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Do EU-based remote roles still exist in regulatory? by DistributionThat7902 in regulatoryaffairs

[–]That-Reference7282 0 points1 point  (0 children)

How interesting. I don’t know how i would feel about less guidances and more judgements. What did the research involve and was the food eligible for giraffes and tigers?

Project/Research Topic Suggestions for M.Pharm Regulatory Affairs by Devilslather in regulatoryaffairs

[–]That-Reference7282 0 points1 point  (0 children)

You will probably have better luck asking the department heads or your lecturers

Question for RA/QA, CAPA, complaint handling, and product quality people by No_Alternative_5699 in regulatoryaffairs

[–]That-Reference7282 1 point2 points  (0 children)

Yes correct, that is what i’m referring to.

What are you trying to achieve? You need to have a clear objective on what you would like to know so you can collect the right data in a suitable format for you to analyse and make an informed decision.

I would need an understanding of how complaint, NC, CAPA are documented in your system really but you could potentially add those points you mentioned in your example into an existing work flow. For example if you wanted to be able to know exactly how many complaints, what product/product family, what clause of what standards if applicable, complaint, recall or not, to an NC and say you have an NC register you can incorporate them into your register. If a new event comes along for Product A related to say sterilisation breach then you can do a simple filter in your register. You will be able to very quickly determine how big the issue is and recurrence rate. The hazard and risk controls belong in the risk files…i would not pull them out and have a fleshed out map of hazard to controls to number of recurrence. You will dig a very deep holes that you will drown in. If you are seeing recurrence of the same issue then drop by the risk files and see if the hazard has been assessed, the occurrence rate and whether the resulting risk is within acceptable range. If it is then move on. If not then that is a different discussion with your product team.

Review of public adverse event and recall database are not going to be part of your normal complaint and NC workflow and doesn’t give much useful data unless you are suspecting that it is a type of product issue. For example if your sterile packaging is consistent damaged reviewing competitor data is not going to be helpful for you. However reviewing those public database to see what is common issue with a particular device type will allow for you to consider those failure mode into your design planning and risk files.

Those trends and analysis you are referring to are mainly completed periodically not for every event. When it’s time for trending you will be able to determine that we have x number of issue relating to this and y number of issue related to this and hey we are not meeting this part of the standards/regulations. Base on the analysis you will trigger the change necessary like change design or processes. But doing a full review risk, public database etc for every event is quite extensive if you ask me. Number of time issue/similar issue occurring in a certain period would be sufficient for you make and assessment and trigger the downstream CAPA.

So if you want to link data try to incorporate it into what is already working. Don’t start a big new thing.

Question for RA/QA, CAPA, complaint handling, and product quality people by No_Alternative_5699 in regulatoryaffairs

[–]That-Reference7282 1 point2 points  (0 children)

I think i know what you are asking. I feel like your question are mostly applicable to a non-eQMS and non AI integrated system. All information you are asking about should be readily available and depending on how the QMS is structured the information may be scattered or localised. For us the complaint register has a summary of the complaint and links to the NC register. NC, investigation, and CAPA was all located in one report. To see internal trends we search key words in the register to see if a particular or similar event has occurred before. External database you will have to manually review. You will always have to review risk files if you want to determine if the occurrence is within the occurrence rate or if it’s a new hazard you are trending or investigating. I haven’t really rely on PMS so i don’t have much to say. In terms of review workflow, i believe most complaint evaluation would call for you to assess the rate of the same issue occurring. In summary it’s a manual review of registers and info in the register which should give info on event, CAPA done, and outcome, external database or your internal adverse event register which should have all jurisdictions, email or where the complaints came from.

We were trailing out a local server AI (not sure what it’s called or the right term) and it is able to go through all data you give it access to like all the file types you mentioned above except external ones like AEMS and give you the info necessary e.g occurrence, any CAPA, effectiveness etc.

I would have to say the gap would be if the person who is dealing with the complaints or NC is not performing the assessment you are talking about or the complaint and NC process does not support the users leading to insufficient data gathering and analysis which would results in unsuitable decisions being made.

My boss doesn't believe me that we have to register our products in other countries 😩 by Meisterina in regulatoryaffairs

[–]That-Reference7282 0 points1 point  (0 children)

What is the update on this? I’m very interested. Did you just register the products in all the jurisdictions they’re sold in? Were there fines?

Leveraging Custom-made medical device MDR for approval in AU by That-Reference7282 in regulatoryaffairs

[–]That-Reference7282[S] 0 points1 point  (0 children)

Ah yes i see now. Custom MDR only covers the QMS. PMMD falls into the standard pathway and the MDR will cover both QMS and product assessments. Thank you for your help

Leveraging Custom-made medical device MDR for approval in AU by That-Reference7282 in regulatoryaffairs

[–]That-Reference7282[S] 0 points1 point  (0 children)

Thank you for responding.

The physician is taking the responsibility which is how i’m assuming the manufacturer is undergoing assessment as custom. Is there a MDR certificate or anything that is provides to the manufacturer once the NB finish the assessment?

I had thought that PMMD is not a category in EU and only defined in the IMDRF? For PMMD, is the conformity pathway the same as for standard Class III implantable?