Does anyone have procedure on "Regulatory Compliance"?

[mihzago]

Re: Does anyone have procedure on "Regulatory Compliance" ?

so far looks like lots of philosophy but not much help.

the procedure should probably cover things like pre-market application process (e.g. 510(k), MDL, CE marking), establishment registration, medical device reporting vigilance activities, corrections and removals, labeling (not packaging process but rather content and control), clinical trials. Some of these may already be covered under different procedures. There is no requirements to describe these activities in any particular procedure.

Most of these activities are not specifically required by the FDA, but are required by Health Canada (for example procedure(s) describing the medical device license application process, distribution records, labeling, adverse event reporting).

the level of detail will depend on the size and competence of your regulatory group, and risk/complexity of you products; but should describe what type of documentation/forms are required, when various tasks should happen and who is responsible.
in many cases you can copy and paste the requirements straight from the regulation, which in most cases are very descriptive what needs to be done.

 

[SGquality]

Re: Does anyone have procedure on "Regulatory Compliance" ?

SGquality,

If your process-based management system already is in place and working effectively it should include a process for "Deploying Legal Requirements" to the documented parts of your organizational management system.

The documented procedure governing this process identifies the agencies and the people responsible for monitoring changes to legal requirements. The procedure would then show what is done to deploy legal requirements and changes to legal requirements to the management system. It would include evaluating compliance and monitoring effectiveness of this process and procedure.

Of course this process would by monitored and corrected or improved as necessary before it is audited for effectivess.

When employees are trained and supervised to use and improve their management system, the organization is assured of compliance with legal requirements (laws and regulations). Indeed, this is the objective of this process and its procedure.

Your global organizational management may currently be a collection of subsystems operating at a national level. In which case corporate could establish a global policy that mandates development, use and improvement of such processes at the national level but imposing a global procedure would not work too well in my opinion.

John

Great points John. You have brought it rightly and hit the nail on the head . Emnglish, being my second language, was not able to convey my thoughts but its exactly that you have mentioned.

The intent of the procedure is to define and assure compliance to regulatory requirements. In fact, I liked the title of the procvedure to be "Deploying Legal Requirements". Thanks !

What is the objective of this " high level procedure on ?Regulatory Compliance on Medical Devices?"?

Marcelo, we have plants across in different continents amd each of the plant is responsible for their own ISO 13485 certification with any other regional certifications with only FDA Establishment Registration managed centrally. I would like to have this procedure that would put all our regulatory information in a single place.

so far looks like lots of philosophy but not much help.

the procedure should probably cover things like pre-market application process (e.g. 510(k), MDL, CE marking), establishment registration, medical device reporting vigilance activities, corrections and removals, labeling (not packaging process but rather content and control), clinical trials. Some of these may already be covered under different procedures. There is no requirements to describe these activities in any particular procedure.

Most of these activities are not specifically required by the FDA, but are required by Health Canada (for example procedure(s) describing the medical device license application process, distribution records, labeling, adverse event reporting).

the level of detail will depend on the size and competence of your regulatory group, and risk/complexity of you products; but should describe what type of documentation/forms are required, when various tasks should happen and who is responsible.
in many cases you can copy and paste the requirements straight from the regulation, which in most cases are very descriptive what needs to be done.

mihzago, yes, that would be in the procedure. Thanks.

 

[John Broomfield]

Re: Does anyone have procedure on "Regulatory Compliance" ?

Great points John. You have brought it rightly and hit the nail on the head . Emnglish, being my second language, was not able to convey my thoughts but its exactly that you have mentioned.

The intent of the procedure is to define and assure compliance to regulatory requirements. In fact, I liked the title of the procvedure to be "Deploying Legal Requirements". Thanks !

SGQuality,

You are welcome! I'm glad my "philosophy" was helpful to you.

John

 

[kgott]

Re: Does anyone have procedure on "Regulatory Compliance" ?

Hi,

IMO the above can serve as a policy, but hardly as a procedure. The difference is that a (good) procedure is normally detailed and specific, provides useful and concrete instructions and allows objective auditing to.

The above might sound OK for the general industry, but from a heavily regulated industry (like medical devices) perspective it is quite far from being useful or acceptable. I'm sure any auditor would deem it as lacking basic detail - it looks almost like a template waiting to be filled.

Just my humble opinion.

Cheers,
Ronen.

In my opinion:
a procedure describes how the process flows or how the work gets done.
a work instruction defines how to do those parts of the process that are complex or where different results could be the outcome when the task is carried out by different people.

My experience has taught me that people will not read more than three pages before they will ditch it and just ask someone.

I don't believe your suggesting this should be the case but when a procedure runs into a book, it should be broken down into smaller sized documents whether they be called procedures, work instructions or whatever.

All to often I have run into 4+ page procedures and I just go ....

 

[Ronen E]

Re: Does anyone have procedure on "Regulatory Compliance" ?

In my opinion:
a procedure describes how the process flows or how the work gets done.
a work instruction defines how to do those parts of the process that are complex or where different results could be the outcome when the task is carried out by different people.

My experience has taught me that people will not read more than three pages before they will ditch it and just ask someone.

I don't believe your suggesting this should be the case but when a procedure runs into a book, it should be broken down into smaller sized documents whether they be called procedures, work instructions or whatever.

All to often I have run into 4+ page procedures and I just go ....

Hi,

Maybe getting a little

My post said nothing about length. My experience includes preparing many procedures* that were detailed and specific, yet 3 pages or less (actually, I strive at 1-2 pages, but that's a challenge sometimes). As you wrote, if the process is complicated or long, it can also be broken up into several sub-procedures.

*) I don't normally make a distinction between procedures and work instructions, though I accept its legitimacy. To me it's just a terminology distinction with little added value. Usually, both types of documents do the same thing: provide detailed instructions on how to achieve a certain goal. The level of detail depends on the specifics and circumstances, not on the name.

News flash: those who will turn to others and ask instead of trying to understand and follow the written procedure, will usually do so even if it's 1-2 pages long. It's a matter of attitude, not length, though I agree that above a certain number it takes a lot of attitude (for anyone) to stick to the written procedure... but I believe that's more like 7-8 pages with no pictures...

I also think it's more about how the procedure is written than about absolute length. I've seen very badly written procedures that were not that long. Of course they weren't being utilized. People get frustrated when the instructions are ambiguous or the process flow is vague. A procedure should start with very clear statements in sentence #1, then flow extra-clearly from there. Anything which is not that is a waste of paper and time. People shouldn't be searching the document to find where the (applicable) trail starts or ponder what parts are applicable to them in their particular situation. A procedure should be an instrument, not a reading club material.

Procedures that are written for the sole purpose of "being there" end up being just that.

Cheers,
Ronen.

 

[Ajit Basrur]

Re: Does anyone have procedure on "Regulatory Compliance" ?

Great points John. You have brought it rightly and hit the nail on the head . Emnglish, being my second language, was not able to convey my thoughts but its exactly that you have mentioned.

The intent of the procedure is to define and assure compliance to regulatory requirements. In fact, I liked the title of the procvedure to be "Deploying Legal Requirements". Thanks !

I have a simple procedure that just lists all the regulatory commitments for my organization namely -

1. FDA Establishment Registrations - details Owner/Operator details and mentions all establishments with their Registration and FEI number

2. Status of ISO 13485 certifications for all plants

3. Device Listings

4. Drug Master Files - lists all Active DMFs

5. All applicable regulations

6. Refernces to other applicable procedures

 

[funkgirl]

Re: Does anyone have procedure on "Regulatory Compliance" ?

Awesome thread - totally fits into my question if 13485 "regulatory requirements" include device registration. My previous company had procedures documenting the painfully granular details of product registration for each country, which required constant revision. At my current company, I'd like to keep this a bit more high level - scoping the countries where we are/plan to go in the next 2-5 years, with reference to the RA requirements for each country so I don't have to revise my SOP when any little detail for a particular country changes. Any thoughts on that strategy?

 

[funkgirl]

Re: Does anyone have procedure on "Regulatory Compliance" ?

Care to share a copy?

 

[Ronen E]

Re: Does anyone have procedure on "Regulatory Compliance" ?

Awesome thread - totally fits into my question if 13485 "regulatory requirements" include device registration. My previous company had procedures documenting the painfully granular details of product registration for each country, which required constant revision. At my current company, I'd like to keep this a bit more high level - scoping the countries where we are/plan to go in the next 2-5 years, with reference to the RA requirements for each country so I don't have to revise my SOP when any little detail for a particular country changes. Any thoughts on that strategy?

Sounds good to me.