Summary:
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
Learning Objectives:
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.
Day 1 Schedule with John E Lincoln
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 2 Schedule with John E Lincoln
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
Meet your Expert:
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.
RAC Credits: 12
Date: October 9th & 10st, 2014
Event Details: http://bit.ly/1lE4ydK
Location: Las Vegas, NV
Venue: Hilton Grand Vacations Suites at the Flamingo
Address: 3575 Las Vegas Boulevard South
Registration: Open Enrollment
Delivery: Face-to-Face event
Until September 20, Early Bird Price: $1,295.00
From September 21 to October 07, Regular Price: $1,495.00
Audience: 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 Web Site: https://www.globalcompliancepanel.com/control/~product_id=900119SEMINAR/DHF-technical-file-design-dossier
Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.
Our Achievements:
Over 300 Experts that are Renowned in their Respective Areas
Successfully Trained more than 20,000 Compliance Professionals
A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth
Having more than 2000 Online Courses
Successfully Completed more than 170 Seminars in US and Globally
Provider:
GlobalCompliancePanel
John Robinson
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Phone: 800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: www.globalcompliancepanel.com
Day 1 Schedule with John E Lincoln