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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: View Online Live Webinar Verification vs Validation-Product, Process or Equipment and QMS Software REGISTER NOW! The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world". Date: Tuesday, April 10, 2018 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: John E Lincoln Overview: The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations. Read more... Who Will Benefit: Senior Management in Drugs, Devices, Combination Products, Biologics, Dietary Supplements QA / RA Software Development, Programming, Documentation, Testing teams R&D Engineering Production Operations Consultants,Others tasked with product,Process,Electronic records software V&V responsibilities About Speaker: John E Lincoln Consultant, Medical device and Regulatory affairs John E. Lincoln, is a medical device and rewgulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses... Read More Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Toll Free: +1-800-447-9407 Fax: 302 288 6884 www.compliance4all.com | Unsubscribe Copyright © 2017 compliance4All. All rights reserved. [...] Content analysis details: (2.4 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- -0.0 RCVD_IN_MSPIKE_H2 RBL: Average reputation (+2) [129.145.68.202 listed in wl.mailspike.net] 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: compliance4all.com] -0.0 SPF_PASS SPF: sender matches SPF record -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 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 -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 1.0 FROM_EXCESS_BASE64 From: base64 encoded unnecessarily X-Spam-Flag: NO <=21DOCTYPE html PUBLIC =22-//W3C//DTD XHTML 1=2E0 Transitional//EN=22 =22h= ttp://www=2Ew3=2Eorg/TR/xhtml1/DTD/xhtml1-transitional=2Edtd=22> <=21--=5Bif gte mso 9=5D> <=21=5Bendif=5D--><=21--=5Bif = mso=5D> <=21=5Bendif=5D-->
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3D=22Logo=22=
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Live Webinar
Verification vs Validation-Product, Process or Equipment and Q= MS Software
REGISTER NOW=21
The FDA and other regulatory agencies have stated that soft= ware validation can only be accomplished effectively if =22risk-based=22=2E= How can this be done in the =22real world=22=2E
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Date: Tuesday, April 10, 2018
Time: 10:00 AM PDT = =7C 01:00 PM EDT
Duration: 90 Minutes<= br /> Instructor: John E Li= ncoln
Overview:
The verification and validation of regulated= software is coming under increased scruinty by the U=2ES=2E FDA=2EThis web= inar will address the use of the FDA, GAMP, 21 CFR Part 11,=22Electronic Re= cords=22/=22Electronic Signatures=22, IEC 62304, and other applicable indus= try software validation models, coupled with the ISO 14971/ICH Q9 Product R= isk Management models, to plan, structure, run, and document acceptable sof= tware validations=2E = Read more=2E=2E=2E
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Who Will Bene= fit:
  • Senio= r Management in Drugs, Devices, Combination Products, Biologics, Dietary Su= pplements
  • QA / = RA
  • Softw= are Development, Programming, Documentation, Testing teams
  • R&D
  • Engin= eering
  • Produ= ction
  • Opera= tions
  • Consu= ltants,Others tasked with product,Process,Electronic records software V&V r= esponsibilities
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=
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About Speaker= :
John E Linco= ln
Consultant, = Medical device and Regulatory affairs
John= E=2E Lincoln, is a medical device and rewgulatory affairs consult= ant=2E He has helped companies to implement or modify their GMP systems and= procedures, product risk management, U=2ES=2E FDA responses=2E=2E=2E Read More
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Compliance4All
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA= =2E
Tol= l Free: +1-800-447-9407
Fax: 302 288 6884
www=2Ecompliance4all=2Ecom =7C=  Unsubscribe
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Copyright © 2017 compliance4All=2E = All rights reserved=2E
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