Marketing Communication Change Control - Identifying best practices

M

merlinpa

#1
I am interested in identifying best practices for control of marketing communication (labeling) in a medical device environment. Labeling associated with the product itself (on the device and its packaging) is one thing that is pretty straight forward. While processes associated with marketing communications is another thing entirely.
  • How is this controlled within your company?
  • Who has primary responsibility?
  • Are there situations where the responsibility may shift between marketing and QA/RA?
  • What are they and how have you managed the shift and stayed in control?
 
Elsmar Forum Sponsor
#2
In our organization we assign to each label a part number and we add it as a product to our document control system, regulatory wise labeling is part of the product.
So answering your 1st and the 2nd bullets – use document control to control it, give approval permit only to the Marketing and to the QA+RA.

There are a lot of situations were the responsibility for the labeling will shift from the marketing into the QA/RA due to new regulations or CAPA ect.

The control of it is under your document control system and the compliance should be monitored by your internal audits.
 
R

Roland Cooke

#3
Just to extend this conversation a bit, there are other forms of marketing communication that you need to keep an eye on.

Company website
Physician training programmes
Tradeshow documentation
Salesforce training documentation

I'm sure there are other things that can be added to this list.

Try to think worst case - e.g. if FDA looked at this "communication tool", would they have an issue?
 
M

merlinpa

#4
Agree with Roland about other forms of Communication Control. These are the ones that are more elusive and examples that I seek best practices information about. Anyone!
 

v9991

Trusted Information Resource
#5
you might find my response relevant to final-product in regulated market scenario and i am not sure about best practices, but let me share the procedure which we implemented ...

1. atleast regulatory is always in-the-loop for design & dev. of promotional materials; it ensures the compliance to relevant regulations.
2.QA/QC is involved if the material is marked for any submission to regulatory agencies or is part of any SKU to be distributed to market! [manufacturing controls!]
3. packaging design & development team is common agency in the all above variants of process.
4. this is apart from the competent teams which participate in the design and dev process of promotional materials [viz., marketing, medical/clinical services, legal etc.,]

there are FDA regulations on this subject matter...here are few quick references
http://www.fda.gov/cder/ddmac/lawsregs.htm
http://www.fda.gov/cder/ddmac/index.htm

obviously, there is regulatory importance associated even with the marketing communication as well...
1. FDA monitors promotional materials distributed over net.
2. this is true for even products for which pre-market approvals are not required! [ where a mere registration is sufficient to market; ];

You have number of such examples cited under warning letters section on fda.gov website, with examples where organisations are pulled up for staking "false-claims" / "un-substantiated-claims" / "claims which are not substantiated by scientific evidence".

hope this helps.
valiveti.
 
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