FDA Inspection Do and Don't List
ฝัง
- เผยแพร่เมื่อ 12 มิ.ย. 2024
- If you have a FDA Inspection scheduled, you should prepare your staff. This video will show you what to do and what not to do during your FDA Inspection. If you need additional help or guidance, contact Compliance Insight.
Troy Fugate is the VP and Co-founder of Compliance Insight (www.compliance-insight.com)
Compliance Insight is a leading FDA regulatory and quality assurance consulting firm that offers a range of services to assist companies in navigating the complexities of FDA regulations. With their in-depth knowledge and expertise, Compliance Insight provides invaluable guidance and support to ensure compliance with FDA requirements.
One of their key services is assisting companies with the 510(k) process. They understand the intricacies involved in preparing and submitting 510(k) applications for medical devices. Compliance Insight helps clients gather the necessary data, conduct thorough reviews, and ensure the application meets all regulatory standards, streamlining the path to FDA clearance.
In addition, Compliance Insight has extensive experience in the emerging field of cell and gene therapies. They offer specialized guidance on navigating the unique regulatory landscape for these innovative therapies, helping clients understand and meet FDA requirements to bring their life-changing treatments to market.
Another area of expertise for Compliance Insight is providing assistance with 483 and Warning Letter response and remediation. In the event of an FDA inspection resulting in observations or deficiencies (captured in Form 483), Compliance Insight supports companies in developing comprehensive and effective responses. Their team works closely with clients to address each observation, develop appropriate corrective actions, and ensure timely and compliant resolution.
Whether it's navigating the 510(k) process, advancing cell and gene therapies, addressing 483 observations, or more; Compliance Insight's services encompass comprehensive regulatory support to help companies achieve and maintain FDA compliance, fostering successful product development and market approval.
For more, visit us at www.compliance-insight.com - แนวปฏิบัติและการใช้ชีวิต
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.
love it
I'm sorry, but the cartoon guy at 1:15 looks like Peter Sellers lol
Yeah...it's a crazy world....never again....
Respected sir please provide Information about FDA ammendment act
My last company I had no choice..I was ordered by my manager to be SME for EVERYTHING....hahahaha
I was DEFENSIVE...and I LOVED It....best memory of my life....sometimes you gotta do it...hahaha
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.