Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id yCDSHCvHxFoCOgAAInt2oQ for ; Wed, 04 Apr 2018 05:38:03 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Wed, 04 Apr 2018 05:38:03 -0700 Received: from mta.email.complianceonline.com ([198.31.63.221]:41799) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f3hfo-00042v-FD for charley@transocean.com; Wed, 04 Apr 2018 05:38:03 -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=1522845436; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=Rkvbs8hMrIYboeCtanx6qCSIVd4=; b=ystAHPOXICwy0Gr/q6xz4cMXbjKa3RicB1OXdgDZi6NCUyh+eFomBHynAHclHt0T Vdm+mzOTIhRjDlaeeQVsCPrDY3DU4aMDHSxYX8rislZbLwEewwcDHlHFlSmqLEjj 1sqV9QUzHCxpyUeR8Pi6K38xUm0DTEkFMwZv1NW61lo=; Received: from [10.21.250.232] ([10.21.250.232:4956] helo=CORE18PUMPER2) by pc1udsmta1n25 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id C6/6C-04643-CF6C4CA5; Wed, 04 Apr 2018 08:37:16 -0400 Date: Wed, 04 Apr 2018 21:37:16 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVnVkQZ8t1YlyDtQUtkUt4De9vPNotCVgKqGYEXG9As2khkSF-qTM= From: "Compliance Training" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: Effective (and FDA Compliant) Management Reviews MIME-Version: 1.0 Content-Type: text/html; charset="us-ascii" Content-Transfer-Encoding: 7bit X-Spam-Status: No, score=1.4 X-Spam-Score: 14 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 Effective (and FDA Compliant) Management Reviews Friday, April 20, 2018 | 08:00 AM PDT (60 Min) • View Details Speaker: Larry Stevens, RAC Principal Consultant, FDA Regulatory Expert Use code WEB10 to get 10% off on registration; valid till Friday, April 13, 2018. Medical device industry professional like you are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820. However the regulation is not very specific on how to set up an effective management review procedure. Merely to hold a management review to please the regulators will in most cases be a waste of time. But by establishment of effective management reviews will be a valuable tool to allow Senior Management to be more effective. [...] Content analysis details: (1.4 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 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4028] -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
Effective (and FDA Compliant) Management Reviews
Friday, April 20, 2018 | 08:00 AM PDT (60 Min) • View Details
Speaker: Larry Stevens, RAC Principal Consultant, FDA Regulatory Expert
Use code WEB10 to get 10% off on registration; valid till Friday, April 13, 2018.

Medical device industry professional like you are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820. However the regulation is not very specific on how to set up an effective management review procedure. Merely to hold a management review to please the regulators will in most cases be a waste of time. But by establishment of effective management reviews will be a valuable tool to allow Senior Management to be more effective.

We invite you to this webinar to understand all the essential elements for effective management review. Discussion will be done on key requirements for the procedure, and how to schedule management reviews. We will also discuss how to measure the effectiveness of your management review program.

Areas Covered:
  • What is the regulation?
  • What does FDA expect?
  • What are the key elements of a Management Review procedure?
  • What data should be reviewed?
  • How often should the review occur
  • Who should attend the review
  • How do you measure the effectives of the review?
Register Now

Registration Information:
One Dial-in One Attendee
$179
Group - Max. 10 Attendees/Location
(Super Deal: CD/USB Drive Free!)
$449
Combo 1: Live + Recorded
$299
Combo 2: Live + Training CD/USB
$349
Recorded Version Only
$229
Training CD / USB Drive Only
$299

Speaker Profile:

J. Lawrence Stevens, RAC, who has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry.
View Details
4th Annual Medical Device Summit 2018 | San Francisco, CA | June 7-8, 2018
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