Technical Report Writing and Statistical Analysis for the Pharmaceutical Industry

Why Attend

Clear, unambiguous technical reports and procedures are of vital importance in the pharmaceutical industry. They are used to communicate the outcomes of product development work and investigations and may be reviewed by the FDA, or other regulatory bodies if they form part of a regulatory submission. On this course, participants will learn how to analyze and present technical data in a clear and concise manner. They will produce powerful charts and graphs using the graphics tools in Microsoft Excel® and will design compelling tables making data comparison a powerful tool for the target audience. Important statistical methods such as evaluation of outliers, analysis of variance, experimental design and estimation of uncertainty will be covered. The elements of effective standard operating procedures will also be explained.

Course Methodology

The material used in the training course will be based on exercises as well as regional and international case studies. Participants will frequently work in pairs as well as in larger teams.

Participants will have the opportunity to practice their new set of skills in technical report writing. They will be given the option to work on a report using data from their workplace or use model data supplied by the trainer.

Course Objectives

By the end of the course, participants will be able to:

  • Write effective technical reports and procedures that cater to the needs of their target audience
  • Present complex experimental data in a logical, clear and concise manner making optimal use of graphs, charts, and tables
  • Build credibility by following the conventions of scientific writing to support explanations and arguments
  • Ensure technical documents achieve maximum impact by efficiently structuring the data and avoiding common written English mistakes
  • Analyze experimental data using the principles of statistical analysis

Target Audience

This course is designed for pharmaceutical professionals tasked with data analysis and/or producing technical reports and procedures. It will be particularly beneficial for research and development (R&D) analysts/ managers, scientists, engineers, and technicians as well as Quality Assurance (QA), Information Technology (IT), manufacturing, and other operations professionals. This course will also prove useful for administrative staff supporting the R&D and operations activities by preparing technical documentation.

Target Competencies

  • Technical Procedure Writing
  • Technical Report Writing
  • Statistical Analysis
  • Technical Data Presentation
  • Technical Language

Location:

South Africa

Training Dates:


Training Schedule
Duration
1 Week
2 Weeks
3 Weeks
Month
Option A
Option B
Option A
Option B
Option A
January
13 - 17 Jan
27 Jan - 31 Jan
6 - 17 Jan
20 Jan- 31 Jan
13 Jan - 31 Jan
February
10 - 14 Feb
24 Feb - 29 Feb
3 - 14 Feb
17 Feb - 29 Feb
10 Feb - 29 Feb
March
10 - 14 Mar
23 - 27 Mar
2 - 13 Mar
16 - 27 Mar
9 - 27 Mar
April
6 - 10 Apr
20 - 24 Apr
30 Mar - 10 Apr
13 - 24 Apr
6 - 24 Apr
May
6 - 10 May
27 -31 May
29 Apr - 10 May
20 - 31 May
13 - 31 May
June
8 - 12 Jun
22 - 26 Jun
1 -12 Jun
15 - 26 Jun
8 - 26 Jun
July
6 - 10 Jul
20 - 24 Jul
29 Jun - 10 Jul
13 - 24 Jul
6 - 24 Jul
August
10 - 14 Aug
24 - 28 Aug
3 - 14 Aug
17 - 28 Aug
10 - 28 Aug
September
7 - 11 Sep
21 - 25 Sep
31Aug - 10 Sep
14 - 25 Sep
7 - 25 Sep
October
5 - 9 Oct
19 - 23 Oct
28 Sep - 9 Oct
12 - 23 Oct
5 - 23 Oct
November
9 - 13 Nov
23 - 27 Nov
02 - 13 Nov
16 - 27 Nov
9 - 27 Nov
December
7 - 11 Dec
14 - 18 Dec
30 Nov - 11 Dec
07 - 18 Dec
30 Nov - 18 Dec


Course Duration:

Unit Standard:

NQF Level:

Number of Credits:


Course Fees


Note: Please fill in the online application form on the left or bottom if this page to receive a quotation with detailed pricing from AATICD.

How to Apply:

To Apply Simply Fill in the Online Enquiries / Applications form on the Right Sidebar or Bottom of this website https://www.aaticd.co.za

NB:

When filling the online application form; please take note of your desired Training Month, Duration in Weeks and Training Session. This will give us the exact dates you will be attending your classes.

Also note that Tuition Fees must be paid upfront on or before training start date. This is to ensure that all resources are made availabe for you before you start. You will not be allowed into training if fees are not paid and verified.

Also note that Tuition Fees Cancellations must be made 14 business working days before the starting date of training. This will allow us to do a 50% refund of the total amount paid. If cancellations are made thereafter note that no refund will be made to delegates.

Tuition Fees include teas and lunch as well as either a laptop or tablet which a delegate will take home free of charge.

Tuition Fee DOES NOT include Accommodation, Dinners and other Extra Curricular Activities or Incidentals. Delegates are expected to fund this on their own. AATICD will not be held accountable for any incidents to delegates.

In-House Trainings are also available for 3 or more delegates for any duration. Please consult with our Administration for such In-House training bookings.


Course Outline

  • Scientific writing
    • Organization and structure of technical reports
    • Conventions and style in scientific writing
    • Correct use of English
      • Common mistakes
      • Verbs, nouns, prepositions, and adjectives
      • Punctuation
    • Length and structure of sentences and paragraphs
    • Figures and tables
    • Citing scientific literature
  • Statistical methods
    • Distributions and types of data
    • Basic statistical techniques
    • Outliers
    • Analysis of variance
    • Experimental design
    • Estimates of measurement uncertainty
    • Rules governing the use of statistical techniques in pharmaceutical QC
  • Graphical representation of data
    • Options for presenting data in technical reports
    • Designing effective tables
    • Optimal types of graphs
      • Scatter graphs: linear and non-linear
      • Pie charts
      • Bar/column graphs
      • Radar plots
    • Use of error bars
    • Graphics tools in Microsoft Excel®
  • Writing effective procedures
    • Definitions of a Standard Operating Procedure (SOP)
    • Best practice in SOP writing
    • The importance of brevity and clarity
    • Organization and structure of an SOP
    • Use of figures and diagrams
    • Point-of-use aids in compliance