As some e that works in the industry this was really helpful. No matter how many inspections I go through, it’s always nerve wracking - not only bc of the inspection- in addition being worried about performing. Well in front of your superiors.
Good presentation. Just a few points: The presentation uses the word, "investigator" but in the presentation you also use the word inspector. I work in pharma and we will never see an inspector at our site. There's a difference. Also, it mentions FDA won't look at "Management Reviews". Not true and actually, a requirement of 211.180(f). Management Reviews/Quality Councils are the methods used to keep senior official apprised as to the status of the QMS and what issues there are and if resources are needed. Reference the PreAmble on this as the FDA Commissioner speaks to this point. Also, a 483 is not necessarily a list of significant findings. It's what the investigator "believes" to be a GMP violation. It doesn't make it so. Also, firms aren't required by law to respond to a 483 however, I've never heard of a company that doesn't. None of this should take away from the fact that this is an excellent presentation! Also, as far as "Don'ts", I always include that folks should never sign anything (affidavit, form 463a).
As some e that works in the industry this was really helpful. No matter how many inspections I go through, it’s always nerve wracking - not only bc of the inspection- in addition being worried about performing. Well in front of your superiors.
Good presentation. Just a few points: The presentation uses the word, "investigator" but in the presentation you also use the word inspector. I work in pharma and we will never see an inspector at our site. There's a difference. Also, it mentions FDA won't look at "Management Reviews". Not true and actually, a requirement of 211.180(f). Management Reviews/Quality Councils are the methods used to keep senior official apprised as to the status of the QMS and what issues there are and if resources are needed. Reference the PreAmble on this as the FDA Commissioner speaks to this point. Also, a 483 is not necessarily a list of significant findings. It's what the investigator "believes" to be a GMP violation. It doesn't make it so. Also, firms aren't required by law to respond to a 483 however, I've never heard of a company that doesn't. None of this should take away from the fact that this is an excellent presentation! Also, as far as "Don'ts", I always include that folks should never sign anything (affidavit, form 463a).
I'm sorry, but the cartoon guy at 1:15 looks like Peter Sellers lol
Respected sir please provide Information about FDA ammendment act
I was DEFENSIVE...and I LOVED It....best memory of my life....sometimes you gotta do it...hahaha
Yeah...it's a crazy world....never again....
My last company I had no choice..I was ordered by my manager to be SME for EVERYTHING....hahahaha
love it
I think this is bullshit this is America and we should be able to ask question
I'm not sure what you are meaning but you can always ask a question of an inspector.