context of pharmaceutical quality control.
  • Design report formats that comply with regulatory requirements (e.g., GMP, ICH).
  • Implement data presentation techniques to effectively communicate findings.
  • Demonstrate proficiency in interpreting statistical outputs for decision-making.

Target Audience

Pharmaceutical scientists, quality assurance officers, regulatory affairs specialists, and laboratory technicians who need to write technical reports and perform statistical analysis as part of their daily duties.

Prerequisites

None — open enrollment. However, a basic understanding of pharmaceutical processes is recommended.

Course Outline

Day 1: Foundations of Technical Report Writing in Pharmaceuticals

Objectives:
• Understand the principles of technical writing in a pharmaceutical context.
• Identify the structure and key components of a technical report.
• Apply proper grammar, tone, and clarity for scientific documentation.
• Recognise regulatory and quality standards (e.g., GMP, GLP) impacting reports.

Topics:
• Introduction to technical report writing in pharmaceuticals.
• Characteristics of effective technical writing: clarity, accuracy, conciseness.
• Standard report structure: title, abstract, introduction, methods, results, discussion, conclusion, references.
• Language and style: avoiding ambiguity, using passive voice appropriately.
• Overview of regulatory requirements (FDA, SAHPRA, ICH guidelines).
• Common pitfalls in pharmaceutical writing.

Day 2: Statistical Foundations for Pharmaceutical Analysis

Objectives:
• Understand basic statistical concepts relevant to pharmaceutical data.
• Differentiate between descriptive and inferential statistics.
• Apply common statistical tests for hypothesis testing.
• Interpret p-values, confidence intervals, and effect sizes.

Topics:
• Types of data: continuous, categorical, ordinal.
• Descriptive statistics: mean, median, standard deviation, variance.
• Probability distributions: normal, binomial, Poisson.
• Hypothesis testing: null and alternative hypotheses, Type I and II errors.
• Common tests: t-test, chi-square, ANOVA, correlation.
• Confidence intervals and p-values.
• Introduction to statistical software (e.g., Excel, Minitab).

Day 3: Data Presentation and Graphical Methods

Objectives:
• Create effective tables and graphs for pharmaceutical data.
• Apply principles of data visualisation to enhance report clarity.
• Interpret graphical outputs and link to statistical findings.
• Avoid misleading representations.

Topics:
• Principles of data visualisation: simplicity, accuracy, clarity.
• Tables: formatting, labelling, and summarising data.
• Graphs: bar charts, histograms, scatter plots, box plots, line graphs.
• Using statistical software to generate graphics.
• Common errors in graphical presentation.
• Integrating figures and tables into a report.

Day 4: Writing the Statistical Analysis Section

Objectives:
• Draft a comprehensive statistical analysis section for a pharmaceutical report.
• Describe statistical methods clearly and accurately.
• Report results with appropriate tables and figures.
• Discuss findings in context of regulatory expectations.

Topics:
• Structure of the statistical analysis section.
• Describing study design and data collection methods.
• Specifying statistical tests and software used.
• Presenting results: tables, figures, and narrative.
• Interpreting results for a technical audience.
• Writing discussion and conclusions based on statistical evidence.
• Case study: reviewing a sample report.

Day 5: Integrating Report Writing and Statistics – Practical Application

Objectives:
• Produce a complete technical report incorporating statistical analysis.
• Apply quality checks and peer review processes.
• Understand the role of documentation in regulatory submissions.
• Demonstrate competence in writing and statistical interpretation.

Topics:
• Final project: writing a full technical report from provided data.
• Peer review and feedback session.
• Revision and editing techniques.
• Regulatory documentation: common formats (e.g., CTD).
• Best practices for archiving and version control.
• Course wrap-up and assessment.

Practicals

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

Hands-on practicals are integrated throughout the course to reinforce theoretical concepts. Learners will use statistical software to analyse datasets, create graphs, and write report sections, culminating in a complete technical report.

Practical Activities
  • Practical 1: Descriptive Statistics and Graphs — Learners use Excel or Minitab to compute descriptive statistics and create histograms, box plots, and scatter plots from provided pharmaceutical data. (3h)
  • Practical 2: Hypothesis Testing — Learners perform t-tests, chi-square tests, and ANOVA on sample datasets, interpreting p-values and confidence intervals. (4h)
  • Practical 3: Writing the Methods and Results Sections — Learners draft the statistical methods and results sections of a report, incorporating tables and figures from previous practicals. (4h)
  • Practical 4: Full Report Compilation and Peer Review — Learners compile a complete technical report from a case study, then participate in peer review to provide feedback. (4h)

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
Mon 21 Jun 2027 Fri 25 Jun 2027 Virtual Winter 2027 $1,242 Register
Mon 05 Jul 2027 Fri 09 Jul 2027 Virtual Winter 2027 $1,242 Register
Mon 06 Sep 2027 Fri 10 Sep 2027 Virtual Spring 2027 $1,242 Register
Mon 20 Sep 2027 Fri 24 Sep 2027 Virtual Spring 2027 $1,242 Register
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 424 sessions across 26 venues
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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
Mon 17 Aug 2026 Fri 21 Aug 2026 Shenzhen, China Winter 2026 $7,398 Register
Mon 24 Aug 2026 Fri 28 Aug 2026 Bangkok, Thailand Winter 2026 $6,318 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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