Your opinions and thoughts – Why do you visit the forum?


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I like @Ed Panek's layout and will add two for further knowledge for @Eric Gasper:
I started to visit to:
learn the real why's to whats, learn to distinguish need to from do because that's what always has been/others do as my first (QA) job in medtech was without much preparation/qualification nor a (respectable) mentor or reference.

I continue to visit to:
learn the real why's to whats, learn to distinguish need to from do because that's what always has been/others do as it's a big big medtech world and much remains to learn or what I learned has changed due to new insights &
to spread the things I've learned by experience, elsewhere or here but rephrased because others will be in a similar position as me and this is the place that counters the consultancy/regulatory documents filled with oh so many circular reasoning or copy-paste behavior (that will be found and peer-reviewed by others, no sense in starting my own blog).

I stay mostly in:
General auditing as well as medtech matters specifically, because that's where I feel my voice genuinely has some authority and I feel capable of making authentic statements.

Though I'd like to, I stay away from:
Standardization & regulation (as an activity with output). I use them, work within and with them and will comment on their contents and application. However I regard the current way they come about, change and the involved organizations (both governmental and non-governmental) as beyond my scope of non-trivial influence now and in the future. I believe that the mere fact that people must engage with their generic existence is more of a boon to the world than the idea that checkmarking every single thing is what is making the work safe. Regulators and management too often believes writing it down and 'communicating' it is what leads to it becoming reality.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
One thing I forgot; there is the law and the implementation of the law. I can read requirements and either oversimplify or overcomplicate them. This forum provides a more "What is really being requested here?" answer. Will this take 4 hours a month to maintain or 40 hours a month to maintain?

Ajit Basrur

Dalai Lama said, "“Share your knowledge. It is a way to achieve immortality.” and that sums up why I visit this forum. In 2005, I was a lurker, got interested and participated in responding to questions and that was a wonderful start of my journey. I was a Pharma and Medical Device quality professional but this forum taught me quality aspects followed in other industries.

Thank you everyone!


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I've always said that regulatory affairs is a 100% experiential profession. I know the certificaters and diploma mills would beg to differ, but I'm still firm on that point.

RA is not about the regulations. You can memorize those chapter and verse. It is also not about meeting requirements. It is about, as Ed Panek puts it, implementation. How exactly do the requirements apply to your device, being made by your company, in its particular circumstances, with its business goals? ("It depends.") You won't find that in the regulations. And how can you implement in a business-savvy way (not to be confused with "shortcuts" or "the minimum we can do.")? How do you manage regulatory-related risk? How do you present your data so that the regulators get it?

I would add to Ed's example, "...and what have people found determines if it takes 4 or 40 hours and what approaches have they found to reduce the number of hours it will take?"

Access to other experienced RA professionals, sans trolls, marketeers, and "inspirational" posts per LinkedIn, that is why I come here.

monoj mon

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I visit this forum almost every single day to learn new things and to discuss the knowledge I believe that I have gained from the real life experiences. I don't think there is any other way to discuss your thoughts/questions with such a huge group of highly experienced people.

Elsmar has become my morning coffee, cannot skip a day without visiting it ;).


Starting to get Involved
I work for a small business, it's really useful having this source of information as I don't have any colleagues with quality management experience outside our company. I started visiting during transition from ISO9001:2008 to 2015 but have only registered recently.
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