Vérifier et valider les méthodes analytiques
saurez vous accomplir votre mission?
Start
Mission 3
Mission 2
Mission 1
La cible
Mission 6
Mission 5
Mission 4
Mission 1 La cible
Question 1/4
Mission 1 La cible
Question 2/4
Mission 1 La cible
Question 2/4
Le choix de la portée : a ou B ?
La portée A concerne les méthodes reconnues et validées par le fabricant (IVD-IVDR) avec marquage CE ainsi que les méthodes faisant l'objet de normes, d’instructions issus de consensus international ou de règlementation, de publications internationales validées. La validation des méthodes est réduite à une « vérification » sur site qui aura pour objectif de montrer que des performances fabricant sont atteintes dans les conditions de travail du laboratoire (conditions ambiantes, personnel, équipements, etc.). La portée B concerne les méthodes développées ou adaptées par le laboratoire, nécessitant une validation approfondie. En portée B, une « validation » de la méthode adaptée ou développée sera nécessaire. Dans ce cas, le laboratoire établit l’ensemble des critères de la qualité de la méthode afin d’en démontrer la maîtrise.
Mission 1 La cible
Question 3/4
MODIFICATION de méthode fournisseur : assouplissement du SH REF 08 V6
En cas de modification des recommandations fournisseurs non liées à l'étape de mesure elle-même (relatives à une matrice échantillon, un matériel annexe ( incubateur, produits chimiques ...) , un consommable tel qu'un support de prélèvement, un prétraitement...), un maintien de la méthode en portée A peut malgrè tout être toléré. Dans ce cas malgré tout le laboratoire doit pouvoir démontrer que les modifications sont justifiées, validées et sans impact sur l'étape de mesure.
Mission 3
Mission 2
Mission 1
La cible
Le terrain
Mission 6
Mission 5
Mission 4
Etudier le terrain : L'analyse bibliographique
Préambule
Avant de commencer une validation/vérification de méthode, vous devez étudier a minima certains éléments bibliographiques : - documentation fournisseur
- ne pas hésiter à demander des précisions, communications orales ou affichées, études ... au fournisseur
- littérature scientifique
- ne pas toujours se contenter des références indiquées par le fournisseur
- indispensable en portée B
- recommandations des sociétés savantes en vigueur, textes réglementaires ....
- connaitre les perforMances attendues de la méthode
- connaitre les limites d'acceptabilité
- definir les criteres de performance
Mission 2 Etudier le terrain
Mission 3
Mission 2
Mission 1
Le terrain
La cible
Les risques
Mission 6
Mission 5
Mission 4
Mission 2 Here you can put an important title
Question 2/3
Mission 5 Here you can put an important title
Drag concepts to the corresponding group 2/2
Group 2
Group 1
Interactivity
Animation
Creativity
WOW Effect
Magic
Solution
Continue
Mission 3
Mission 2
Mission 1
Le terrain
La cible
Les risques
Mission 6
Mission 5
Mission 4
Les performances
Mission 3 Here you can put an important title
Mission 3 Here you can put an important title
Complete all missions to get your certificate
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Provide context for your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 4 Here you can put an important title
Question 1/4
Mission 4 Here you can put an important title
Question 2/4
Mission 4 Here you can put an important title
Question 3/4
Mission 4 Here you can put an important title
Question 4/4
Complete all missions to get your certificate
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Provide context to your topic with a subtitle
Contextualize your topic with a subtitle
Provide context for your topic with a subtitle
Mission 5 Here you can put an important title
Drag concepts to the corresponding group 1/2
Group 2
Group 1
Interactivity
Animation
Creativity
Wow effect
Magic
Solution
Continue
Mission 5 Here you can put an important title
Drag concepts to the corresponding group 2/2
Group 2
Group 1
Interactivity
Animation
Creativity
WOW Effect
Magic
Solution
Continue
Complete all missions to get your certificate
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6 Aquí puedes poner un título destacado
Question 1/3
Mission 6 Aquí puedes poner un título destacado
Question 2/3
Mission 6 Here you can put a highlighted title
Question 3/3
Congratulations! You have completed all the missions
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Certificate
AWESOME CERTIFICATE
Top employee
Here you can put a standout title, something that captivates your audience
Are you sure you want to exit?
Exit
Back
Creativity
Interactivity
WOW Effect
Animation
Magic
Got an idea?
Let the communication flow!
With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.
- Generate experiences with your content.
- It’s got the Wow effect. Very Wow.
- Make sure your audience remembers the message.
Creativity
Interactivity
Wow Effect
Animation
Magic
Got an idea?
Let the communication flow!
With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.
- Generate experiences with your content.
- It’s got the Wow effect. Very Wow.
- Make sure your audience remembers the message.
Creativity
Interactivity
Wow Effect
Animation
Magic
Got an idea?
Let the communication flow!
With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.
- Generate experiences with your content.
- It’s got the Wow effect. Very Wow.
- Make sure your audience remembers the message.
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Transcript
Vérifier et valider les méthodes analytiques
saurez vous accomplir votre mission?
Start
Mission 3
Mission 2
Mission 1
La cible
Mission 6
Mission 5
Mission 4
Mission 1 La cible
Question 1/4
Mission 1 La cible
Question 2/4
Mission 1 La cible
Question 2/4
Le choix de la portée : a ou B ?
La portée A concerne les méthodes reconnues et validées par le fabricant (IVD-IVDR) avec marquage CE ainsi que les méthodes faisant l'objet de normes, d’instructions issus de consensus international ou de règlementation, de publications internationales validées. La validation des méthodes est réduite à une « vérification » sur site qui aura pour objectif de montrer que des performances fabricant sont atteintes dans les conditions de travail du laboratoire (conditions ambiantes, personnel, équipements, etc.). La portée B concerne les méthodes développées ou adaptées par le laboratoire, nécessitant une validation approfondie. En portée B, une « validation » de la méthode adaptée ou développée sera nécessaire. Dans ce cas, le laboratoire établit l’ensemble des critères de la qualité de la méthode afin d’en démontrer la maîtrise.
Mission 1 La cible
Question 3/4
MODIFICATION de méthode fournisseur : assouplissement du SH REF 08 V6
En cas de modification des recommandations fournisseurs non liées à l'étape de mesure elle-même (relatives à une matrice échantillon, un matériel annexe ( incubateur, produits chimiques ...) , un consommable tel qu'un support de prélèvement, un prétraitement...), un maintien de la méthode en portée A peut malgrè tout être toléré. Dans ce cas malgré tout le laboratoire doit pouvoir démontrer que les modifications sont justifiées, validées et sans impact sur l'étape de mesure.
Mission 3
Mission 2
Mission 1
La cible
Le terrain
Mission 6
Mission 5
Mission 4
Etudier le terrain : L'analyse bibliographique
Préambule
Avant de commencer une validation/vérification de méthode, vous devez étudier a minima certains éléments bibliographiques :- documentation fournisseur
- ne pas hésiter à demander des précisions, communications orales ou affichées, études ... au fournisseur
- littérature scientifique
- ne pas toujours se contenter des références indiquées par le fournisseur
- indispensable en portée B
- recommandations des sociétés savantes en vigueur, textes réglementaires ....
Mission 2 Etudier le terrain
Mission 3
Mission 2
Mission 1
Le terrain
La cible
Les risques
Mission 6
Mission 5
Mission 4
Mission 2 Here you can put an important title
Question 2/3
Mission 5 Here you can put an important title
Drag concepts to the corresponding group 2/2
Group 2
Group 1
Interactivity
Animation
Creativity
WOW Effect
Magic
Solution
Continue
Mission 3
Mission 2
Mission 1
Le terrain
La cible
Les risques
Mission 6
Mission 5
Mission 4
Les performances
Mission 3 Here you can put an important title
Mission 3 Here you can put an important title
Complete all missions to get your certificate
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Provide context for your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 4 Here you can put an important title
Question 1/4
Mission 4 Here you can put an important title
Question 2/4
Mission 4 Here you can put an important title
Question 3/4
Mission 4 Here you can put an important title
Question 4/4
Complete all missions to get your certificate
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Provide context to your topic with a subtitle
Contextualize your topic with a subtitle
Provide context for your topic with a subtitle
Mission 5 Here you can put an important title
Drag concepts to the corresponding group 1/2
Group 2
Group 1
Interactivity
Animation
Creativity
Wow effect
Magic
Solution
Continue
Mission 5 Here you can put an important title
Drag concepts to the corresponding group 2/2
Group 2
Group 1
Interactivity
Animation
Creativity
WOW Effect
Magic
Solution
Continue
Complete all missions to get your certificate
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6 Aquí puedes poner un título destacado
Question 1/3
Mission 6 Aquí puedes poner un título destacado
Question 2/3
Mission 6 Here you can put a highlighted title
Question 3/3
Congratulations! You have completed all the missions
Mission 3
Mission 2
Mission 1
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Mission 6
Mission 5
Mission 4
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Contextualize your topic with a subtitle
Certificate
AWESOME CERTIFICATE
Top employee
Here you can put a standout title, something that captivates your audience
Are you sure you want to exit?
Exit
Back
Creativity
Interactivity
WOW Effect
Animation
Magic
Got an idea?
Let the communication flow!
With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.
Creativity
Interactivity
Wow Effect
Animation
Magic
Got an idea?
Let the communication flow!
With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.
Creativity
Interactivity
Wow Effect
Animation
Magic
Got an idea?
Let the communication flow!
With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like! Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.