Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id gDUIM3q+xFpZLQAAInt2oQ for ; Wed, 04 Apr 2018 05:00:58 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Wed, 04 Apr 2018 05:00:58 -0700 Received: from mta.email.complianceonline.com ([198.31.63.221]:41327) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f3h5v-00032P-DI for charley@transocean.com; Wed, 04 Apr 2018 05:00:58 -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=1522843205; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=HEOfVuM2Ls/di7ce3azvYlN/hpc=; b=01TcxIUzWvJdYRNYL+xNXGS/dIAcyXsbcMl7JEtX/XXcQQnj9A2BxQxgQQV1DzFb M4Y4JqnQ6xN+oHKx0Gl2XsnPNC4uqqE54EeANB4dct+h+eSM86l4NlucFHr+5B5L fN8ZYoZeSdpGlRumR+ocBljYuQENw721pC1gSFvR0kU=; Received: from [10.21.250.232] ([10.21.250.232:4811] helo=CORE18PUMPER2) by pc1udsmta1n25 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id CC/76-04643-54EB4CA5; Wed, 04 Apr 2018 08:00:05 -0400 Date: Wed, 04 Apr 2018 21:00:05 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVnSQQZ8tDYlyD0QUtkUt4De9qRiYtCVgK0N8EXG9As2khkfMnbTA= From: "compliance seminar" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: FDA Analytical Methods Development & Validation Activities | Early Registration open 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 A Risk Based Scientific Approach to Analytical Methods Development and Validation Activities for FDA Regulated Industries 2-Day In-Person Seminar San Francisco, CA -- June 14-15, 2018 • View Agenda Speaker: Dr. Shib Mookherjea, Validation Expert and Management Consultant This Course introduces the schematics of Methods Development and Validation with a grassroot, conceptual standpoint, based on scientific rationale and a Method by Design approach, a concept akin to QbD. The aim is to lead the audience to the understanding, basic elements of analytical method, with a focus on Quality. At the outset, it implores the analytical chemist to grasp an Analytical Method as a process of measurement. [...] 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: 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 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4498] 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 -0.1 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
A Risk Based Scientific Approach to Analytical Methods Development and Validation Activities for FDA Regulated Industries
2-Day In-Person Seminar
San Francisco, CA -- June 14-15, 2018 • View Agenda
Speaker: Dr. Shib Mookherjea, Validation Expert and Management Consultant
This Course introduces the schematics of Methods Development and Validation with a grassroot, conceptual standpoint, based on scientific rationale and a Method by Design approach, a concept akin to QbD. The aim is to lead the audience to the understanding, basic elements of analytical method, with a focus on Quality. At the outset, it implores the analytical chemist to grasp an Analytical Method as a process of measurement.

This Course is highly interactive and participative. Attendees are encouraged to interact and be prepared to bring examples of Analytical Development and Validation issues, which will be discussed during the second day. A class breakout session (for about 2 hours) is normally included, wherein the attendees will be expected to participate in solving assignments of group exercise. This workshop style session requires and demonstrates the practical applications of the concepts learnt during the two days. Over the years, thousands of attendees have enjoyed and appreciated this breakout session immensely
Register Now

Learning Objectives:
  • Increase your knowledge of conformity assessment, QC/QA in the pharmaceutical laboratory
  • Increase your knowledge about cGMP/EMEA/ICH/WHO compliance issues
  • Consult with a knowledgeable instructor about your current technical problems and preparation and requirements for submission of regulatory packages (NDA, ANDA, IND, MMA and others for FDA & OECD)
  • Learn a generic approach for developing an analytical method and optimizing it
  • Become acquainted with practical approaches for validating new analytical procedures
  • Familiarize yourself with methods development and optimization in HPLC
  • Be exposed to the latest international requirements and guidelines: ICH, ISO 17025, OECD, & FDA guidelines for analytical validation
  • Learn about the FDA's new initiatives in systems-based inspection and risk-based assessment
  • Understand the training and supervision requirements of chemists and technicians and other lab personnel for GLP
  • Receive helpful hints to help prepare you for a visit from an auditor's perspective
  • Learn about general validation and qualification requirements for analytical instruments such as HPLC, TOC, CE, LC-MS, AA, UC/VIS, dissolution and other emerging techniques
Speaker Profile:

Dr. Shib Mookherjea has extensive experience in R&D, Validation and Compliance Issues for Pharma, Biotech and Medical Device Industries; Quality Assurance, Quality Management and Quality Control in Pharma and Medical Device. Over the last 20+ years, he has conducted hundreds of these Training sessions in more than 25 countries, to more than 8,000 attendees.
View Details
4th Annual Medical Device Summit 2018 | San Francisco, CA | June 7-8, 2018
© Copyright 2018 | 2479 East Bayshore Road, Suite 200 Palo Alto, CA 94303, USA | +1-888-717-2436
This message was sent to charley@transocean.com | Unsubscribe.