ComplianceOnline

Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id yJPCGBuz2FpJZQAAInt2oQ for ; Thu, 19 Apr 2018 08:17:47 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Thu, 19 Apr 2018 08:17:47 -0700 Received: from mta.email.complianceonline.com ([198.31.63.221]:16569) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f9BJb-0006wC-Un for charley@transocean.com; Thu, 19 Apr 2018 08:17:47 -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=1524151015; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=JsUmSbwsYfiGdmUb1mY4W5rRkL0=; b=tSb4P2gdw1C4/2wuNu43r4HTxw/JpQ+V5VYXhBaeTE7mBZNdXTx8mp5bilz9RQkG AQWyysuwkTlayxpggkA3g6iX6i1ZRwECR4aVec9jEhT6F/f4QgD0s1d7lSmZvx3a 40sGldAtiiqkYr1yb57DXNi7SXXMWY3Q1VPmipTjHIQ=; Received: from [10.21.250.232] ([10.21.250.232:4455] helo=CORE18PUMPER2) by pc1udsmta1n19 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id F6/F3-10946-7E2B8DA5; Thu, 19 Apr 2018 11:16:55 -0400 Date: Fri, 20 Apr 2018 00:16:55 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVnTEQZ9Y3YlyPAwUtkUt4De-UkBUtCVgW3H0EXG9As2khkT8BqqA= From: "compliance seminar" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: Former FDA Director Teaches Compliance Best Practices for QC Laboratories 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 Quality Control Laboratory Compliance - cGMPs and GLPs In-Person Seminar by Ex-FDA Official Philadelphia, PA | May 31 - June 1, 2018 • View Agenda Speaker: Robert C Fish, Consultant, EAS Consulting Group, (Former FDA Director) This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay "current" with FDA requirements (cGMPs and GLPs). [...] 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 HTML_MESSAGE BODY: HTML included in message 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4990] 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 -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature X-Spam-Flag: NO ComplianceOnline

ComplianceOnline
The Largest GRC Advisory Network

+1-888-717-2436

Quality Control Laboratory Compliance - cGMPs and GLPs
In-Person Seminar by Ex-FDA Official

Philadelphia, PA | May 31 - June 1, 2018 • View Agenda

Speaker: Robert C Fish, Consultant, EAS Consulting Group, (Former FDA Director)

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay "current" with FDA requirements (cGMPs and GLPs).

Register Now

Learning Objectives:

Key goals of the conference will include learning:

The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
Laboratory organization, personnel qualification and training requirements.
Documentation and record-keeping requirements, including e-records and data integrity.
Sample integrity requirements.
Management and control of stability (shelf-life) studies.
Analytical methods verification and validation.
Management and control of laboratory instruments.
Management and control of laboratory supplies.
Proper conduct of laboratory investigations.
Consequences of laboratory non-compliance.

Speaker Profile:

Mr. Fish has served 33 years with Food and Drug Administration (FDA). The last 6 years of that service he held the position of Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency's domestic and international investigation activities. He also managed the foreign inspections' operations.

View Details

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