Can anyone suggest the name of a person or company that is an "Expert" in Pharma FMEAs?

Are you looking for a contractor?

If you are looking for advice,many here should be able to help.
What are your questions?

Hi,

I have worked in many multinational Pharma companies but we never prepared any FMEAs ? Which type of FMEA are you looking for ? If its Process FMEA, pls let us know the type of process viz. Tablet Mfg., Sterile manufacturing, Liq Orals etc.

If the trend is changing, its good :)

If you want a consultant:

http://www.valqualintl.com/dr-shib-mookherjea.shtml
http://www.valqualintl.com/services.shtml

I worked with Dr. Shib several years ago when I hired his company to help us develop a validation program for drug packaging. Really nice guy and really knows his stuff.

The president of my company killed the program before I finished, unfortunatelty, but this guy is good.

I'm guess I am looking for a contractor. I have not been able to find someone with the academic knowledge along with the practicle experience of performing actual FMEA in the industry. I have seen a number of poor quality pharma / medical device FMEA.

TAC drop me an PM if you are still looking. I have a very extensive network of experts I work with who have practical experience in FMEA. I usually take the lead and bring them in after we do a requirements and gap analysis. Where are you located?