The aim of studying and bibliography

The main aim of study: The aim of the course is to gain knowledge about the validation of industrial processes and statistical tools used in the process of validation

The general information about the module: The module is implemented in the 2nd semester and includes 15 hours of exercises. The module ends with a pass.

Teaching materials: Materiały dydaktyczne opublikowane na stronach Zakładu Informatyki Chemicznej

Bibliography required to complete the module

Bibliography used during lectures

1

B. Dębska, B.Guzowska-Świder

Statystyka i opracowanie wyników

Oficyna wydawnicza Politechniki Rzeszowskiej.

2011

Bibliography to self-study

1	J. Czermiński, A. Iwasiewicz, Z. Paszek, A. Sikorski	Metody statystyczne w doświadczalnictwie chemicznym	WNT, Warszawa.	1984
2	S. Ł. Achnazarowa, W.W. Kafarow	Optymalizacja eksperymentu w chemii i technologii chemicznej	WNT, Warszawa.	1982
3	B. Dębska, B. Guzowska-Świder	kurs Statystyka	www.e-chemia.pl.	2011

Basic requirements in category knowledge/skills/social competences

Formal requirements: Basic knowledge of statistics and results elaboration

Basic requirements in category knowledge: Basic knowledge of statistics

Basic requirements in category skills: computer literacy

Basic requirements in category social competences:

Module outcomes

MEK	The student who completed the module	Types of classes / teaching methods leading to achieving a given outcome of teaching	Methods of verifying every mentioned outcome of teaching	Relationships with KEK	Relationships with PRK
01	Is able to plan, optimize and evaluate the experiment.	lab	written test, observation of performance, written report	K_W02+ K_U08+ K_U14+	P7S_UW P7S_WG
02	He can use statistical tools in the validation process. He can analyze the critical process parameters	lab	written test, observation of performance, written report	K_W03+++ K_U07++ K_U14+	P7S_UW P7S_WG
03	He can perform an analysis of the homogeneity and stability testing facilities. He can perform an analysis of the effectiveness of process changes based on the control charts.	lab	written test, observation of performance, written report	K_U01+ K_U14+	P7S_UW

Attention: Depending on the epidemic situation, verification of the achieved learning outcomes specified in the study program, in particular credits and examinations at the end of specific classes, can be implemented remotely (real-time meetings).

The syllabus of the module

Sem.	TK	The content	realized in	MEK
2	TK01	Design of experiments	C01	MEK01 MEK02
2	TK02	Statistical tools in the validation process. Descriptive statistics. Normality tests. Rejecting outliers.	C02 - C03	MEK02 MEK03
2	TK03	Linearity validated processes and methods. Linear Regression. The limit of detection and quantification. Analysis of critical process parameters. Selectivity, accuracy, reproducibility, recovery, range of methods. The release profiles.	C04 - C05	MEK02 MEK03

The student's effort

The type of classes	The work before classes	The participation in classes	The work after classes
Laboratory (sem. 2)	The preparation for a Laboratory: 5.00 hours/sem.	contact hours: 15.00 hours/sem.
Advice (sem. 2)		The participation in Advice: 5.00 hours/sem.
Credit (sem. 2)		The written credit: 1.00 hours/sem.

The way of giving the component module grades and the final grade

The type of classes	The way of giving the final grade
Laboratory	Computer laboratory: credit on the basis of the tasks performed
The final grade	The average of the grades obtained in individual laboratories.

Sample problems

Required during the exam/when receiving the credit
(-)

Realized during classes/laboratories/projects
(-)

Others
(-)

Can a student use any teaching aids during the exam/when receiving the credit : no

The contents of the module are associated with the research profile: no