Conference about Drafting a Software V&V Documentation Package and Protocol
View: 222
Website http://bit.ly/Drafting_a_Software |
Edit Freely
Category industry software validation models, models in banking plans software, planning for system security
Deadline: May 24, 2016 | Date: May 25, 2016
Venue/Country: Online Event, U.S.A
Updated: 2016-04-12 19:09:18 (GMT+9)
Call For Papers - CFP
Overview: The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA.This webinar will address the use of the FDA, DAMP, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be realistly accomplished. This webinar will address software that is:As-Product;In-Product;In Production and Test Equipment; andThe Quality System.A manufacturer is responsible to identify these requirements and implement them into an effective software V&V process. Areas Covered in the Session:Verification or ValidationCurrent Regulatory Expectations and “Hot Buttons”The Project Validation PlanProduct and Process / Equipment Software V&VWhen and How to Use DQ, IQ, OQ, PQGAMP ConsiderationsThe FDA's 11 Key Elements"White Box" and "Black Box" ValidationsWho Will Benefit:Senior management, Project Leaders, Internal / External consultantsMid-level Management and Supervisory PersonnelRegulatory AffairsQuality Systems Personnel / QAER&D and Engineering StaffNew Product Development PersonnelValidation TechniciansIT DepartmentMedical Device, Equipment / Process SW ProgrammersSpeaker Profile: John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.comhttp://www.compliance4all.com/Event Link : http://bit.ly/Drafting_a_SoftwareLinkedIn Like us – https://www.linkedin.com/company/compliance4allTwitter Follow us – https://twitter.com/compliance4allFacebook Like us – https://www.facebook.com/Compliance4all
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.