What are all the Regulatory Affairs Aspects

paulag

Involved In Discussions
Dear Regulatories,

I have to :magic: create some kind of chart, checklist or SOP to show the impact ofRegulatory Affairs requirements on every other division of the company, like Sales, Quality Management, Research & Development, Project Management...

Does anyone have an idea how I can make sure not to forget anything or anyone? Or provide a link to good literature about it, or even a template?

:thanx:
 

AnaMariaVR2

Trusted Information Resource
Every company or group runs their regulatory operations/affairs in their own particular way for specific reasons, interpretation, experience, routine or hopefully, company policy & most importantly because of compliance. It is extremely challenging to write an SOP for RA due to the nature & chaos of their day-2-day operations, handling, managing, etc. I personally think that an RA SOP might set the group for deviations/non-conformances (failure) as filings, submissions & regulatory support varies between countries. Plus it would be very easy during an inspection to proof the group is out of compliance. RA is different than QA or QC. I would recommend the group to agree on some basic common processes, a toolbox for working & training for the team.
You have to built your own checklist/template based on your needs & based on lessons learned by your team's expertise, & incorporate those into your operating processes.
:2cents:
Good luck! :agree1:
 

paulag

Involved In Discussions
Every company or group runs their regulatory operations/affairs in their own particular way for specific reasons, interpretation, experience, routine or hopefully, company policy & most importantly because of compliance. It is extremely challenging to write an SOP for RA due to the nature & chaos of their day-2-day operations, handling, managing, etc. I personally think that an RA SOP might set the group for deviations/non-conformances (failure) as filings, submissions & regulatory support varies between countries. Plus it would be very easy during an inspection to proof the group is out of compliance. RA is different than QA or QC. I would recommend the group to agree on some basic common processes, a toolbox for working & training for the team.
You have to built your own checklist/template based on your needs & based on lessons learned by your team's expertise, & incorporate those into your operating processes.
:2cents:
Good luck! :agree1:
AnaMaria,
Thanks a lot for your feedback. This is also the way I see it, and I'm still trying to get everyone away from the idea of a general RA SOP. Getting started one step below, with instructions for CE marking and DMFs...
Have a nice weekend!
 

somashekar

Leader
Admin
Dear Regulatories,

I have to :magic: create some kind of chart, checklist or SOP to show the impact ofRegulatory Affairs requirements on every other division of the company, like Sales, Quality Management, Research & Development, Project Management...

Does anyone have an idea how I can make sure not to forget anything or anyone? Or provide a link to good literature about it, or even a template?

:thanx:
What Industry segment are you involved with ?
 

somashekar

Leader
Admin
Medical Device and Packaging Material (injection molding)
I have no idea of your location, however, does your medical device have YOUR LABEL ?
Are they aligned to European union regulations (CE mark, EU AR requirements, EU countries product registration, Periodic MDD assessment) USA (FDA inspection QSIT, 510K) Canada (CMDCAS ISO 13485, Device licence, renewals). similarly the specific requirements applicable to other countries, regions (like Brazil, Japan, Austraila,....)
Are you certified to a QMS like ISO13485 ?
Aspects about all these are a ton of load on regulatory.
When you come more specific, you can get more specific responses.
 

paulag

Involved In Discussions
I have no idea of your location, however, does your medical device have YOUR LABEL ?
Are they aligned to European union regulations (CE mark, EU AR requirements, EU countries product registration, Periodic MDD assessment) USA (FDA inspection QSIT, 510K) Canada (CMDCAS ISO 13485, Device licence, renewals). similarly the specific requirements applicable to other countries, regions (like Brazil, Japan, Austraila,....)
Are you certified to a QMS like ISO13485 ?
Aspects about all these are a ton of load on regulatory.
When you come more specific, you can get more specific responses.
We are located in 3 european countries, are 13485 certified and have few CE marked products of our own (IIa). Most of our business is contract manufacturing, so we at least have to consider US FDA and Japan requirements.

You are perfectly right - the more I write, the clearer it becomes that I can't expect specific answers or help from the distance...

Thank you very much for your feedback. See you soon on a more specific issue, maybe :)
 
S

ssz102

how many law items will be impact your company according to the system certificated requirements, you need to know firstly

these clauses will be involved in what department, need to identify by yourself

in order to meeting these clause, what actions need to be take?

send these requriments to related department and told them how to dealing with? then you minitoring the effective of implement
 

paulag

Involved In Discussions
how many law items will be impact your company according to the system certificated requirements, you need to know firstly

these clauses will be involved in what department, need to identify by yourself

in order to meeting these clause, what actions need to be take?

send these requriments to related department and told them how to dealing with? then you minitoring the effective of implement
You mean that I should train, let's say HR, about provisions of ISO 13485 (6.1, 6.2), 21 CFR 820 (20b, 25a) and MHLW Ordinance 169 (21-23) and then check, maybe by internal audit, if they implemented the requirements?

I was thinking about an SOP, but this approach would also work. Good idea, thanks!
 
S

ssz102

in a way, SOP mentioned here equal to evaluation of complaince, so checklist is the best way of evaluation

meantime, the contents i said is a part of checklist, but need to updated it by youself

BTW, training should be do before the checklist send to related dept
 
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