Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id +O8WJMoXxVpNXgAAInt2oQ for ; Wed, 04 Apr 2018 11:22:02 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Wed, 04 Apr 2018 11:22:02 -0700 Received: from mta1.globalcompliancepanel.com ([54.38.142.91]:44159) by vps.transocean.com with esmtps (TLSv1.2:ECDHE-RSA-AES256-GCM-SHA384:256) (Exim 4.89_1) (envelope-from ) id 1f3n2f-0006GJ-EP for charley@transocean.com; Wed, 04 Apr 2018 11:22:02 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; d=globalcompliancepanel.com; q=dns/txt; s=sarvtes; bh=YpCMpFwhKdUOpEuu/lK9eZWJRh/mCctkg7nRIj44MX4=; h=from:reply-to:subject:to:mime-version:content-type:list-unsubscribe; b=voVT80QwrzfS2o/zwTlSZX/u+ln4R3FhfoDKoo5pOkt9c5GhIEB/6wVt7gE3RAPgJUbxaEb+P UWMZzaxfg1+yKpPuuh2nhG4e+p+dVtSi7TOFyXPB+Dn3g1iAaWcIPmF6lrTB0PtQgbj+E1usCvC eT4i6bzNrgfYexuvBNVgSdM= Content-Type: multipart/alternative; boundary="_----------=_MCPart_243900833" X-Unique-Id: 6f704109836ce7d232147ab8632d96fe19425c2748b410c9b4432a1d25aaed31d0a6ee8f5862238e1c547c8d67cf6333d86c2652c66b15474766b6f3fb8ae739fded6c81fa44fabb0a46cc15e72c015d0136c28035a364b7176f694b60bac9abad03e693f0004464662c49a34c489ebf4b885b657b8b0d387ec07b92b2a7460d Precedence: bulk X-Feedback-Id: 43998901:5ac47de91f2b1d53768b458b.5ac47f1724696fd201abacc5:app:mg List-Unsubscribe: , Reply-To: inpersonseminar@globalcompliancepanel.com From: Phase I Clinical Studies Under GMP To: charley@transocean.com Subject: Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result? Message-Id: <1522865995737-0247dd98-d7726e17-03ea3055@globalcompliancepanel.com> Date: Wed, 04 Apr 2018 18:19:55 +0000 MIME-Version: 1.0 X-Mta-Unique-Id: sttkRnRq.pkbpppeR--71279470-2B847ABF-CB16-4B26-9651-1EDAE8618957.4.1 Received: from (127.0.0.1) by mta1.globalcompliancepanel.com id 2B847ABF-CB16-4B26-9651-1EDAE8618957.4 for ; Wed, 04 Apr 2018 18:21:10 +0000 (envelope-from ) X-Spam-Status: No, score=0.9 X-Spam-Score: 9 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: Different requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result? About Us Webinars($10) SeminarsPast Seminar Pictures Use MGCP50 Promo Code to GET FLAT 50% OFF on ALL SEMINARS - Offer Ends Today 2-day In-person SeminarDifferent requirements for Phase I Investigational Drug Products: which GMPs apply since most Phase I drugs are exempt from full GMP requirements and what IND data requirements are necessary as a result? Click Here for More Details! Overview: In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). Read more... Date & Time Date: May 10th & 11th, 2018 Time: 9:00 AM to 6:00 PMDownload Seminar Brochure VenueSalt Lake City, UT Hilton Garden Inn Salt Lake City AirportDownload Registration form Stephanie Cooke President/CEO, Cooke Consulting Inc.Stephanie Cooke, is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms. Reserve your Seat Now Enroll Now! Copyright © 2016 GlobalCompliancePanel. All Rights Reserved. . 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[URIs: globalcompliancepanel.com] -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] 0.2 KAM_TRACKIMAGE RAW: Message has a remote image explicitly meant for tracking -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 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid 0.0 MSGID_FROM_MTA_HEADER Message-Id was added by a relay X-Spam-Flag: NO --_----------=_MCPart_243900833 Content-Type: text/plain; charset=utf-8 Content-Transfer-Encoding: quoted-printable Different requirements for Phase I Investigational Drug Products: which = GMPs apply since most Phase I drugs are exempt from full GMP requirements = and what IND data requirements are necessary as a result? About Us Webinars($10) SeminarsPast Seminar Pictures=20 Use MGCP50 Promo Code to GET FLAT 50% OFF on ALL SEMINARS - Offer Ends = Today 2-day In-person SeminarDifferent requirements for Phase I Investigational = Drug Products: which GMPs apply since most Phase I drugs are exempt from = full GMP requirements and what IND data requirements are necessary as a = result? Click Here for More Details! Overview: In January 2006, FDA issued a final rule which specified that = most pharmaceutical products (including biologics) produced for use in = Phase I clinical trial studies were exempted from complying with GMP = requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section = 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to = comply with cGMPs or if they are not manufactured in compliance with cGMPs,= they are deemed adulterated. Based on this statutory requirement for = manufacturers to follow GMPs, FDA issued cGMP regulations for drug and = biological products in the Code of Federal Regulations (in 21 CFR parts 210= and 211). Read more...=20 Date & Time Date: May 10th & 11th, 2018 Time: 9:00 AM to 6:00 PMDownload Seminar Brochure=20 VenueSalt Lake City, UT=20 Hilton Garden Inn Salt Lake City AirportDownload Registration form Stephanie Cooke=20 President/CEO, Cooke Consulting Inc.Stephanie Cooke, is the President/CEO = of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience= to provide global consulting services in various areas of Regulatory = Affairs, Quality Assurance and validation for pharmaceutical, = biological/biotech products, medical device, combination drug/device and = nutraceutical firms.=20 Reserve your Seat Now=20 Enroll Now! Copyright =C2=A9 2016 GlobalCompliancePanel. All Rights Reserved.=20 . --_----------=_MCPart_243900833 Content-Type: text/html Content-Transfer-Encoding: quoted-printable
 
 
 
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About Us We= binars($10) Seminars
Past Seminar Pictures
 
 
 
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  Use MGCP50 Promo Code to GET FLAT 50% OFF on ALL = SEMINARS - Offer Ends = Today  
 
 
2-day In-person Seminar
Different requirements for Phase I Investigational Drug = Products: which GMPs apply since most Phase I drugs are exempt from full = GMP requirements and what IND data requirements are necessary as a result? =
Click Here for More Details!
 
 
3D"bottom
 
 
Overview: In January 2006, FDA issued a final rule = which specified that most pharmaceutical products (including biologics) = produced for use in Phase I clinical trial studies were exempted from = complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR= 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, = including IND products, to comply with cGMPs or if they are not = manufactured in compliance with cGMPs, they are deemed adulterated. Based = on this statutory requirement for manufacturers to follow GMPs, FDA issued = cGMP regulations for drug and biological products in the Code of Federal = Regulations (in 21 CFR parts 210 and 211). Read more...
 
 
 
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Date & Time
Date: May 10th = & 11th, 2018
Time: 9:00 AM to 6:00 PM
Download Seminar Brochure
 
Venue
Salt Lake City, UT
Hilton Garden Inn Salt Lake City Airport
Download Registration form
 
 
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Stephanie Cooke
Presid= ent/CEO, Cooke Consulting Inc.
Stephanie Cooke, is the President/CEO of = Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to= provide global consulting services in various areas of Regulatory Affairs,= Quality Assurance and validation for pharmaceutical, biological/biotech = products, medical device, combination drug/device and nutraceutical firms. =
 
 
3D"top
 
 
Reserve your Seat Now
 
 
Enroll Now!
 
 
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Copyright © = 2016 GlobalCompliancePanel. All Rights Reserved.
 
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