Return-Path: Received: from vps.transocean.com by vps.transocean.com with LMTP id mPm3Mxa/VFroQgAAInt2oQ ; Tue, 09 Jan 2018 05:09:42 -0800 Return-path: Envelope-to: john@transocean.com Delivery-date: Tue, 09 Jan 2018 05:09:42 -0800 Received: from [192.225.175.157] (port=22087 helo=ap3.audioeducatoremail.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1eYtel-0004VJ-Ut for john@transocean.com; Tue, 09 Jan 2018 05:09:42 -0800 Received: by ap3.audioeducatoremail.com with SMTP id AF036C2BC.33 for ; Tue, 09 Jan 2018 08:08:47 -0500 To: john From: "FDA Inspections" Reply-To: Subject: Communicating with the FDA and Handling FDA Warning Letters Date: Tue, 09 Jan 2018 08:08:47 -0500 Message-ID: MIME-Version: 1.0 Content-type: text/html X-Spam-Status: No, score=2.2 X-Spam-Score: 22 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: Understanding CMS-855 Forms Including the New CMS-855-POH for Hospitals and Clinics Strategies for Communicating with the FDA and Handling FDA Warning Letters Presenter Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Read more! [...] Content analysis details: (2.2 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. [URIs: coderswebinars.com] 0.0 T_SPF_TEMPERROR SPF: test of record failed (temperror) 0.0 HTML_MESSAGE BODY: HTML included in message -0.5 BAYES_05 BODY: Bayes spam probability is 1 to 5% [score: 0.0133] 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.0 T_HTML_TAG_BALANCE_CENTER Malformatted HTML 2.0 RDNS_NONE Delivered to internal network by a host with no rDNS X-Spam-Flag: NO Understanding CMS-855 Forms Including the New CMS-855-POH for Hospitals and Clinics
Strategies for Communicating with the FDA and Handling FDA Warning Letters
Presenter

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Read more!

Prerecorded Webinar

Length: 60 minutes

Price: $99

   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. It’s very important to have proactive and reactive strategies for FDA communication, especially if there are regulatory issues or if you receive 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-how and tips. She will also provide references to all relevant FDA regulations, guidance documents, and FDA websites.
Session Highlights
  • Pre-IND /NDA communications with FDA
  • Small business and industry assistance meetings
  • Initial communications prior to drùg product launch
  • Initial communication prior to dietary supplement launch
  • Proactive and reactive strategies for FDA center communication
  • Practical approaches for communicating with FDA
  • Formal advisory request process
  • Responding to FDA warning letters
Offer: $50 Off | Codè: coderswebinars50
   REGISTER NOW  

Contact Us:
 (239)-280-2397
 service@coderswebinars.com
Coders Webinars
Reference No.EFOOKDCW_RB

Click here to Unsubscribe