Lernkarten

Karten 135 Karten
Lernende 4 Lernende
Sprache English
Stufe Universität
Erstellt / Aktualisiert 04.02.2022 / 07.02.2022
Lizenzierung Keine Angabe
Weblink
Einbinden
0 Exakte Antworten 89 Text Antworten 46 Multiple Choice Antworten
Fenster schliessen

Differentiate the major characteristics of the standards ISO 9001 and ISO 13485.

ISO 9001:2015                                                        
> Stand-alone standard
> General requirements for a QM system
> Generically applicable   
> Risk based thinking for planning and realization of processes of the QM system

ISO 13485:2016
> Stand-alone standard, but based on ISO 9001 regarding general QM criteria
> Specific requirements of the QM systems for medical devices sector
> Only applicable in the sector of medical devices
> Application of risk management for the safety and performance of medical devices and with regard to the fulfillment of    regulatory requirements

Fenster schliessen

Summarize major content of documentation as needed for EN ISO 13485

- Document controls

- Quality policy & manuals

- Standard operating procedures

- Work instructions

- Forms

Fenster schliessen
Lizenzierung: Keine Angabe

Differences between S1 and S2?

Lizenzierung: Keine Angabe

See picture

Fenster schliessen

What are GLP PRINCIPLES?

Resources, facilities & equipment

Resources, fatalities & equipment

Rules, guidelines, procedures, protocols

Rules, guidelines, procecution, protocols

Archive

Fenster schliessen

What are GLP PRINCIPLES?

Performance of study, study plan, conduct of study, final report

Performance of study, seat plan, conduct of study, final report

Computerized Systems

Computer-based System

Quality assurance, advice, audit, inspection, training

Fenster schliessen

What are GLP PRINCIPLES?

Characterization test article, identification, quality test system, reference item

Characterization test article, identification, quantity test system, referral item

Documentation, SOP, raw data, final report, software, archives, retention of materials

Documentation, SOP, processed data, final report, software, archives, referral of materials

Personnel, qualified, special training, good scientific practice

Fenster schliessen

Name three Good Practice QMS and order them in occurrence in a project.

1. Good laboratory practice (GLP) for early stages of drug development
2. Pre-clinical studies
3. Good manufacturing practice (GMP) for the manufacturing of clinicla product throughout the drug production
4. Good clinical practice (GCP) for/during the clinical studies/trials