Lean application in Regulatory Affairs

[evilchilli_420]

Hello everyone,

I wanted to inquire if anyone has experience in implementing Lean in Regulatory Affairs projects i.e. submissions and/or other projects. Can you please provide a brief overview of your experience in those projects?

Thanks in advance.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!

 

[AnaMariaVR2]

Hi
I do not have experience in implementing Lean in Regulatory Affairs projects i.e. submissions...but your question is an interesting proposition in this field.

I would also be curious to see how "LEAN" can we get in RA as the regulatory environment is constantly changing & compliance requirements can be very complicated. It depends also on the size of the company & their regulatory framework. Lean in RA is more challenging as our "specs" may vary, or negotiated during the course of a filing...it depends of the situation/case.

Basically, I would start by making sure these below are evaluated & included in some degree (i.e., for compliance, to reduce waste/redundancies, assess/manage risk, etc.):

- essential processes have been defined w/ process maps/owners;
- essential SOPs, policies, forms & corporate guidelines;
- train staff on these, fine tune, optimize & readjust;
- analyze patterns, learn & integrate-get rid of noise;
- simplify compliance​

It is easier said that done...but these are my 2 cents

I'll be happy to hear more about this topic as it also interest me.


Find below some interesting resources on the topic or related:

What Is Lean Compliance?
http://healthcare-executive-insight.advanceweb.com/Features/Articles/What-Is-Lean-Compliance.aspx

Lean Compliance
http://www.compliancezen.com/compliance_zen/lean-compliance/

[thesis] THE APPLICATION OF LEAN THINKING TO PHARMACEUTICAL QUALITY SYSTEMS, DEFINING THE FDA AS THE CUSTOMER
http://jclauson.com/msqa/sample_thesis_fall_04.pdf

Lean Compliance for Mid-Size Companies
http://www.ceruleanllc.com/wp-content/articles/Lean_Compliance_JGXP2008_CERULEAN.pdf

38 Point Compliance Self-Assessment
http://www.ceruleanllc.com/wp-content/checklists/38-Point_Lean_Compliance_Self-Assessment_CERULEAN.pdf​

 

[somashekar]

Hello everyone,

I wanted to inquire if anyone has experience in implementing Lean in Regulatory Affairs projects i.e. submissions and/or other projects. Can you please provide a brief overview of your experience in those projects?

Thanks in advance.

If regulatory requirements permit you to be lean, then we can implement Lean in Regulatory Affairs projects i.e. submissions and/or other projects to that extent.
So the cue is to get more deeper and correct understanding and interpretation of the regulatory requirements.