DHF, DMR, DHR, TECHNICAL FILE AND DESIGN DOSSIER – KEY REQUIREMENTS AND FUTURE DIRECTIONS
August 28 - 29, 2014 - San Francisco CA USGlobalCompliancePanel
support@globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
Overview: We will consider the following: • The Design Control requirements of the CGMPs, 21 CFR 820.30 • The Design History File - documenting Product Design Control and its nine elements • The Device Master Record and the Device History Record • The EU’s Medical Device Directive • The "Essential Requirements"; and their documentation • The remaining elements of a Technical File / Design Dossier • Trends • Two attendee projects Why 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 responsibilities Course Outline/Agenda: Day One Lecture 1: The Design Control requirements of the CGMPs, 21 CFR 820.30 Lecture 2: The Design History File - documenting Product Design Control and its nine elements Lecture 3: The Device Master Record and the Device History Record Lecture 4: Summary of morning discussion Lecture 5: Group activity on the 1) The DHF, or 2) The DMR and DHRs Lecture 6: Review of group activity and Q&A Day Two Lecture 7: The EU's Medical Device Directive Lecture 8: The "Essential Requirements" and their documentation Lecture 9: The remaining elements of a Technical File / Design Dossier Lecture 10: ISO 14971:2012, The Product Risk Management File / Report overview Lecture 11: DHF / TF, DD Trends Lecture 12: Summary of morning discussion Lecture 13: Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements Lecture 14: Review of group activity and Q&A Lecture 15: Summary of morning discussion Lecture 16: Course summary discussion Instructor/Speaker Profile: John E Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, 17 of which as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment V&V including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on V &V, CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, root cause analysis, and others. John is a graduate of UCLA. Date, Venue and Price: Location: Las Vegas, NV Date: August 28th & 29th, 2014 Time: 9:00 AM to 6:30 PM Venue/Hotel: Hilton Grand Vacations Suites at the Flamingo Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USA Price: $1295.00 (Seminar for One Delegate) Discount: Register now and save $200. (Early Bird) Until July 15, Early Bird Price: $1,295.00, From July 16 to August 26, Regular Price: $1,495.00 Want to register by Wire Transfer? Please call any of our representatives on 1800 447 9407 to help you completed the transfer. Contact Information: John Robinson Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Live Chat - Online Help Desk: http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA For More Info on This Seminar Kindly Go through the Below Link: http://bit.ly/1mKTZj4 To Download Seminar Boucher: http://bit.ly/1mKU9Xs GlobalCompliancePanel Seminar Gallery: http://bit.ly/1mCjvMb