Pharmaceutical Lab Academy
for
Training and Consultation
Technical Proposal for Training Course
Statistical Quality Control (SQC): The Essential Science to All
Background
Statistics as a science may not be interesting for many Non-Statistician Users like
us; the reason for that is the complex calculation formulae upon which it is based.
However, it is an indispensable science for all the personnel working in the field of
pharmaceutical industry; especially for those working in the technical sectors.
On one hand, Statistical Terms are scattered in almost all the technical documents
we deal with on a daily basis such as Pharmacopoeias, WHO-, ICH-, FDA-, and
EMEA-guidelines.
On the other hand, Several Studies requested by the regulatory authorities; e.g.
EDA, and conducted to satisfy the cGMP requirements such as Process Validation,
Annual Product Review, Stability Studies, etc. involve many Statistical
Calculations.
No doubt that the Statistics-knowledgeable person will certainly have a clearer
and deeper understanding of such guidelines and a more perfect/professional
implementation of Statistics while conducting these studies compared with the one
who is not knowledgeable about.
With the advent of many well-designed statistical software packages like Minitab,
such tedious calculations can be easily done in no time; i.e., just point-and-click.
Thus, many Non-Statistician Users of Statistics think that learning such a difficult
science will add no value to them which is surely untrue; as they are still in dire
need to understand the Physical/Tangible Meaning of the results they have
obtained for the purpose of their perfect interpretation.
Pharmaceutical Lab Academy
for
Training and Consultation
Who should attend?
This course is designed to be suitable for Non-Statistician Users of Statistics like:
Quality Assurance Personnel;
Research and Development (R&D) Personnel;
Quality Control Personnel;
Methodology Personnel;
Stability Personnel;
Personnel of Private MOH-accredited Laboratories;
Others using (or interested in studying) this science.
Intended Learning Objectives
This course is tailored to make Non-Statistician Participants be familiar
with Statistics, in general, and to apply this science in their specific fields
in the Pharmaceutical Industry through:
Illustrating the Physical Meaning(s) of the most commonly-used Statistical
Terms;
Discussing how to present Data Numerically and Graphically;
Discussing the applications of Inferential Statistics in Pharmaceutical Industry;
Handling the practical applications of Statistics in various Pharmaceutical
Studies.
Course Outlines
Over five days, the following subtopics are to be covered in sufficient detail:
1. Fundamentals of Statistics including the Basic Definitions such as Branches
of Statistics (Descriptive and Inferential Statistics), Types of Variables,
Population and Sample Concepts, Sampling Plans, and Others;
2. Numerical and Graphical Data Presentation in a manner that enables their
Organization and Summarization;
3. Detailed Discussion of the Normal Distribution as being the most-commonly
used (and assumed) probability distribution in Pharmaceutical Statistics;
Pharmaceutical Lab Academy
for
Training and Consultation
4. Statistical Inference and Making Estimates of the Truth: Confidence Levels,
Limits, Intervals, Tolerance Limits as a Means to Draw Conclusions on
a Large Batch based on the Results of a Small Sample;
5. Hypothesis Testing as a Tool to Approve or Disprove Hypotheses in Practice;
6. Tests to Identify Differences: One-Sample t-test, Two-Sample t-test, Paired
t-test, and One-Way Analysis of Variance (ANOVA);
7. Tests to Evaluate Relationships: Linear Regression and Calibration Curve
Statistics;
8. Statistical Process Control (SPC) through the use of Different Types of
Control Charts for Variables and Attributes;
9. Practical Implementation of Statistics in Pharmaceutical Industry such as
Process Validation to determine Process Capability, Annual Product Review,
Stability Studies, Analytical Procedure Validation, Statistical Tools for
Specifications, and Others.
NOTE: Minitab Statistical Software will be used throughout the Course to
demonstrate Statistical Applications in the Pharmaceutical Industry.
Trainer
Dr. Mohammed Fadel with about 20 years’ experience in Pharmaceutical
Industry, 12 years’ experience in Pharmaceutical Field Training, and 9 years’
experience in Translation Field (Translation and Teaching).
Training Material and Certification
- Each Trainee will be given the presentation in the form of a printed handout.
- Each Trainee will be given a Certificate of Achievement at the end of the
course.
Course Duration
5 Days (Full Day: 9:00 am – 4:00 pm)
Dr. Mohammed Fadel
PLA Trainer and Managing Director
