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  • To add to Dan's point (which is  correct), the company whose name is on the product is responsible for everything in it, regardless of who performs the activity.  So, as Dan points out here,  7.4 Purchasing applies in this situation. A very specific Quality Agreement should delineate the responsibilities for each party.  Additionally, it needs to discuss ...

  • Posted in: Boston Chapter

    Hi all! Thought some of you or your colleagues might be interested in this event! Hope to see you (David!) there! EVENT: American Society for Quality (ASQ) Boston Section's Monthly Meeting   DATE : Monday, November 18, 2019 TIME : 6:00p.m. – 8:30p.m. PRESENTATION : Ken Peterson, Touchstone Enterprises; Strategic Partner, MasterControl ...

  • Hello, Please contact me at my email address (bashar@makromed.com) for more info on this inquiry. Our complaint handling system, InfoMed, designed for 21 CFR 820 compliance, has been used at several consumer products companies (ex: cosmetics) where the complaints volume is very high and complaints are received by phone calls and social media contacts. ...

  • Hi everyone, Today, I wanted to share with you some information on China's updated drug regulations: China's National Medical Products Administration (NMPA) is seeking public comments on new regulations it is drafting on drug registration, drug distribution, and manufacturing. The new regulations, updated in October by the Ministry of Justice, reflect ...

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    Distributor address change EU-Class III

    This message was posted by a user wishing to remain anonymous ​​One of our distributors is changing its legal address in USA. The address information is on the current product label (MDD-Class III). Would the change be considered significant in EU under MDD, do I need to notify our Notified Body? Thanks!!!

Volunteer Appreciation 2019

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here


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