Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id EOhrD+sYxlrrVgAAInt2oQ for ; Thu, 05 Apr 2018 05:39:07 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Thu, 05 Apr 2018 05:39:07 -0700 Received: from mta.email.complianceonline.com ([198.31.63.221]:51969) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f44AN-0005u5-QJ for charley@transocean.com; Thu, 05 Apr 2018 05:39:07 -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=1522931885; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=saMvWgB7q31bBGRtUPABOL40tW8=; b=jxCcldou9UD7jxLKN6x8EgLkna8TI2sjybFLIMuBb7zae8b9K502Y66rq8in2unZ 8gSCe4elEiLtE6nhmbHEvFnaxKYV9YQd77/Ks7YUtkAWiEh5TL8IFHMTX5HM2+yg VPhye45Mh4VI+HkZj0oDBPemUTy3eAGYerkfYJNXJgc=; Received: from [10.21.250.232] ([10.21.250.232:4608] helo=CORE18PUMPER2) by pc1udsmta1n16 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id F4/80-17183-DA816CA5; Thu, 05 Apr 2018 08:38:05 -0400 Date: Thu, 05 Apr 2018 21:38:04 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVnQAQZ8vlYlyMHQUtkUt4De8APwAtCVgIdjYEXG9As2khkeHarOY= From: "compliance seminar" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: Learn from Ex-FDA: How FDA Thinks, Operates & Where it is Headed MIME-Version: 1.0 Content-Type: text/html; charset="us-ascii" Content-Transfer-Encoding: 7bit X-Spam-Status: No, score=-1.3 X-Spam-Score: -12 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 FDA Inspection: Before, During and After 2-Day In-Person Seminar by Ex-FDA Official San Francisco, CA | June 28-29, 2018 • View Agenda Speaker: Casper E. Uldriks, Former Associate Center Director of FDA's CDRH The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection. [...] Content analysis details: (-1.3 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: transocean.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 -1.9 BAYES_00 BODY: Bayes spam probability is 0 to 1% [score: 0.0029] -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain -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 X-Spam-Flag: NO ComplianceOnline
ComplianceOnline
The Largest GRC Advisory Network 		+1-888-717-2436
Managing Your FDA Inspection:
Before, During and After
2-Day In-Person Seminar by Ex-FDA Official
San Francisco, CA | June 28-29, 2018 • View Agenda
Speaker: Casper E. Uldriks, Former Associate Center Director of FDA's CDRH
The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.

Speaker Profile:

Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.

He understands how FDA thinks, operates and where it is headed. Register Now
4th Annual Medical Device Summit 2018 | San Francisco, CA | June 7-8, 2018
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