IC024 QC in analytical chemistry

Faculty of Science
Autumn 2008
Extent and Intensity
0/0. 1 credit(s). Type of Completion: zk (examination).
Guaranteed by
prof. RNDr. Přemysl Lubal, Ph.D.
Department of Chemistry – Chemistry Section – Faculty of Science
Prerequisites
Basic knowledge of analytical chemistry, statistics and chemometrics.
Course Enrolment Limitations
The course is offered to students of any study field.
Course objectives
See sylabus. The lecture will take place in room AK1 (Faculty of Medicine, MU, Komenskeho square 2) on Wed 26.11. at 8:30-17:00.
Syllabus
  • Validation overview - the need for validation. The history and development of validation - what validation is and how it operates. Analytical method validation. The eight steps involved Validation Master Plan (VMP). What the VMP is and the necessity for a VMP Equipment Qualification. Installation Qualification (IQ). Performance Qualification (PQ). Operational Qualification (OQ). Cleaning validation. The basics of cleaning validation. Manual versus clean in place (CIP) methods. Detergents. Process Analytical Technology (PAT). What is PAT? Why is it so important now? Advantages and disadvantages of adopting PAT. Medical Device Directive. What the medical device directive is What the requirements to meet it are. How to obtain a CE mark. Quality Assurance (QA), Quality Control (QC),Good Manufacturing Practice (GMP) Code of Federal Regulations, Q7A. Explanation of what QA, QC and GMP are and their inter-relationship. Sources of information. ISO 9000 and ISO 1348. ISO 9001:2000 deals with quality management systems. ISO 13485 adopts ISO9000 to deal with medical devices. Biomedical devices. Past, present and the future
Language of instruction
English
Further comments (probably available only in Czech)
The course is taught: in blocks.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/sci/autumn2008/IC024