The purpose of this Work Instruction is to describe how to identify, document, validate or where appropriate verify, review, and approve manufacturing, design, labelling changes and temporary changes prior to their implementation.
What is TP20050
Customers experience artifacts/debris and increased background staining on slides during IHC staining Debris is also observed on the lids.
What is CAPA00947-PATH
Parco
Who is Signe's dog
This 1994 song by Mariah Carey is considered the ultimate modern Christmas anthem
What is All I Want for Christmas Is You?
In this country, children leave shoes out for gifts instead of stockings.
What is The Netherlands?
This procedure describes the stability testing required for in vitro diagnostic reagents. Stability test results are used to establish shelf-life under specified storage conditions, transport stability and in-use stability.
What is TP20090
During the EQA performaned by NordiQC in the general Module assessment run B32, B34, and B36 our customers received poor results for a specific and well-known kit
What is CAPA01276
Aura
Who is Maria's dog
Wham!’s 1984 hit about heartbreak during the holidays.
What is Last Christmas?
In this country, people dance around the Christmas tree and sing carols on Christmas Eve.
What is Denmark?
Safety of our IVD products, meaning that all risks have been appropriately reduced through risk control measures and that the benefits of the product outweigh any residual risks.
What is TP20060
The problem identified is that the validated protocols for 2 products does not comply with the intended use according to results received from NordiQC. Medical Affairs has concluded that this could negatively impact patient diagnosis
What are CAPA01170 and CAPA01844
Viggo
Who is Mette's dog
Ariana Grande’s 2014 bop asking Santa for clarity in love.
What is Santa Tell Me?
In this country, people hide brooms on Christmas Eve to keep witches away.
What is Norway?
The purpose of this Work Instruction is to provide guidance for content and sources to the Instructions for Use (IFU) to ensure compliance with applicable regulations and maximum uniformity in the design of the documents.
What is TP 31474
During the R&D Laboratory audit walk-through, several uncontrolled work instructions, without reference to procedure or version control were on display in several places in the R&D laboratory.
What is CAPA01552
Mickey, Zar, Ares and Lasy
Who are Claudias cat and dogs
Justin Bieber’s 2011 hit about kissing under festive greenery.
What is Mistletoe?
In this country, people bake a sweet bread called “Christopsomo” as part of their Christmas tradition.
What is Greece?
The purpose of this Work Instruction is to describe the process, requirements and responsibilities for planning, conducting, assessing, reporting and updating the performance evaluation of in vitro diagnostic (IVD) medical devices manufactured for the European market to ensure compliance with the IVD Regulation 2017/746.
What is TP31950
Frequent >1+ nuclear staining and background with multiple lots of CDx kits for multiple indications during studies
What is CAPA00833-PATH
Ollie and Nellie
Who are Mikkel's rabbits?
Katy Perry’s cozy 2018 track about skipping diamonds for togetherness.
What is Cozy Little Christmas?
In this country, a “Christmas pickle” ornament is hidden in the tree.
What is Germany?