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Compliance Blog

This blog is a collection of compliance content, Training and Experts views

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Compliance Blog | complianceblog.blogspot.com Reviews

https://complianceblog.blogspot.com

This blog is a collection of compliance content, Training and Experts views

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complianceblog.blogspot.com complianceblog.blogspot.com
1

Compliance Blog: 12/01/2010 - 01/01/2011

http://complianceblog.blogspot.com/2010_12_01_archive.html

Thursday, December 16, 2010. Sponser Meeting with FDA some facts. There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories. Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days). Type B: Procedural meetings – Pre-IND meeting, EOP2, pre-NDA, etc (within 60 days). These meetings are specifically to help prescription drug approvals.

2

Compliance Blog: What are Suspicious Activity Reports and Who Should File ?

http://complianceblog.blogspot.com/2014/05/what-are-suspicious-activity-reports.html

Thursday, May 29, 2014. What are Suspicious Activity Reports and Who Should File? The BSA also requires every US national bank to file a Suspicious Activity Report (SAR) when they detect certain known or suspected violations of federal law or suspicious transactions related to a money laundering activity or a violation of the BSA. A SAR filing is required for any potential crimes:. Involving insider abuse regardless of the dollar amount;. A transfer between accounts;. An exchange of currency;. If there i...

3

Compliance Blog: 05/01/2011 - 06/01/2011

http://complianceblog.blogspot.com/2011_05_01_archive.html

Wednesday, May 25, 2011. What is FMEA and How to Use it. Failure Modes and Effects Analysis is the subject of an international standard, IEC 60812-Analysis techniques for system reliability-Procedure for failure mode and effects analysis (FMEA). Most medical device companies use FMECA, although they incorrectly label it as “FMEA”. The title of the standard, Analysis techniques for system reliability-Procedure for failure modes and effects analysis (FMEA), reflects its correct use. Links to this post.

4

Compliance Blog: Dos and Don't during and after FDA inspections

http://complianceblog.blogspot.com/2009/02/dos-and-dont-during-and-after-fda.html

Tuesday, February 24, 2009. Dos and Don't during and after FDA inspections. This is a collection of facts from different experts and not the whole thing, there might be other dos and don'ts other than these applicable as per particular situation. Have Scribe present at all times during the interview. Leave as soon as interview is over. Listen carefully and repeat the question or ask it to be repeated, if necessary. Answer completely, directly and honestly. Speak slowly and clearly. Inspection co-ordinato...

5

Compliance Blog: Dos and Don'ts of responding to Unsoliciated offlabel requests

http://complianceblog.blogspot.com/2014/06/dos-and-donts-of-responding-to.html

Sunday, June 29, 2014. Dos and Don'ts of responding to Unsoliciated offlabel requests. Be specific, truthful, unbiased and scientific. Keep private response specific to the question. Make sure the persons responding on behalf of you are medical or scientific personnel. Make sure sales and marketing personnel are not involved at all even in training and awareness. Makes sure you are keeping record of all the responses. Q - Is News release about an investigator-lead IND study an off-label promotion? Simply...

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