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Lecturer(s)
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Pavlačková Jana, Ing. Ph.D.
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Course content
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1. History, structure and creation of legal regulations. 2. Regulation No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). Act No. 350/2011 Coll., On chemical substances and chemical and chemical mixtures. Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures (CLP Regulation). 3. Act No. 258/2000 Coll. Public Health Protection Act as amended. Act No. 102/2001 Coll., On general product safety, as amended, Act No. 634/1992 Coll., On consumer protection, as amended. 4. Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, Commission Regulation (EU) 655/2013. 5. Certification of natural cosmetics and organic cosmetics CPK standards. 6. Regulation 648/2004 / EC of the European Parliament and of the Council on detergents. 7. Legislation for medical devices and biomaterials used in them. Act No. 22/1997 Coll., On technical requirements for products and on amendments to certain acts, as amended. 8. Act No. 268/2014 Coll., On medical devices. 9. Government Regulation No. 54/2015 Coll., On technical requirements for medical devices, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. 10. Conformity assessment of medical devices, product certification and conformity assessment, CE mark. 11. Principles of certification, pyramid of documents in QMS, controlled documents, principles of quality audits. 12. Quality systems according to the ČSN EN ISO 9001 standard. 13. SMJ for medical devices - ČSN EN ISO 13485. 14. ČSN EN ISO 22716 Cosmetics - Good Manufacturing Practice (GMP) - Guidelines for Good Manufacturing Practice.
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Learning activities and teaching methods
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Lecturing
- Preparation for course credit
- 90 hours per semester
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| learning outcomes |
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| Knowledge |
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| to explain the structure and development of Czech and EU legislation |
| to explain the structure and development of Czech and EU legislation |
| to characterize in the legal regulations of public health protection and product safety |
| to characterize in the legal regulations of public health protection and product safety |
| to characterize the regulatory chemical legislation considered in the field of cosmetic products and in relation to them |
| to characterize the regulatory chemical legislation considered in the field of cosmetic products and in relation to them |
| to define the objectives, rules and terminology of the legislation on cosmetic products placed on the market |
| to define the objectives, rules and terminology of the legislation on cosmetic products placed on the market |
| to define the objectives, rules and terminology of medical device legislation |
| to define the objectives, rules and terminology of medical device legislation |
| to define quality management systems in the field of cosmetic products and medical devices |
| to define quality management systems in the field of cosmetic products and medical devices |
| Skills |
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| to suggest the principles of personal and operational hygiene for the production of cosmetic products and the performance of cosmetic services |
| to suggest the principles of personal and operational hygiene for the production of cosmetic products and the performance of cosmetic services |
| to search and identify information on ingredients and their functions in cosmetic formulas |
| to search and identify information on ingredients and their functions in cosmetic formulas |
| to suggest areas of information to ensure the Cosmetic Product Safety Report and its notification |
| to suggest areas of information to ensure the Cosmetic Product Safety Report and its notification |
| to suggest a procedure for reporting a serious undesirable effect |
| to suggest a procedure for reporting a serious undesirable effect |
| to suggest a procedure for product certification |
| to suggest a procedure for product certification |
| to suggest activities resulting from good manufacturing practice to obtain a quality product with defined characteristics |
| to suggest activities resulting from good manufacturing practice to obtain a quality product with defined characteristics |
| to match bounderline products according to definitions |
| to match bounderline products according to definitions |
| to classify medical devices according to the rules into classification classes |
| to classify medical devices according to the rules into classification classes |
| teaching methods |
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| Knowledge |
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| Lecturing |
| Lecturing |
| Methods for working with texts (Textbook, book) |
| Methods for working with texts (Textbook, book) |
| Skills |
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| Dialogic (Discussion, conversation, brainstorming) |
| Dialogic (Discussion, conversation, brainstorming) |
| Practice exercises |
| Practice exercises |
| assessment methods |
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| Knowledge |
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| Didactic test |
| Didactic test |
| Grade (Using a grade system) |
| Grade (Using a grade system) |
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Recommended literature
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Good Laboratory Practice: OECD Principles and Guidance for Compliance Monitoring. Paris: OECD, 2005. ISBN 9789264012820.
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Legislativní dokumenty dostupné viz http://aplikace.mvcr.cz/sbirka-zakonu/ a http://eur-lex.europa.eu/homepage.html.
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SDĚLENÍ ORGÁNŮ, INSTITUCÍ A JINÝCH SUBJEKTŮ EVROPSKÉ UNIE - EVROPSKÁ KOMISE - SDĚLENÍ KOMISE ?Modrá příručka? k provádění pravidel EU pro výrobky 2016 (Text s významem pro EHP) (2016/C 272/01).
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BECKOVÁ, M. Revize ISO 9001:2015: Jak aktualizovat stávající systém managementu kvality?. Praha: Verlag Dashöfer, 2016. ISBN 978-80-87963-22-7.
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Blecharz, P. Základy moderního řízení kvality. Praha: Ekopress, 2011.
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HNÁTEK, J. Komentované vydání ČSN EN ISO 9001:2016 Systémy managementu kvality - Požadavky. Praha: Česká společnost pro jakost. 2016. ISBN 978-80-02-02642-6.
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NENADÁL, J. Systémy managementu kvality: co, proč a jak měřit?. Praha: Management Press, 2016. ISBN 978-80-7261-426-4.
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