Return-Path: Received: from vps.transocean.com by vps.transocean.com with LMTP id cK5fJ24q11pgKgAAInt2oQ ; Wed, 18 Apr 2018 04:22:22 -0700 Return-path: Envelope-to: JOHN@TRANSOCEAN.COM Delivery-date: Wed, 18 Apr 2018 04:22:22 -0700 Received: from mail198.saveastamp.com ([199.68.176.198]:44050) by vps.transocean.com with esmtps (TLSv1:ECDHE-RSA-AES256-SHA:256) (Exim 4.89_1) (envelope-from ) id 1f8lA7-0002re-0h for JOHN@TRANSOCEAN.COM; Wed, 18 Apr 2018 04:22:22 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=key; d=PharmaNewsUpdate.com; h=From:To:Reply-To:Date:Subject:MIME-Version:Content-Type:List-Unsubscribe:Message-ID; i=ericm@pharmanewsupdate.com; bh=f5mSvs9bkFeJ0sRgkRVwtWNnVLS++qEFDBAmhKA5ErU=; b=PQ3ClA/0AMB3WxuLtFtIQnvxou9EOztRQUi/Fe0QQfIQeGPdgjAxBXpDLKgxDAFfk6nLYjVEwIb7 32wy0DLTBk66MvJMATMRPexHwExrbZYL+RezTqbXAbkBN2NhCXD5xdeFq0DgL0jkJqhMEkXaQbXS IiMn6ZYAErJwZ9o0WZQNChpnxV/dZ7HD8w/tcseNbED+jC9ATE/g24McFNQ3MVkkWrfl3beUpKM8 H+NqU0NSbY3Hn7rloH5db1i5kOc+vBWIDyZYsKmH57Aqa0NVXjiD2QFVggNkvLPO9BREFWDDBPRN /tRuOPjzQTrC95OXFJMlItb5AIvbrA40LiKDoQ== Received: by mail198.saveastamp.com id hqsl501hso8r for ; Wed, 18 Apr 2018 07:20:36 -0400 (envelope-from ) From: "FDA Regulatory Compliance" To: "JOHN@TRANSOCEAN.COM" Reply-To: ericm@pharmanewsupdate.com Date: Wed, 18 Apr 2018 07:12:09 -0400 Subject: =?UTF-8?Q?2018=20Update:=20How=20to=20Write=20Effective=20SOPs=20for=20?= =?UTF-8?Q?FDA=20Inspection=20=26=20Regulatory=20Compliance?= MIME-Version: 1.0 Content-Type: multipart/alternative; boundary="_=aspNetEmail=_3404afe77ea44731a16c9061e853384e" X-Mailer: aspNetEmail ver 3.5.2.0 x-sbe: SBE_925a64e8-44a1-46e6-9751-aac6432e6aa6 List-Unsubscribe: mailto:ericm@pharmanewsupdate.com List-Unsubscribe-Post: List-Unsubscribe=One-Click Message-ID: X-Spam-Status: No, score=1.7 X-Spam-Score: 17 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: 2018 Update: How to Write Effective SOPs for FDA Inspection and Regulatory Compliance Presented By: Angela Bazigos Live Webinar Date: Friday, June 01, 2018 | Duration: 90 minutes Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT REGISTER NOW Train Personnel on SOPs That Are Consistent & Straightforward Virtually every Food and Drùg Administration (FDA) inspection includes a review of standard operating procedures (SOPs). And adverse agèncy findings are often the rèsult of SOP administration issues. SOPs are required by law for some companies, but FDA offers no guidance for how to write, organize, and maintain SOPs. That means compliance can be difficult—if not downright impossible. 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[URIs: saveastamp.ca] 0.0 T_SPF_HELO_TEMPERROR SPF: test of HELO record failed (temperror) -0.0 SPF_PASS SPF: sender matches SPF record 0.2 HEADER_FROM_DIFFERENT_DOMAINS From and EnvelopeFrom 2nd level mail domains are different 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: 0.5000] 0.0 HTML_MESSAGE BODY: HTML included in message 0.6 KAM_ADVERT2 RAW: This is probably an unwanted commercial email... 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid 0.0 T_DKIM_INVALID DKIM-Signature header exists but is not valid X-Spam-Flag: NO --_=aspNetEmail=_3404afe77ea44731a16c9061e853384e Content-Type: text/plain; charset="UTF-8" Content-Transfer-Encoding: quoted-printable 2018 Update: How to Write Effective SOPs for FDA Inspection and Regulator= y Compliance=0D=0APresented By: Angela Bazigos=0D=0ALive Webinar =0D=0ADa= te: Friday, June 01, 2018 =7C Duration: 90 minutes=0D=0ATime: 1 pm ET =7C= 12 pm CT =7C 11 am MT =7C 10 am PT=0D=0AREGISTER NOW=0D=0ATrain Personne= l on SOPs That Are Consistent =26 Straightforward=0D=0AVirtually every Fo= od and Dr=C3=B9g Administration (FDA) inspection includes a review of sta= ndard operating procedures (SOPs)=2E And adverse ag=C3=A8ncy findings are= often the r=C3=A8sult of SOP administration issues=2E SOPs are required = by law for some companies, but FDA offers no guidance for how to write, o= rganize, and maintain SOPs=2E That means compliance can be difficult=E2=80= =94if not downright impossible=2E=0D=0A=0D=0AJoin regulatory compliance e= xpert Angela Bazigos as she provides the missing guidance on how to draft= effective SOPs and then train personnel to ensure compliance=2E Bazigos = will explain how to establish a set of standards that are concise, reprod= ucible, and=E2=80=94importantly=E2=80=94easy to follow=2E=0D=0A=0D=0AAfte= r attending this audio event, you will know how to create a strategic vie= w of SOPs in your company and how SOPs can help streamline operations and= ensure regulatory compliance=2E You will also understand how to move fro= m regulations to SOPs=2E And you=E2=80=99ll be arm=C3=A8d with best pract= ices to create, implement, and maintain SOPs using a risk-based approach=2E= Never be caught off guard by the FDA again=E2=80=94learn to properly pre= p your SOPs now=2E Read more=0D=0ASession Highlights=0D=0AHere is a taste= of what you will uncover:=0D=0ASOPs and their relation to regulations=0D= =0ASOPs as a part of a company=E2=80=99s regulatory infrastructure=0D=0AS= tandard operating procedures for SOPs=E2=80=94and how to make them concis= e, consistent, and straightforward=0D=0AA risk-based approach to SOP best= practices for creation and maintenance=0D=0ASOP training=0D=0ATools for = SOP tracking and clues to when validation is required=0D=0AWhat the FDA l= ooks for in SOPs during an inspection=0D=0AAnd more=0D=0A CLICK HERE TO = REGISTER =0D=0AGet answers to your questions in the Q=26A directly from = the speaker=0D=0ASav=C3=A8 upto 90=25 with AudioEducator=E2=80=99s Annual= License=0D=0AKnow More=21=0D=0A=E2=9C=86 Call now at 1-866-458-2965 or e= mail at customerservice=40audioeducator=2Ecom (Reference cod=C3=A8: EPHCR= E01_SB)=0D=0AAbout Our Speaker=0D=0AAngela BazigosCEO of Touchstone Techn= ologies Inc=2E She has 40 years of experience in the Life Sciences =26 He= althcare Industries=2E Experience combines Quality Assurance, Regulatory = Compliance, Business Administration, Information Technology, Project Mana= gement, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and = Business Development=2E Read more=0D=0AFollow Us On:=09fb=09tw=09linkedin= =09yt=09Knowledge for Healthcare=0D=0AWe hope you found this message to b= e useful=2E=0D=0AIf you don=E2=80=99t wish to receive any further communi= cation, please click the unsubscribe link below=2E Your request will be p= rocessed within 10 days=2E This is an advertisement=2E =0D=0AAudio Educat= or =7C 2222 Sedwick Rd, Durham NC 27713 =7C 1-866-458-2965 =0D=0AThis mes= sage has been sent by Audio Educator=2E=0A=0A=0AThis message is intended = for JOHN=40TRANSOCEAN=2ECOM=2E If you do not wish to receive future email= s, please click here: http://Incoming=2Esaveastamp=2Eca/unsubstracker=2Ea= spx?=7B0=7D=7BJOHN=40TRANSOCEAN=2ECOM=7D=7B925a64e8-44a1-46e6-9751-aac643= 2e6aa6=7D=2E=0D=0A --_=aspNetEmail=_3404afe77ea44731a16c9061e853384e Content-Type: text/html; charset="UTF-8" Content-Transfer-Encoding: quoted-printable <=21doctype html>=0D=0A=0D=0A=0D=0A=0D=0A2018 Update: How to Write Effective SOPs for FDA Inspection= =26 Regulatory Compliance=0D=0A