Return-Path: <6d04.864a728@vmail40.newsletters.email> Received: from vps.transocean.com by vps.transocean.com with LMTP id UHJtOVTX1FlkIAAAInt2oQ ; Wed, 04 Oct 2017 05:43:00 -0700 Return-path: <6d04.864a728@vmail40.newsletters.email> Envelope-to: JOHN@TRANSOCEAN.COM Delivery-date: Wed, 04 Oct 2017 05:43:00 -0700 Received: from vmail40.newsletters.email ([67.23.183.212]:25212) by vps.transocean.com with esmtp (Exim 4.89) (envelope-from <6d04.864a728@vmail40.newsletters.email>) id 1dzj0g-0002AD-Nm for JOHN@TRANSOCEAN.COM; Wed, 04 Oct 2017 05:43:00 -0700 DKIM-Signature: v=1; a=rsa-sha1; c=simple/simple; d=newsletters.email; s=dknewsletter; t=1507120929; bh=JJRT6GU/Vj3XPBxD5nSqca3/MBU=; h=Date:From:Reply-To:To:Subject:List-Unsubscribe; b=ODl9trMEIsS9K0Z4fFZkfNuW/wWveSxVhA2LnS1vELZ1v1ydWmshMUIeJzCo01ja7 qzdTUCvgI0NgjLcpicz8Xv2hhc0ZDrufBn7PjIdDtuT6ppKZiFKOexa3IOkccKGOvz fmM92D+auRHPpCbcQIUslEaPmCi0C1NCBekIPQpE= Date: Wed, 4 Oct 2017 08:42:09 -0400 From: "FDA Regulations" Reply-To: "FDA Regulations" To: Subject: FDA Laws and Regulations Governing Drugs and Medical Devices Message-ID: <6d04.864a728.1bc1d5e5@vmail40.newsletters.email> X-MNB-TRACKING: Y29kZXJzd2ViIDogSk9ITkBUUkFOU09DRUFOLkNPTSA6IDU5ZDRkNmRjZjQ1MGUzN2RlMDQ1MTM4OA== X-MNB-SENDID: 59d4d6dcf450e37de0451388 List-Unsubscribe: Feedback-ID: 2218794:2207340:newsletter:massmail Content-Type: multipart/alternative; boundary="=_59d4d7211BC1D5E57f39580dd4a07F3940023620864a7286D04" MIME-Version: 1.0 X-Spam-Status: No, score=-1.9 X-Spam-Score: -18 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: FDA Laws and Regulations Governing Drugs, Medical Devices and Combination Products Presented By: Dr. David Lim Live Webinar Date: Tuesday, Oct 10, 2017 | Duration: 60 minutes Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT REGISTER NOW Recent Industry Changes Affecting FDA-regulated Food, Drugs, Cosmetics and Medical Devices Firms operating in an FDA-regulated industry should be well-aware of and understand what laws and regulations apply to FDA-regulated products (e.g., food, drugs, biologics, cosmetics and medical devices including in vitro diagnostics). [...] Content analysis details: (-1.9 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: audioeducator.com] 0.0 HEADER_FROM_DIFFERENT_DOMAINS From and EnvelopeFrom 2nd level mail domains are different 0.0 T_SPF_TEMPERROR SPF: test of record failed (temperror) -0.0 RP_MATCHES_RCVD Envelope sender domain matches handover relay domain -0.0 SPF_HELO_PASS SPF: HELO matches SPF record -1.9 BAYES_00 BODY: Bayes spam probability is 0 to 1% [score: 0.0000] 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.0 HTML_MESSAGE BODY: HTML included in message -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid X-Spam-Flag: NO This is a multi-part message in MIME format. --=_59d4d7211BC1D5E57f39580dd4a07F3940023620864a7286D04 Content-Type: text/plain; charset=UTF-8 Content-Transfer-Encoding: quoted-printable Content-Disposition: inline FDA Laws and Regulations Governing Drugs, Medical Devices and Combination P= roducts Presented By: Dr. David Lim Live Webinar Date: Tuesday, Oct 10, 2017 | Duration: 60 minutes Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT REGISTER NOW Recent Industry Changes Affecting FDA-regulated Food, Drugs, Cosmetics and = Medical Devices Firms operating in an FDA-regulated industry should be well-aware of and un= derstand what laws and regulations apply to FDA-regulated products (e.g., f= ood, drugs, biologics, cosmetics and medical devices including in vitro dia= gnostics). This session by expert speaker Dr. David Lim, will help you learn the laws = and regulations governing food, drugs, biologics, cosmetics, combination pr= oducts and medical devices including in vitro diagnostic medical devices (I= VDs). David will share key statutory and regulatory requirements as set out= in the laws and regulations and will provide an overview of recent changes= and amendments to important FDA regulations. Domestic and foreign firms, w= ho are involved in either directly or indirectly handling medical products = (food, drugs, cosmetics, combination products, medical devices and IVDs) wi= ll become aware of the regulations that impact these products. Read more Session Highlights Overview of laws and regulations including recent amendments Definitions Statutory requirements Good manufacturing practices for food, drugs, biologics, and devices includ= ing IVDs Regulatory requirements Investigational new dr=C3=B9g application (IND) and investigational device = exemption (IDE) Differences between cosmetics and medical devices Common non-compliance issues and consequences FDA enforcement actions: recent cases Best practices: dos and don=E2=80=99ts PASS-IT suggestions and recommendations And more Apply "PM20" at check-out to get $20 off on registration CLICK HERE TO REGISTER =20 Get answers to your questions in the Q&A directly from the speaker For Spec=C3=ACal Offers, Deals & Discounts: =E2=9C=86 Call now at 1-866-458-2965 or email at customerservice@audioeduca= tor.com (Reference cod=C3=A8: EFOOJC02_MB) To join our mailing list and receive invitations to similar webinars, click= here. About Our Speaker Dr. David LimDr. David Lim, Ph.D., RAC, ASQ-CQA is president and principal = of Regulatory Doct=C3=B2r (www.RegulatoryDoct=C3=B2r.us). Dr. Lim is a lead= ing industry speaker and frequently presents global regulatory and quality = compliance topics in various forums and meetings. Read more Follow Us On: fb tw linkedin yt Knowledge for Healthcare We hope you found this message to be useful. If you don=E2=80=99t wish to receive any further communication, please clic= k the unsubscribe link below. Your request will be processed within 10 days= .=20 This message has been sent by Audio Educator. Audio Educator - 2222 Sedwick Rd - Durham - NC - 27713 Subscribe to this newsletter: https://www.newsletters.email/tools/subscription.php?username=3Dcodersweb&s= end_id=3D59d4d6dcf450e37de0451388&l=3Ds&newsletter_id=3D1413173980 Unsubscribe JOHN@TRANSOCEAN.COM: https://www.newsletters.email/tools/subscription.php?username=3Dcodersweb&s= end_id=3D59d4d6dcf450e37de0451388&l=3Du&email=3DJOHN@TRANSOCEAN.COM Change your preferences: https://www.newsletters.email/tools/subscription.php?username=3Dcodersweb&s= end_id=3D59d4d6dcf450e37de0451388&l=3Dp&email=3DJOHN@TRANSOCEAN.COM Forward to a friend: https://www.newsletters.email/tools/forward.php?username=3Dcodersweb&newsle= tter_id=3D1413173980&send_id=3D59d4d6dcf450e37de0451388 Report this email as spam: https://www.newsletters.email/tools/abuse_report.php?username=3Dcodersweb&s= end_id=3D59d4d6dcf450e37de0451388&email=3DJOHN@TRANSOCEAN.COM This email was sent using MyNewsletterBuilder.com. --=_59d4d7211BC1D5E57f39580dd4a07F3940023620864a7286D04 Content-Type: text/html; charset=UTF-8 Content-Transfer-Encoding: quoted-printable Content-Disposition: inline
FDA Laws and Regulations Governi= ng Drugs, Medical Devices and Combination Products
Presented By: Dr. David Lim
Live Webinar Date: Tuesday, Oct 10, 2017 | Duration: 60 minutes
Time: 1 pm ET | 12 pm CT | 11 am MT |= 10 am PT
REGISTER NOW
Recent Industry Changes Affecting FDA-regulated Food, Drugs, = Cosmetics and Medical Devices
Firms operating in an FDA-regulated industry shoul= d be well-aware of and understand what laws and regulations apply to FDA-re= gulated products (e.g., food, drugs, biologics, cosmetics and medical devic= es including in vitro diagnostics).

This session by expert spea= ker Dr. David Lim, will help you learn the laws and regula= tions governing food, drugs, biologics, cosmetics, combination products and= medical devices including in vitro diagnostic medical devices (IVDs). Davi= d will share key statutory and regulatory requirements as set out in the la= ws and regulations and will provide an overview of recent changes and amend= ments to important FDA regulations. Domestic and foreign firms, who are inv= olved in either directly or indirectly handling medical products (food, dru= gs, cosmetics, combination products, medical devices and IVDs) will become = aware of the regulations that impact these products. Read mo= re
Session Highlights
  • Overview of laws an= d regulations including recent amendments
  • Definitions<= /li>
  • Statutory requireme= nts
  • Good manufacturing = practices for food, drugs, biologics, and devices including IVDs
  • Regulatory requirem= ents
  • Investigational new= drùg application (IND) and investigational device exemption (IDE)
  • Differences between= cosmetics and medical devices
  • Common non-complian= ce issues and consequences
  • FDA enforcement act= ions: recent cases
  • Best practices: dos= and don’ts
  • PASS-IT suggestions= and recommendations
  • And more
Apply "PM20" at check-out to get $20 off o= n registration
  CLICK HERE TO REGISTER  
Get answers to your questions in the Q&= ;A directly from the speaker
For Specìal Offer= s, Deals & Discounts:
=E2=9C=86 Call now at 1-86= 6-458-2965 or email at customerser= vice@audioeducator.com (Reference codè: EFOOJC02_MB)
To join our mailing = list and receive invitations to similar webinars, click here.
About Our Speaker
3D"Dr. Dr. David Lim, Ph.D., RAC, A= SQ-CQA is president and principal of Regulatory Doctòr (www= .RegulatoryDoctòr.us). Dr. Lim is a leading industry speaker and fre= quently presents global regulatory and quality compliance topics in various= forums and meetings. Read more
Follow Us On: 3D"fb" 3D"tw" =3D"linkedin" 3D"Knowl=
 
W= e hope you found this message to be useful.
If you don’t wish to= receive any further communication, please click the unsubscribe link below= . Your request will be processed within 10 days. 
This message h= as been sent by Audio Educator.
3D"Please

Audio Educator  •  2222 = Sedwick Rd  •  Durham, NC 27713

http://www.audioeducato= r.com
Subscribe  •&nb= sp; Prefe= rences  •  Send to a Friend  •  Unsubscribe  •  Report Spam
Powered by MyNewsletter= Builder
3D"Please
3D"Please
3D"Share 3D"Bookmark  
--=_59d4d7211BC1D5E57f39580dd4a07F3940023620864a7286D04--