Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id sNeqNgZJwlqpWAAAInt2oQ for ; Mon, 02 Apr 2018 08:15:18 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Mon, 02 Apr 2018 08:15:18 -0700 Received: from mta.email.complianceonline.com ([74.122.218.171]:37913) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f31At-0005zP-F5 for charley@transocean.com; Mon, 02 Apr 2018 08:15:18 -0700 DKIM-Signature: v=1; a=rsa-sha1; d=email.complianceonline.com; s=ei0; c=simple/simple; q=dns/txt; i=@email.complianceonline.com; t=1522682036; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=LF8o3pCxROeYZGyfj94Rh8H9aaA=; b=Q1kovwVTh94JY3yfwrDkdP9dYxZ/EkXblqXaIDVQwuMKGtskbmefI7oggCKqkztp rEctuuum31kZdNegOY97Is+oTPNX2sXLMnEWcChWtuyWUXZtTiDAet9adFviVl4S jH+WrKw0de9XJVXzLXzLsg1/GtQ11BORnH2SUIoCSL4=; Received: from [10.21.250.231] ([10.21.250.231:3344] helo=CORE18PUMPER1) by pc1udsmta1n19 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id 07/2E-08005-4B842CA5; Mon, 02 Apr 2018 11:13:56 -0400 Date: Tue, 03 Apr 2018 00:13:56 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVngYQZ8oVYlyDAQUtkUt4De9TJn0tCVgMJi4EXG9As2khkVj4gw4= From: "compliance seminar" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: MDR, Complaints & Recalls Seminar by Ex-FDA Official (New course materials has been added) MIME-Version: 1.0 Content-Type: text/html; charset="us-ascii" Content-Transfer-Encoding: 7bit X-Spam-Status: No, score=0.6 X-Spam-Score: 6 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: ComplianceOnline ComplianceOnline The Largest GRC Advisory Network +1-888-717-2436 Managing Your Complaints and Obstacles in Post-Market Requirements-- Results from Top Medical Device Observations During an Inspection In-Person Seminar by Ex-FDA Official Kimpton Hotel Monaco Pittsburgh, PA | May 3-4, 2018 • View Agenda Speaker: Rita Hoffman, RAC, Managing Partner Regs & Recall Strategies, LLC By attending this seminar, you will discover: How to overcome one of the biggest obstacles device manufacturers face How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA **New course materials have been added, updated content will include: Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and What to expect from the changes in ORA with Inspection Structure Realignment Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions. Register Now 4th Annual Medical Device Summit 2018 | San Francisco, CA | June 7-8, 2018 © Copyright 2018 | 2479 East Bayshore Road, Suite 200 Palo Alto, CA 94303, USA • +1-888-717-2436 This message was sent to charley@transocean.com | Unsubscribe. [...] Content analysis details: (0.6 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: complianceonline.com] -0.0 SPF_PASS SPF: sender matches SPF record -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.0 HTML_MESSAGE BODY: HTML included in message -0.0 BAYES_40 BODY: Bayes spam probability is 20 to 40% [score: 0.2134] 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain X-Spam-Flag: NO ComplianceOnline
ComplianceOnline
The Largest GRC Advisory Network 		+1-888-717-2436
Managing Your Complaints and Obstacles in Post-Market Requirements-- Results from Top Medical Device Observations During an Inspection
In-Person Seminar by Ex-FDA Official
Kimpton Hotel Monaco Pittsburgh, PA | May 3-4, 2018 • View Agenda
Speaker: Rita Hoffman, RAC, Managing Partner Regs & Recall Strategies, LLC
By attending this seminar, you will discover:
  • How to overcome one of the biggest obstacles device manufacturers face
  • How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
  • How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall
  • How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA
**New course materials have been added, updated content will include:
  • Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and
  • What to expect from the changes in ORA with Inspection Structure Realignment
Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.
Register Now
4th Annual Medical Device Summit 2018 | San Francisco, CA | June 7-8, 2018
© Copyright 2018 | 2479 East Bayshore Road, Suite 200 Palo Alto, CA 94303, USA • +1-888-717-2436
This message was sent to charley@transocean.com | Unsubscribe.