Net Zealous

USA Seminar 2012 at Pennsylvania

DHF, DMR, DHR and TF - Regulatory Documents Explained, and Best Practices for Controlling Them
by

Jeff Kasoff

On 26th and 27th April, 2012 at Pennsylvania

About GlobalCompliancePanel:
GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of high quality regulatory and compliance-related services. At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances, Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which we have successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of these sessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collective experience are associated with us. Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for group viewing, workshops, live seminars and conferences, onsite trainings and consulting. 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. www.globalcompliancepanel.com All rights are reserved GlobalCompliancePanel.

USA Seminar 2012 at Pennsylvania

Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc

About Speaker:
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Past Seminars

Date and Venue:

April 26th and 27th, 2012 at Pennsylvania Will be announced soon

USA Seminar 2012 at Pennsylvania

Seminar Content:
Conference timings: 9 AM PDT to 5 PM PDT

Why should you attend:

To be in substantial compliance with FDA and ISO regulations, there are many documents that must be maintained by your firm. From the earliest phases of the design process all the way through manufacturing and distribution, all aspects of your plans and records must be documented. As well known as these requirements are, thats the extent to which they are fraught with potential deficiencies. Similarly critical to a compliant document maintenance system is a robust document control system. Without a complete document control system, a company will be out of compliance; without an efficient document control system, a company may be out of business! Dont let your company be that company.
Day 1 - 9th April 2012 Day 2 - 10th April 2012

Lecture 1: Device Master Record

Description DMR Contents

Lecture 5: Document Control

Regulatory History FDA Requirements ISO 13485 Requirements Document Approval Document Control Document Distribution Typical Document Control System Streamlined Document Control Process How to handle "Minor" changes

Lecture 2: DHR - Device History Record

Definition DHR Requirements - Regulation DHR Contents DHR Purpose - Manufacturer DHR Purpose - FDA DHR Requirements, Other

Lecture 6: Document Retention Lecture 3: Design History File

Regulatory Requirements Rationale DHF Contents

Lecture 7: Change Control for Design Documentation

Design History File Risk Assessment

Lecture 4: Technical File

Structure - Outline Structure - Detail Essential Requirements Checklist Risk Analysis

Lecture 8: Other Change Control Considerations

Management Controls Purchasing Controls

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www.globalcompliancepanel.com

USA Seminar 2012 at Pennsylvania

What you get:
1. Learning Objectives 2. Participation certificates 3. Interactive sessions with the US expert 4. 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 professionals

Pricing List:
1. Price for One Delegate pass $1895
(Between March 23th to April 25th)

----------------------------------------2. Early bird price for one Delegate pass $1695

(Between February 16th to March 22th)

Companies that will benefit:

Medical Device companies Start-up and virtual medical device

----------------------------------------3. For discounts on multiple registrations, contact customer care at 1800 447 9407 Professionals who will benefit:
Document Control Personnel R&D Personnel/Management Regulatory Affairs Management

companies

How to Register:
v v v v

Senior Management QA Management Consultants Quality System Auditors Mid-level Management Quality Assurance Professionals

Register online. Use your American Express, Visa or MasterCard For group discount of more than 5 attendees call 800-447-9407 Call +1 - 800-447-9407 or Fax your PO: 302-288-6884 Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL, 6552 Palisades Dr. Centreville, VA 20121

Contact Information:
Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com GlobalCompliancePanel NetZealous 1000 N West Street, Suite 1200, Wilmington, DE 19801..

Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team GlobalCompliancePanel

www.globalcompliancepanel.com

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