Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id mNnbIBOvr1ouYQAAInt2oQ for ; Mon, 19 Mar 2018 05:37:39 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Mon, 19 Mar 2018 05:37:39 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:47823 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1exu2d-0006UF-LJ for louk@transocean.com; Mon, 19 Mar 2018 05:37:39 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=grceducators; d=news.grceducators.com; h=MIME-Version:Content-Type:Content-Transfer-Encoding:Date:To:From:Reply-To: Subject:List-Unsubscribe:Message-ID; i=grceducators@news.grceducators.com; bh=MNYUuEidp4hHZpa4mLFCLtlxw2xmk4QOquRA4BNeS68=; b=wevPwVlhbr3DFKdPGkTOhZ3OghOuDZuUFwufp2HhAHOyWU4k3q5QWcKHRXw5hKi0g7WsmfdX5TFq rHodJdNWxphSUjQr4E94UFUtBiXfhBs1T5IGoJKwkzO8U8XUk5P9H2Mhx8qH+4nhijz2WTXwG1b1 H9bsK+yZOGBkZPm7rRMwZWW+HfuY6q4nj3++ym6D4vBBoTzGCw8lYO0e44h/LAFraFnMY0NQjSE0 dxfoLAJIVBxblAnTVJUcjMPD5dffbKzwQxenGU35TI6DXQ+LllEdjSwmUqLe4w+/qny1YJ6fJKwo xukx6mj2WcPHFaHGH7QZhHh0aUc7pSnl/ExqWw== Received: by om-axonstech.rsys2.com id hlungo2b610b for ; Mon, 19 Mar 2018 05:36:51 -0700 (envelope-from ) X-CSA-Complaints: whitelist-complaints@eco.de MIME-Version: 1.0 Content-Type: text/html; charset="ISO-8859-1" Content-Transfer-Encoding: quoted-printable Date: Mon, 19 Mar 2018 05:36:51 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Subject: GXP/GMP Requirments and its Consequences For Documentation and Information Technology Systems Feedback-ID: 10775:125862:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.EqIHUn8mHPqYSECEhr3HZOvZaUDzN9qjpMDafQNwMAVClb0 X-cid: axonstech.125102 Message-ID: <0.1.57.3AA.1D3BF7EF4C89440.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=2.4 X-Spam-Score: 24 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: GXP/GMP Requirements - Documentation and Information Technology Systems 740-870-0321 GXP/GMP Requirements and its Consequences for Documentation and Information Technology Systems [...] Content analysis details: (2.4 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: grceducators.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_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4658] 0.0 HTML_MESSAGE BODY: HTML included in message 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 1.0 FROM_EXCESS_BASE64 From: base64 encoded unnecessarily X-Spam-Flag: NO <=21DOCTYPE html PUBLIC =22-//W3C//DTD XHTML 1=2E0 Transitional//EN=22 =22h= ttp://www=2Ew3=2Eorg/TR/xhtml1/DTD/xhtml1-transitional=2Edtd=22> GXP/GMP Requirements - Documentation and Information Technology S= ystems <=21--=5Bif gte mso 11=5D><=21=5Bendif= =5D--><=21--=5Bif =21mso=5D><=21--> <=21--<=21=5Bendif=5D--><=21--=5Bif gte mso 15=5D>96<=21=5Bendif=5D--><=21--=5Bif gte mso 9=5D>96<=21=5Bendif=5D-->
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740-870-0321
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GXP/GMP Requirements and its Cons= equences for Documentation and Information Technology Systems
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TUESDAY APRIL 10 2018 =7C 01:00 PM EST =7C 90 MINU= TES
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Documentation is a critical tool for ensuring GxP/GMP= compliance=2E

In the regulated environment which must be GxP/GMP compliant= , document control is the cornerstone of the quality system=2E It is so imp= ortant that if an external audit identifies deficiencies in the document co= ntrol system, the entire organization can be shut down=2E

There are also GMP requirements for information technology= =2E For a drug to be produced in a GxP/GMP compliant manner, some specific = information technology practices must be followed=2E Computer systems invol= ved in the development, manufacture, and sale of regulated product must mee= t certain requirements=2E

Change control within quality management systems (QMS) and i= nformation technology (IT) systems is a formal process used to ensure that = changes to a product or system are introduced in a controlled and coordinat= ed manner=2E In the regulated industries, manufactures are required to use = a change control procedure=2E

In this webinar, the connection between GxP/GMP and document= control will be discussed=2E Details of document control procedures and th= e role of Quality Assurance in the documentation systems are described=2E G= MP requirements for information technology and how computer systems includi= ng documentation management systems must meet GxP/GMP requirements will be = reviewed=2E There is also a review of change control procedure and how it s= hould be used in GxP/GMP environment=2E
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REGISTER NOW
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Event Marketing =7C GRC Educators =7C 740-870-0321 =7C support=40grcedu= cators=2Ecom =7C www=2Egrceducators=2Ecom =7C 806 Clark Street, P=2EO Box 1= 71, Philo, OH-43771 USA
 
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© 2018 GRC Educators
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