Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id aGSrKLIH1lq6UAAAInt2oQ for ; Tue, 17 Apr 2018 07:41:54 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Tue, 17 Apr 2018 07:41:54 -0700 Received: from mta036b.pmx1.epsl1.com ([142.54.244.36]:53287) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f8Rnn-0005br-Hm for charley@transocean.com; Tue, 17 Apr 2018 07:41:54 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=simple/simple; d=info.grcseminars.com; s=ep1; t=1523976060; bh=Y2VlV2p63VJWzTTmFeVH/6nyK7Nh1sx07UI30jQdWeU=; h=MIME-Version:Subject:From:To:Date:Content-Type; b=en62+ewc/uefuWiDWaRYJNGnQgh9wZwBtivfhqePqybPFWAF7mwWUjFE+SXjprhZ2 ZixUT01Z456Nje0gz8QUQvxML7o1N04e0GG7O+/bZslYgy9psqF1pjAvEBIyqaFNf0 2wmQHCH+ViioSyjKbYvOrhqw0CmFkFaEiQOrE6PY= Received: from [10.233.18.116] ([10.233.18.116:43026]) by pc1udsmtn1n12 (envelope-from ) (ecelerity 3.6.9.48312 r(Core:3.6.9.0)) with ECSTREAM id 89/C5-43926-C7706DA5; Tue, 17 Apr 2018 14:41:00 +0000 List-Unsubscribe: Message-ID: MIME-Version: 1.0 Reply-To: "training@info.grcseminars.com" Subject: FDA Post Market Regulations | Workshop by Ex-FDA Officials From: GRC Seminars To: charley@transocean.com Date: Tue, 17 Apr 2018 14:41:00 +0000 Content-Type: multipart/alternative; boundary="-=Part.1a3a6b0.5521f224a14f7942.162d40d402d.c70772e38745b82f=-" 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: GRC Seminars GRC Seminars +1-888-771-6965 Understanding FDA Post Market Regulations 3-Day Workshop by Ex-FDA Officials By: Casper E. Uldriks & Rita Hoffman | San Francisco, CA | May 23-24-25, 2018 VIEW AGENDA Former FDA Directors will explain how participants can mitigate the risk of regulatory enforcement actions; avoid future recalls by using the Total Product Life Cycle TPLC paradigm that CDRH uses. Course materials include creating Standard Operating Systems for Post-Market Quality Systems, how risk guidance document intertwines with Recalls and ORA Inspection Realignment Structure. This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that has only been offered by Casper Uldriks and Rita Hoffman, who bring over 68 years of combined experience. Learning Objectives: Learn about the FDA's agency-wide legal and procedural steps and investigational operations for post market issues Understand how to comply with complicated Compliant Handling, MDR and Recall requirements Firms MDR reporting and FDA's handling of MDR reports Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA Minimize your risk of regulatory enforcement actions Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events Walk-through of case examples Step-By-Step guide to designing Standard Operating Systems for communicating process for firm's success Discussion of FDA's New Guidance's on Risk and how it interacts with Recalls Meet Your Instructors: [...] 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: grcseminars.com] -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] 0.8 MPART_ALT_DIFF BODY: HTML and text parts are different 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 0.0 MIME_HTML_ONLY_MULTI Multipart message only has text/html MIME parts X-Spam-Flag: NO ---=Part.1a3a6b0.5521f224a14f7942.162d40d402d.c70772e38745b82f=- Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset=UTF-8 GRC Seminars =20

GRC+1-888-771-69= 65
= Understanding FDA Post Market Regulations
3-Day Workshop by = Ex-FDA Officials
By: Casper E=2E Uldriks & Rita Hof= fman | San Francisco, CA | May 23-24-25, 2018
VIEW AGENDA
Former FDA Directors wil= l explain how participants can mitigate the risk of regulatory enforcement = actions; avoid future recalls by using the Total Product Life Cycle TPLC pa= radigm that CDRH uses=2E Course materials include creating Standard Operati= ng Systems for Post-Market Quality Systems, how risk guidance document inte= rtwines with Recalls and ORA Inspection Realignment Structure=2E This Semin= ar will have you stop spinning your wheels with nonessential activities, an= d leave you with a comprehensive learning package that has only been offere= d by Casper Uldriks and Rita Hoffman, who bring over 68 years of combined e= xperience=2E
Learning Objectives:
  • Learn about the FDA's agency-wide legal and procedural steps and inves= tigational operations for post market issues
  • Understand how to comply with complicated Compliant Handling, MDR and = Recall requirements
  • Firms MDR reporting and FDA's handling of MDR reports
  • Company preparation in the event of a Recall, recall strategy, notific= ation letter and communicating with the FDA
  • Minimize your risk of regulatory enforcement actions
  • Assist with the creation and maintenance of effective procedures for h= andling complaints, reportable events and recalls
  • Understand the relationship and interaction with other quality system = elements as they relate to complaints and reportable events
  • Walk-through of case examples
  • Step-By-Step guide to designing Standard Operating Systems for communi= cating process for firm's success
  • Discussion of FDA's New Guidance's on Risk and how it interacts with R= ecalls

Meet Your Inst= ructors:

Casper Uldriks, Former= Associate Center Director of FDA's CDRH

Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent= 32 years in FDA and his engagements focus on advertising and promotion, re= calls, corrections and removals and enforcement=2E He understands how FDA t= hinks, how it operates and where it is headed=2E Based on his exceptionally= broad experience and knowledge, he can synthesize FDA=E2=80=99s domestic a= nd international operational programs, institutional policy and thicket of = legal variables into a coherent picture=2E

Rita Hoffman , RAC, Ma= naging Partner Regs, Former FDA CDRH Recall Branch Chief=2E

Rita Hoffman retired from the FDA in January 2011 as the Recall Branch = Chief for the Center for Devices and Radiological Health (CDRH), where she = was responsible for oversight and review for all medical device recalls=2E = Ms=2E Hoffman held several positions including the Center for Drug Evaluati= on and Research (CDER) Jurisdiction Review Officer (providing guidance on d= rug/device product designation, combination products and co-packaging), Act= ing Associate Ombudsman, Small Business Liaison, and was a Policy Analyst f= or eight years in the Office of the Commissioner=2E
View Details
=C2=A9 Copyright 2018 | 2479 East Bayshore Road, Suite 200 = Palo Alto, CA 94303, USA | +1-888-771-6965
This message was sent to charley@transocean=2Ecom | Unsubscribe=2E
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