Return-Path: <11702.ec1dc24@vmail4.newsletters.email> Received: from vps.transocean.com by vps.transocean.com with LMTP id IJ3RFkiO6Fm6WwAAInt2oQ ; Thu, 19 Oct 2017 04:36:40 -0700 Return-path: <11702.ec1dc24@vmail4.newsletters.email> Envelope-to: JOHN@TRANSOCEAN.COM Delivery-date: Thu, 19 Oct 2017 04:36:40 -0700 Received: from vmail4.newsletters.email ([66.219.28.171]:59501) by vps.transocean.com with esmtp (Exim 4.89) (envelope-from <11702.ec1dc24@vmail4.newsletters.email>) id 1e597g-000672-VV for JOHN@TRANSOCEAN.COM; Thu, 19 Oct 2017 04:36:40 -0700 DKIM-Signature: v=1; a=rsa-sha1; c=simple/simple; d=newsletters.email; s=dknewsletter; t=1508412954; bh=m91ZqXYM2AjC4jdw0XidfNcZEgE=; h=Date:From:Reply-To:To:Subject:List-Unsubscribe; b=L+HWDi4aKLNjYJc/q1Y0MqCVsk9s/U+5uHgakQDrjxB8KfAOoYMtXb98rbt01zKxb g8IYZItplYvbXTZJhqUxsKOXj+ykgitMp/vg6z4+V9qT/v6pxXaFpEBB6nu+6NorA8 YJRvlMpd3IlxE1clG2XaPcN83B/YGbdyAqtR+Mk8= Date: Thu, 19 Oct 2017 07:35:54 -0400 From: "FDA Inspections" Reply-To: "FDA Inspections" To: Subject: Communicating with the FDA and Handling FDA Warning Letters Message-ID: <11702.ec1dc24.2bee5ed9@vmail4.newsletters.email> X-MNB-TRACKING: Y29kZXJzd2ViIDogSk9ITkBUUkFOU09DRUFOLkNPTSA6IDU5ZTg1NDJjNDdmN2M2MTIyMjRlNmFhMA== X-MNB-SENDID: 59e8542c47f7c612224e6aa0 List-Unsubscribe: Feedback-ID: 2225179:2207340:newsletter:massmail Content-Type: multipart/alternative; boundary="=_59e88e1a2BEE5ED97f02000dec107F02180331F0ec1dc2411702" MIME-Version: 1.0 X-Spam-Status: No, score=-1.9 X-Spam-Score: -18 X-Spam-Bar: - X-Ham-Report: Spam detection software, running on the system "vps.transocean.com", has NOT identified this incoming email as spam. The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: Strategies for Communicating with the FDA and Handling FDA Warning Letters Presented By: Norma Skolnik Live Webinar Date: Thursday, October 25, 2017 | Duration: 60 minutes Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT REGISTER NOW Get Regulatory Insights and Tips for Successful Communication with FDA In order to successfully market drugs and dietary supplements in the U.S., it’s essential to comply with FDA regulations and communicate with the FDA successfully to obtain FDA guidance. You must also know how to handle an FDA warning letter. To obtain FDA guidance if there are regulatory issues or if you receive an FDA warning letter, it’s critical to communicate effectively with the FDA. You must have proactive and reactive strategies for FDA communication and know how to handle an FDA warning letter. 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You must also know how to hand= le an FDA warning letter. To obtain FDA guidance if there are regulatory is= sues or if you receive an FDA warning letter, it=E2=80=99s critical to comm= unicate effectively with the FDA. You must have proactive and reactive stra= tegies for FDA communication and know how to handle an FDA warning letter. In this session, expert speaker Norma Skolnik will cover strategies for eff= ective communication with FDA centers and staff. Norma will provide regulat= ory insights, know-how and tips, as well as references to all relevant FDA = regulations, guidance documents, and FDA websites. Read more Session Highlights Small business and industry assistance meetings Initial communications prior to dr=C3=B9g product launch Initial communication prior to dietary supplement launch Proactive and reactive strategies for FDA center communication Tips for avoiding and responding to an FDA Warning Letter And more Apply "PM20" at check-out to get $20 off on registration CLICK HERE TO REGISTER =20 Get answers to your questions in the Q&A directly from the speaker For Spec=C3=ACal Offers, Deals & Discounts: =E2=9C=86 Call now at 1-866-458-2965 or email at customerservice@audioeduca= tor.com (Reference cod=C3=A8: EFOOIZ0C_MB) To join our mailing list and receive invitations to similar webinars, click= here. About Our Speaker Norma SkolnikNorma Skolnik has over 35 years of regulatory experience worki= ng with the pharmaceutical and dietary supplement industries. She served as= Director of Regulatory Affairs for the Americas for Cadbury Adams. Read mo= re Follow Us On: fb tw linkedin yt Knowledge for Healthcare We hope you found this message to be useful. If you don=E2=80=99t wish to receive any further communication, please clic= k the unsubscribe link below. Your request will be processed within 10 days= .=20 This message has been sent by Audio Educator. 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Strategies for Communicating wit= h the FDA and Handling FDA Warning Letters
Presented By: Norma Skolnik
Live Webinar Date: Thursday, October 25, 2017 | Duration:<= /strong> 60 minutes
Time: 1 pm ET | 12 pm CT | 11 am= MT | 10 am PT
REGISTER NOW
Get Regulatory Insights and Tips for Successful Communication= with FDA
In order to successfully market drugs and dietary = supplements in the U.S., it’s essential to comply with FDA regulation= s and communicate with the FDA successfully to obtain FDA guidance. You mus= t also know how to handle an FDA warning letter. To obtain FDA guidanc= e if there are regulatory issues or if you receive an FDA warning letter, i= t’s critical to communicate effectively with the FDA. You must have p= roactive and reactive strategies for FDA communication and know how to hand= le an FDA warning letter.

In this session, expert speaker Norma Skolnik will cover strategies for effective communication= with FDA centers and staff. Norma will provide regulatory insights, know-h= ow and tips, as well as references to all relevant FDA regulations, guidanc= e documents, and FDA websites. Read more
Session Highlights
  • Small business and = industry assistance meetings
  • Initial communicati= ons prior to drùg product launch
  • Initial communicati= on prior to dietary supplement launch
  • Proactive and react= ive strategies for FDA center communication
  • Tips for avoiding a= nd responding to an FDA Warning Letter
  • And more
Apply "PM20" at check-out to get $20 off o= n registration
  CLICK HERE TO REGISTER  
Get answers to your questions in the Q&= ;A directly from the speaker
For Specìal Offer= s, Deals & Discounts:
=E2=9C=86 Call now at 1-86= 6-458-2965 or email at customerser= vice@audioeducator.com (Reference codè: EFOOIZ0C_MB)
<= font face=3D"Verdana" size=3D"2" color=3D"#ffffff">To join our mailing list= and receive invitations to similar webinars, click here.
About Our Speaker
3D"Norma Norma Skolnik has over= 35 years of regulatory experience working with the pharmaceutical and diet= ary supplement industries. She served as Director of Regulatory Affairs for= the Americas for Cadbury Adams. Read more
Follow Us On: 3D"fb" 3D"tw" =3D"linkedin" 3D"Knowl=
W= e hope you found this message to be useful.
If you don’t wish to= receive any further communication, please click the unsubscribe link below= . Your request will be processed within 10 days. 
This message h= as been sent by Audio Educator.
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