Home - RAPS Regulatory Exchange

See what's new in the Regulatory Open Forum

RE: Stability and Shelf-life using accelerated - FDA ICH or Arrhenius?

Posted by: Lee Leichter, 30 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi Anon, ICH is for medicinal products, not medical devices. FDA has accepted accelerated aging for both packaging (package integrity) and functional testing at the time of submission. The recognized read more
RE: Fostering a Culture of Quality

Posted by: Nathan Blazei, 39 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

Ensure that the leadership team has someone with a strong voice for quality excellence in its ranks. That person leads the charge in demonstrating the importance of a quality culture and building quality read more
RE: Best practices and possible outcomes for FDA inspections

Posted by: Mark Schenk, 3 hours 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, 16 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, 19 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

View this profile on Instagram

RAPS (@regulatoryprofessionals) • Instagram photos and videos

Unanswered posts

Authenticity Issues Found in Clinical Trial Audit

By: Grace Fu , 16 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 , yesterday

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 , yesterday

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 ...
21 CFR reference on compendial method replacements

By: Anonymous Member , yesterday

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 ...
Bill 96 and Quebec's language law

By: Lucy Robertshaw , yesterday

Posted in: Regulatory Open Forum

Hi, We have been made aware of the Bill 96 and Quebec's language law, we sell class 1 medical devices in North America and we are just wondering if anyone can give me some advice on what documents need to be in French? Many thanks Lucy ------------------------------ ...