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

2-day In-person Seminar:Location : September 12-13, 2013 | Las VegasNet ZealousAbout GlobalCompliancePanel:GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-e f f e c t i v e w h i l e b e i n g c o n v e n i e n t . GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Our services benef i t the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. Profess iona ls who undergo t ra in ings f rom GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till nowBy John E Lincoln, Consultant, Medical device and Regulatory AffairsJohn E. LincolnConsultant, Medical device and Regulatory Affairs 2-day In-person Seminar 2013About Speaker:John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 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. Overview:One of our most popular subjects, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The U.S. FDA's CGMPs mandate Design Control and the Design History File (DHF) at 21 CFR 820.30. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe or Design Dossier, as described in their Medical Device Directive. What are the requirements for each file. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the required content, as well as the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Day 1 - 12th September 2013 Day 2 - 13th September 2013Lecture 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 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 discussionLecture 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 discussionLecture 16: Course summary discussion Course Outline:1. Learning Objectives2. Participation certificates3. Interactive sessions with the US expert4. Post event email assistance to your queries.5. Special price on future purchase of web based trainings.6. Special price on future consulting or expertise services.7. Special price on future seminars by GlobalCompliancePanel. 8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen.9. Networking with industry's top notch professionalsCompanies that will benefit:? Drug and Biologics Companies? PAT Teams? Process DevelopmentProfessionals who will benefit: ? 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 responsibilitiesWhat you get:Pricing List:Price for One Delegate pass Price: $1,295.00Register now and save $200. (Early Bird)Until July 31, Early Bird Price: $1,295.00From August 01 to September 10, Regular Price: $1,495.00September 12-13, 2013 | Las Vegas**Please note the registration will be closed 2days (48 Hours) prior to the date of the seminar.Payment Options:? Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link? Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA? PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884 ? Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer informationContact Information:Event CoordinatorToll free: 1800 447 9407 Fax: 302 288 6884Email: support@globalcompliancepanel.comNetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAKindly get in touch with us for any help or information.Look forward to meeting you at the seminarTeam GlobalCompliancePanel2-day In-person Seminar 2013www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.2-day In-person Seminar 2013www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Registration :FormPlease use this form to register online, using your American Express, Visa or MasterCard.To get discounts on group attendance, please call us on1800 425 9409Call us on 1800 447 9407 or fax your PO to 302 288 6884Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at or email us at Please ?ll this form out and include 100 8425 9409 support@globalcompliancepanel.comattendee and payment details in it and fax it to 302 288 6884Terms and ConditionsYour registration for this seminar is bound by terms and conditions spelt out here. 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Bill me/my company $ ............................................................Purchase order # ........................................................................(Payment is required by the date of the conference.)Please ?ll this form with attendee details and payment details and fax it to 302 288 6884NetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAPhone: 1800 425 9409Toll free (US): 1800 425 9409 / Fax (US): 302 288 6884