Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id 4KhcEFgVzlpeJwAAInt2oQ for ; Wed, 11 Apr 2018 07:02:00 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Wed, 11 Apr 2018 07:02:00 -0700 Received: from mta036b.pmx1.epsl1.com ([142.54.244.36]:37048) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f6GJs-0002hv-67 for charley@transocean.com; Wed, 11 Apr 2018 07:02:00 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=simple/simple; d=info.grcseminars.com; s=ep1; t=1523455264; bh=HZwaRQFGlQG1+jL5X37V9msrJgg+4Yal5e0dNqrG7Dw=; h=MIME-Version:Subject:From:To:Date:Content-Type; b=Mzd2AF/WkTmbyi1nzpTtaqtQdmSoZ5a7i5bQEuRZoXN3fEqoM7Sv48a3wrTtj6C0c 9t5PsuS9sTbEojYegpbN/eQHgRoc/dGLi2G9tNdHJdmzP7bKmb9yduzUsP0GQD/j4a oFPknMBf3VzEaoKh1DLxm271Ib2/1IIm3FHuqFpU= Received: from [10.233.19.80] ([10.233.19.80:34022]) by pc1udsmtn1n17 (envelope-from ) (ecelerity 3.6.9.48312 r(Core:3.6.9.0)) with ECSTREAM id BE/B0-43501-0251ECA5; Wed, 11 Apr 2018 14:01:04 +0000 List-Unsubscribe: Message-ID: MIME-Version: 1.0 Reply-To: "training@info.grcseminars.com" Subject: FDA Compliance Risk Management Seminar: Learn ISO 14971, 13485, 31000 & cGMP From: GRC Seminars To: charley@transocean.com Date: Wed, 11 Apr 2018 14:01:04 +0000 Content-Type: multipart/alternative; boundary="-=Part.1f2f94.b2c81054c58dfe5b.162b5028619.3fc9b70f1e942ac8=-" 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 In-Person Seminar Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products By: Stan Mastrangelo | Boston, MA | May 17-18, 2018 VIEW AGENDA In this workshop, you will learn how to implement effective Compliance Risk Management in your organization. It is important that key personnel understand what a successful implementation of both ERM and Product Risk Management (ISO 14971) looks like. There are existing tools that may be adapted to implement the new requirements efficiently. Learning Objectives: Read and understand what the expectations are for manufacturers of Medical Devices, Pharmaceuticals, and Combination Products that will be regulated by ISO 13485 Understand how to utilize a risk-based approach to addressing Compliance Risk Management requirements Evaluate the effectiveness of Risk Management for Compliance and Product (ISO 14971) Develop appropriate Acceptability Criteria for Product and Compliance Risk Management Discriminate between the expectations of Medical Devices, Pharmaceuticals, and Combination Products Implement new or revised tools for improving Risk Management outcomes, both audit and field performance Meet Your Instructor: [...] 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 0.8 MPART_ALT_DIFF BODY: HTML and text parts are different 0.0 HTML_MESSAGE BODY: HTML included in message 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4986] 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 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 0.0 MIME_HTML_ONLY_MULTI Multipart message only has text/html MIME parts X-Spam-Flag: NO ---=Part.1f2f94.b2c81054c58dfe5b.162b5028619.3fc9b70f1e942ac8=- Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset=UTF-8 GRC Seminars =20

GRC+1-888-771-69= 65
In-Person = Seminar
Compliance Risk Management in Medical Devi= ces, Pharmaceuticals, and Combination Products
By: Stan Mastrangelo | Boston, MA = | May 17-18, 2018
VIEW AGENDA=
In this workshop, you wi= ll learn how to implement effective Compliance Risk Management in your orga= nization=2E It is important that key personnel understand what a successful= implementation of both ERM and Product Risk Management (ISO 14971) looks l= ike=2E There are existing tools that may be adapted to implement the new re= quirements efficiently=2E
Learning Objective= s:
  • Read and understand what the expectations are for manufacturers of Med= ical Devices, Pharmaceuticals, and Combination Products that will be regula= ted by ISO 13485
  • Understand how to utilize a risk-based approach to addressing Complian= ce Risk Management requirements
  • Evaluate the effectiveness of Risk Management for Compliance and Produ= ct (ISO 14971)
  • Develop appropriate Acceptability Criteria for Product and Compliance = Risk Management
  • Discriminate between the expectations of Medical Devices, Pharmaceutic= als, and Combination Products
  • Implement new or revised tools for improving Risk Management outcomes,= both audit and field performance

Meet Your Inst= ructor:

Stan Mastrangelo, Tec= hnical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q= 9 Standards

Stan Mastrangelo has over 30 years of professional work experience in Q= uality Assurance of medical devices, pharmaceuticals, and foods=2E Stan has= held positions such as Senior Quality Engineer, Corporate Quality Assuranc= e Auditor, Plant QA Manager, QA Director, and Consultant=2E Stan was a memb= er of the ANSI Executive Standards Board=2E Stan has had extensive involvem= ent in the development of International Risk Management Standards=2E Stan w= as a member of the ISO Joint Working Group for Risk Management of Medical D= evices (that developed ISO/IEC14971)=2E
View Details
Copyright 2018 | 2479 East Bayshore Road, Suite 200 Palo Al= to, CA 94303, USA | +1-888-771-6965
= This message was sent to charley@transocean=2Ecom | Unsubscribe=2E
---=Part.1f2f94.b2c81054c58dfe5b.162b5028619.3fc9b70f1e942ac8=---