ComplianceOnline

Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id gLOiATqZw1osZgAAInt2oQ for ; Tue, 03 Apr 2018 08:09:46 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Tue, 03 Apr 2018 08:09:46 -0700 Received: from mta.email.complianceonline.com ([198.31.63.221]:45868) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f3NZ4-0007LE-3j for charley@transocean.com; Tue, 03 Apr 2018 08:09:45 -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=1522768137; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=FhrJHbHMNVt+zyAJ9ibuWgxQxGc=; b=SbvjnCu3/DTPDxP2KZOIo0DE/ohAulyUstdQ1veb8neN54Baj9a8nN3Ueq6Fi4sL XxbJ9f0KwV8bRjhrM6eXafSL0Fj5ODAtEuwNMOHZo7C1QbGlInDcdPgzisjWnSf4 orzzoOYoidJPcirjQysKhwndv2P6ML+WQ5tb7ZWqFK4=; Received: from [10.21.250.231] ([10.21.250.231:2580] helo=CORE18PUMPER1) by pc1udsmta1n16 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id 4F/DC-17183-90993CA5; Tue, 03 Apr 2018 11:08:57 -0400 Date: Wed, 04 Apr 2018 00:08:56 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVnmUQZ8qUYlyDbwUtkUt4De9kj0ItCVgN95IEXG9As2khkXXh8OY= From: "compliance seminar" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: Supplier Management for Medical Device Manufacturers | Join us in SFO 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 Supplier Management for Medical Device Manufacturers 2-Day In-Person Seminar DoubleTree by Hilton San Francisco Airport, CA | May 03-04, 2018 • View Agenda Speaker: Dan O'Leary, President at Ombu Enterprises, LLC This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program. [...] 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 -0.0 BAYES_20 BODY: Bayes spam probability is 5 to 20% [score: 0.0822] 0.0 HTML_MESSAGE BODY: HTML included in message 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 X-Spam-Flag: NO ComplianceOnline

ComplianceOnline
The Largest GRC Advisory Network

+1-888-717-2436

Supplier Management for Medical Device Manufacturers
2-Day In-Person Seminar

DoubleTree by Hilton San Francisco Airport, CA | May 03-04, 2018 • View Agenda

Speaker: Dan O'Leary, President at Ombu Enterprises, LLC

This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program.

This two-day hands-on workshop provides a clear understanding of the underlying principles of supplier management, using exercises to help illustrate the points and solidify understanding. In addition, the course uses FDA Warning Letters to raise issues and help you learn from others. As part of the practical implementation, the course includes supplier evaluation and selection; measuring, monitoring, and re-evaluation; outsourced processes; supplier auditing techniques; and supplier issues in management review.

The workshop uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other important issues and techniques. The course includes information from the ISO 13485:2016 Handbook, FDA's QSIT, and the MDSAP Audit Model.

Register Now

Learning Objectives:

Upon course completion, participants will:

Understand FDA QSR and ISO 13485:2016 requirements for supplier management
Learn FDA’s inspection techniques from QSIT
Understand supplier management tasks from the MDSAP Audit Model
Understand the FDA’s multi-tier supplier classification system
Understand when suppliers have to register and list with the FDA
Use an analysis matrix and radar chart to compare suppliers
Explain the link between design control and purchasing data
Develop an overall supplier management plan
Understand how to develop and implement supplier controls
Create receiving inspection criteria and apply them as part of supplier controls
Create supplier measurement, monitoring, and re-evaluation processes
Create a system for supplier business risk
Create a system for supplier regulatory risk
Create a risk based system for supplier audits
Develop a supplier audit using the backward tracing process approach

Speaker Profile:

Daniel O'Leary has more than 30 years' experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master's Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

View Details

4th Annual Medical Device Summit 2018 | San Francisco, CA | June 7-8, 2018