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The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2017

Start Date:
Thursday, 2 March, 2017
End Date:
Friday, 3 March, 2017 6:00pm
Infectious Disease, Emergency Medicine, Pulmonary Medicine, Physical Medicine, Headache / Migraine

Overview:We will consider the following:The Design Control requirements of the CGMPs, 21 CFR 820.30The Design History File - documenting Product Design Control and its nine elementsThe Device Master Record and the Device History RecordThe EU's Medical Device DirectiveThe "Essential Requirements"; and their documentationThe remaining elements of a Technical File / Design DossierTrendsTwo attendee projectsWhy should you attend?This seminar / workshop will examine the existing and proposed requirements for the U.S.

FDA's DHF -- including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, their similarities, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or Notified-Body reviewed; Parallel approaches to development.

Finally, the differing approaches to file audits by the U.S. FDA and the EU Notified Body will be discussed.Who Will Benefit:This workshop will provide valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files / Design Dossiers, documents, activities / plan(s). This information addresses Medical Device documentation requirements and implementation.

The employees who will benefit include:· Senior and middle management and staff· Regulatory Affairs· QA/QC· R&D· Production Management· Manufacturing Engineers· Process Engineers· Project Managers· Vendors, sales and marketing· Any tasked with medical device development, documentation, and regulatory responsibilitiesAgenda:Day 1 ScheduleLecture 1:The Design Control requirements of the CGMPs, 21 CFR 820.30Lecture 2:The Design History File - documenting Product Design Control and its nine elementsLecture 3:The Device Master Record and the Device History RecordLecture 4:Summary of morning discussionLecture 5:Group activity on the 1) The DHF, or 2) The DMR and DHRsLecture 6:Review of group activity and Q&A Day 2 Schedule:Lecture 1:The EU's Medical Device DirectiveLecture 2:The "Essential Requirements" and their documentationLecture 3:The remaining elements of a Technical File / Design DossierLecture 4:ISO 14971:2012, The Product Risk Management File / Report overviewLecture 5:DHF / TF, DD TrendsLecture 6:Summary of morning discussionLecture 7:Group activity on 1) The Technical File / Design Dossier, or 2) Essential RequirementsLecture 8:Review of group activity and Q&ALecture 9:Summary of morning discussionLecture 10:Course summary discussion Speaker: John E LincolnConsultant, Medical device and Regulatory affairs, John E Lincoln is Principal of J.

E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and 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 have been described in peer-reviewed technical articles and workshops worldwide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt. Location: Las Vegas, NV Date: March 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PM Venue: Embassy Suites Convention Center Las Vegas, 3600 Paradise Road, Las Vegas, Nevada, 89169, USA Price:$1,295.00 (Seminar for One Delegate)Register now and save $200. (Early Bird) Until January 20, Early Bird Price: $1,295.00 from January 21 to February 28, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Quick Contact:NetZealous DBA as GlobalCompliancePanelPhone: 1-800-447-9407Fax: Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


Embassy Suites Convention Center Las Vegas 3600 Paradise Road,
Las Vegas,

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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