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RE: Best practices and possible outcomes for FDA inspections

Posted by: Mark Schenk, 27 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

Anon, You might want to have a consultant do a gap analysis of your system (on sight or remote) to help you see the specific gaps in your system and training of your personnel. Most of my work has read more
Authenticity Issues Found in Clinical Trial Audit

Posted by: Grace Fu, 13 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

NMPA is paying more and more attention to clinical trial authenticity audit in IVD as well. Just want to share critical guidelines so that you are aware of what to follow and how to stay compliant for read more
RE: Sample Size for Verification and Validation Tests

Posted by: Vineet Sarin, 16 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi, I came across your post (from one year ago) while searching the forum today. The following webinar contains very helpful information on the topic you asked about: https://www.fdanews.com/media/videos/play/342-sample-size-considerations-for-verification-and-validation read more
RE: FDA 30 Day Notice

Posted by: Cindy Lombardy, 17 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Jeffery, I was hoping for Annual Report based on the below guidance. What did you end up doing? Cindy Guidance for Industry CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports, read more
RE: Derivation of product requirements from regulatory information/standards - Best practice?

Posted by: Anne LeBlanc, 18 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Best practice includes early communication and negotiation about requirements at a high level. First the Marketing function may say where are the target markets and the Design function may suggest the read more

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Unanswered posts

Authenticity Issues Found in Clinical Trial Audit

By: Grace Fu , 13 hours ago

Posted in: Regulatory Open Forum

NMPA is paying more and more attention to clinical trial authenticity audit in IVD as well. Just want to share critical guidelines so that you are aware of what to follow and how to stay compliant for your valuable clinical trial results and efforts. ...
ICH Q2(R2)/M14 expectations

By: Anonymous Member , 23 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Dear all, Q2(R2) states that "Accuracy should be reported as the mean percent recovery of a known added amount of analyte in the sample or as the difference between the mean and the ...
China registration testing samples

By: Anonymous Member , 23 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Per China "Specification for Procedures and Technical Requirements of Drug Registration Testing (Trial Version)": The samples for registration testing should be manufactured on a commercial ...
Fostering a Culture of Quality

By: Anonymous Member , 23 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hoping for some input from this community re: initiatives that have been effective at fostering a culture of quality within your organizations. Thank you!
21 CFR reference on compendial method replacements

By: Anonymous Member , 23 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous I remember reading a 21 CFR regulation stating that if a sponsor plans to use a non-compendial method when a compendial method is available, a head-to-head comparison should be included ...