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Hear from RAPS Power of One participants about the program's benefits

Posted by: Brooke Keith, 2 minutes ago

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Found in: Regulatory Open Forum Discussions

The RAPS Power of One - 90-Day Member Recruitment Challenge is in full swing. It's our annual recruitment challenge, where RAPS members recruit friends and colleagues to join our society as members.  read more
RE: IND Module 3 versioning?

Posted by: Tom Stothoff, 13 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

I'm not aware of there being a requirement to have a date/version on CTD documents, but I highly recommend adding at least a date to header or footer of each document. To me just a date is suffice. I've read more
RE: QMSR and 21CFR Chapter I Subchapter H

Posted by: Christoph Kiesselbach, 23 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi Katie, as far as I can see QMSR (Quality Management System Regulation) is just the future title of the changed 21 CFR Part 820 that is a part of Subchapter H (which includes Parts 800-898). The title read more
RE: QMSR and 21CFR Chapter I Subchapter H

Posted by: Kevin Randall, 24 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

Short answer: Yes absolutely except for the QMSR's revisions of Subchapter H Part 820. In other words, the QMSR doesn't change Subchapter H's basic requirements such as those for contact lens solutions, read more
QMSR and 21CFR Chapter I Subchapter H

Posted by: Katherine Pyles, 47 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello. With the new QMSR regulations is 21CFR Chapter I Subchapter H still required? Or does QMSR replace those requirements/regulations? ------------------------------ Katie Pyles ----------------- read more

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Hear from RAPS Power of One participants about the ...

By: Brooke Keith , 2 minutes ago

Posted in: Regulatory Open Forum

The RAPS Power of One - 90-Day Member Recruitment Challenge is in full swing. It's our annual recruitment challenge , where RAPS members recruit friends and colleagues to join our society as members.   We thought it might be ...
Location of completed eCTD sequence folders - network ...

By: Katelyn Mulligan , an hour ago

Posted in: Regulatory Open Forum

Hi there, I wanted to ask if anyone has experience with successfully maintaining the eCTD folder structure for completed sequences on a SharePoint site. This is unfamiliar to me, and I am used to seeing it maintained in a network/local drive location. ...
Module 1 Content for 351(a) BLA

By: Anonymous Member , an hour ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Dear Colleagues, Do the following eCTD sections apply for a 351(a) BLA?: 1.3.2 Field Copy Certification 1.3.5.3 Exclusivity Claim Thank you for your guidance!
Do we need to give a dealer proprietary formula in ...

By: YEMI IJOSE , 21 hours ago

Posted in: Regulatory Open Forum

Yemi Ijose Regulatory Affairs Senior Manager GC America Inc. ...
Unofficial Medical Device Study Group

By: Karen Underwood , 23 hours ago

Posted in: Regulatory Open Forum

Hi Everyone Just a reminder we will meet this week at 3 pm to 4 pm on Friday. I will present Chapter 8 of EU, from the 5th edition of the RAPS Study Guide. Join Zoom Meeting https://umaryland.zoom.us/j/96213811970?pwd=V2lQeWowQTAxaDc2U2lpU0h3dVZ4dz09 ...