Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id cMrqFjuFy1puagAAInt2oQ for ; Mon, 09 Apr 2018 08:22:35 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Mon, 09 Apr 2018 08:22:35 -0700 Received: from mta034b.pmx1.epsl1.com ([142.54.244.34]:45063) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f5Ycf-00076B-S3 for charley@transocean.com; Mon, 09 Apr 2018 08:22:35 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=simple/simple; d=info.complianceonline.com; s=ep1; t=1523286093; bh=dHdVWJv7ZwSFb1OBeAS5E/UooJXh0ilni1jE82u0wjs=; h=MIME-Version:Subject:From:To:Date:Content-Type; b=AEfFkshpGajXlfKbjGt6K5rbciLcYRf30Zfrf9b9oYROqYr9VN5RhzCesQnsMe3jD 6x5JmXghjYTA6nQOC/bRBQ1pl6ZSqZvs2ucaGudOgRYcjzE58THRfWRzh8LO0bHFji 4gJcuvhrooGCurmLghG2QDlRpvgZaRJeCgFDRJOg= Received: from [10.233.18.114] ([10.233.18.114:34524]) by pc1udsmtn1n18 (envelope-from ) (ecelerity 3.6.9.48312 r(Core:3.6.9.0)) with ECSTREAM id 6B/03-22713-D408BCA5; Mon, 09 Apr 2018 15:01:33 +0000 List-Unsubscribe: Message-ID: MIME-Version: 1.0 Reply-To: "training@info.complianceonline.com" Subject: Designing and Sustaining New & Existing Product Stability Testing Program From: compliance seminar To: charley@transocean.com Date: Mon, 9 Apr 2018 15:01:33 +0000 Content-Type: multipart/alternative; boundary="-=Part.3646256.831ae8274db87d7d.162aaed2ced.d117b4e06d629526=-" X-Spam-Status: No, score=2.2 X-Spam-Score: 22 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 Designing and Sustaining New and Existing Product Stability Testing Program 2-Day In-Person Seminar Orlando, FL -- June 07-08, 2018 • View Agenda Speaker: Charity Ogunsanya, CEO and Founder, Pharmabiodevice Consulting LLC This seminar will help the attendee gain a better understanding of the requirements of the FDA's Drug Stability Guidelines that is stipulated for new, existing and modified drug products that have an existing or new IND or NDA submission. [...] Content analysis details: (2.2 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. [URIs: complianceonline.com] -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.8 MPART_ALT_DIFF BODY: HTML and text parts are different 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4569] -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 MIME_HTML_ONLY_MULTI Multipart message only has text/html MIME parts X-Spam-Flag: NO ---=Part.3646256.831ae8274db87d7d.162aaed2ced.d117b4e06d629526=- Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset=UTF-8 ComplianceOnline
Comp= lianceOnline
The Largest GRC Ad= visory Network 		+1-888-717-24= 36
Designing and= Sustaining New and Existing Product Stability Testing Program 2-Day In-Pe= rson Seminar
Orlando, FL -- = June 07-08, 2018 =E2=80=A2 View Agenda
<= strong>Speaker: Charity Ogunsanya, CEO and Founde= r, Pharmabiodevice Consulting LLC
This seminar will help the attendee gain a better understanding o= f the requirements of the FDA's Drug Stability Guidelines that is stipulate= d for new, existing and modified drug products that have an existing or new= IND or NDA submission=2E

This seminar will also benefit peop= le within the Pharmaceutical, Biotechnology or Medical Device industries th= at are currently have a stability testing program but do not know how to ma= ximize the use of their data for extending their product's expiration datin= g=2E

This seminar will provide the detailed requirements appl= icable to the FDA's and 21CFR 514=2E1(b)(5)(x) expectations which states th= at "an applicant should submit data from stability studies that have been c= ompleted as well as information about studies that are underway to substant= iate the request for a specific expiration date and provide information on = the stability of the drug products" FDA's Guidance for Industry=2E For this= reason, it is important to have clarity and understanding of how to apply = this regulation prior to the initiation of a new product stability testing = program which includes the protocol design, testing, storage, data manageme= nt, trending and expiration dating extrapolations and expectations for prod= ucts in a new or existing IND or NDA application process=2E

Register Now
Speaker Profile:

Ms=2E Ogunsanya has over 23 years of extensive practical and management experience in= various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy= , diagnostics, research and development, radio-pharmaceutical, Contract Man= ufacturing Organization (CMO) and medical device/IVD companies=2E
View Details
4th Annual Medical Device Summit 2018 | San Franci= sco, CA | June 7-8, 2018
=C2=A9 Copyright 2018 | 2479 East Bayshore Road, Suite 200 = Palo Alto, CA 94303, USA | +1-888-717-2436
This message was sent to charley@transocean=2Ecom | Unsubscribe=2E
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