Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id oC//IXqT2FpoJAAAInt2oQ for ; Thu, 19 Apr 2018 06:02:50 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Thu, 19 Apr 2018 06:02:50 -0700 Received: from ccm38.constantcontact.com ([208.75.123.163]:38871) by vps.transocean.com with esmtps (TLSv1.2:ECDHE-RSA-AES256-GCM-SHA384:256) (Exim 4.89_1) (envelope-from ) id 1f99Co-0002TT-BU for louk@transocean.com; Thu, 19 Apr 2018 06:02:50 -0700 Received: from [10.252.1.141] ([10.252.1.141:42756] helo=p2-jbsvcs5293.ad.prodcc.net) by 10.249.247.24 (envelope-from ) (ecelerity 4.2.1.52273 r(Core:4.2.1.11)) with ESMTP id FE/55-42292-D3398DA5; Thu, 19 Apr 2018 09:01:49 -0400 DKIM-Signature: v=1; q=dns/txt; a=rsa-sha256; c=relaxed/relaxed; s=1000073432; d=auth.ccsend.com; h=date:mime-version:subject:X-Feedback-ID:message-id:from:reply-to:list-unsubscribe:list-unsubscribe-post:to; bh=dbLI7TcFx3qMUXLA1lLQBfAgnpqer+4SX7gRuENZRXs=; b=i/1wJG0Vp7cAL0P7qNmFgUKWkpNaSWnk2Q/LZQ3row4OwMwLu0BP064BBM3dzH3OdyITsJfc22vERWYxGVv+xaj664ho3+tbWaBOAk4e3hxzTy+mVvLS6Ikv9MkMXYUUlOoUtwBuj1TT7WYYSfH5MeT2NbUcKD0XSzEEXTlVWjg= Message-ID: <1130439630612.1130093494344.1598754893.0.400900JL.1002@scheduler.constantcontact.com> Date: Thu, 19 Apr 2018 09:01:49 -0400 (EDT) From: Danielle DeLucy Reply-To: info@ustrainings.com To: louk@transocean.com Subject: A Webinar On Annual Product Review MIME-Version: 1.0 Content-Type: multipart/alternative; boundary="----=_Part_471874750_1373038745.1524142909422" List-Unsubscribe: List-Unsubscribe-Post: List-Unsubscribe=One-Click X-Campaign-Activity-ID: 9d8c183e-3aba-4eb4-81f7-ef689eece2ea X-Channel-ID: e24e8210-430a-11e8-b6fd-d4ae52754007 X-Mailer: Roving Constant Contact 2012 (http://www.constantcontact.com) X-Return-Path-Hint: AnYwYPjq6TrSB9+9onuzi6g==_1130093494344_4k6CEEMKEei2/dSuUnVABw==@in.constantcontact.com X-Roving-Campaignid: 1130439630612 X-Roving-Id: 1130093494344.1598754893 X-Feedback-ID: e24e8210-430a-11e8-b6fd-d4ae52754007:9d8c183e-3aba-4eb4-81f7-ef689eece2ea:1130093494344:CTCT X-CTCT-ID: e0e3f590-430a-11e8-b6e2-d4ae52754007 X-Spam-Status: No, score=-5.2 X-Spam-Score: -51 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: Proper Execution of Annual Product Review Proper Execution of Annual Product Review Introduction  Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product. Register Now Learning Objectives Discuss how to write APRs Outline the requirements for APR reporting Review what information to include in the reports Discuss how well written APRs benefit your firm’s compliance Read More... Who Will Benefit ? Quality Assurance Quality Control Directors Managers Specialists Regulatory Affairs Regulatory Compliance Directors Read More... Tuesday,May 1st, 2018  01:00 PM EST 10:00 AM PST 60 Mins. Webinar SPEAKER PROFILE: Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality Why should you attend? This webinar will discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product. Read More... Areas covered in the webinar Annual Product Review definition What needs to be included in the report A model of an example Annual Product Review Report Review of citations Read More... Register Now ‌ N/A | 230 Truxtun Ave, 5th floor, Bakersfield, CA 93301 Unsubscribe louk@transocean.com Update Profile | About [...] Content analysis details: (-5.2 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. 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It is designed to minimize the product defects and also the risks a= ssociated with the manufacturing of the pharmaceutical product. Register No= w Learning Objectives Discuss how to write APRs Outline the requirements fo= r APR reporting Review what information to include in the reports Discuss h= ow well written APRs benefit your firm=E2=80=99s compliance Read More... Wh= o Will Benefit ? Quality Assurance Quality Control Directors Managers Speci= alists Regulatory Affairs Regulatory Compliance Directors Read More... Tues= day,May 1st, 2018 =EF=BB=BF 01:00 PM EST 10:00 AM PST 60 Mins. Webi= nar SPEAKER PROFILE: Danielle DeLucy, MS, is owner of ASA Training and Cons= ulting, LLC which provides Pharmaceutical and Biologics based companies wit= h training and quality systems assistance in order to meet Regulatory compl= iance. Prior to this role, Danielle has been in the industry for 15 years s= erving in numerous Quality Management Roles, such as the Director of Produc= t Quality Why should you attend? This webinar will discuss the comparative = evaluation about similarities and differences of requirements associated wi= th the manufacturing of the drug product in different countries. It is also= necessary to know that the regulatory requirements of different countries = are different and hence this will further guarantee the quality of the phar= maceutical product. Read More... Areas covered in the webinar Annual Produc= t Review definition What needs to be included in the report A model of an e= xample Annual Product Review Report Review of citations Read More... Regist= er Now =E2=80=8C N/A | 230 Truxtun Ave, 5th floor, Bakersfield, CA 93301 Un= subscribe louk@transocean.com Update Profile | About our service provider S= ent by info@ustrainings.com in collaboration with Try it free today ------=_Part_471874750_1373038745.1524142909422 Content-Type: text/html; charset=utf-8 Content-Transfer-Encoding: quoted-printable
Proper Execution of Annual Product Revi= ew
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Proper Execution of = Annual Product Review

Annual Product Qua= lity Review (APR) is an evaluation conducted annually to determine if there= are any possible changes in the process or manufacturing of the pharmaceut= ical product or any change in the specifications of the product or any chan= ge in the manufacturing process. It is designed to minimize the product def= ects and also the risks associated with the manufacturing of the pharmaceut= ical product.
  • Quality Assurance
  • Quality Control Directors
  • Managers
  • Specialists Regulatory Affairs
  • Regulatory Compliance Directors
Tuesday,May = 1st, 
=    2018  
&= #xfeff;
01:00 PM EST 
10:00 AM PST 
60 Mins. Webinar
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Danielle DeLucy, MS, is owner of ASA T= raining and Consulting, LLC which provides Pharmaceutical and Biologics bas= ed companies with training and quality systems assistance in order to meet = Regulatory compliance. Prior to this role, Danielle has been in the industr= y for 15 years serving in numerous Quality Management Roles, such as the Di= rector of Product Quality
This webinar will discuss the comparative evaluation about s= imilarities and differences of requirements associated with the manufacturi= ng of the drug product in different countries. It is also necessary to know= that the regulatory requirements of different countries are different and = hence this will further guarantee the quality of the pharmaceutical product= .
Areas covered in the webinar

  • Annual Product Review definition
  • What needs to be included in th= e report
  • A model of an = example Annual Product Review Report
  • Review of citations


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=20 N/A | 230 Truxtun A= ve, 5th floor, Bakersfield= , CA 93301 =20
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Update Profile | About our service provider
Sent by =20 info@ustrainings.com =20 =20 =20 in collaboration wi= th =20 =20
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