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 Š 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, that’s 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! Don’t let your company be that company. Day 1 - 9th April 2012
Day 2 - 10th April 2012
Lecture 1: Device Master Record
Lecture 5: Document Control
„ Description
„
Regulatory History
„ DMR Contents
„
FDA Requirements
„
ISO 13485 Requirements
„
Document Approval
Lecture 2: DHR - Device History Record „
Definition
„
Document Control
„
DHR Requirements - Regulation
„
Document Distribution
„
DHR Contents
„
Typical Document Control System
„
DHR Purpose - Manufacturer
„
Streamlined Document Control Process
„
DHR Purpose - FDA
„
How to handle "Minor" changes
„
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 Lecture 8: Other Change Control Considerations
„
Structure - Outline
„
Structure - Detail
„
Essential Requirements Checklist
„
Management Controls
„
Risk Analysis
„
Purchasing Controls
www.globalcompliancepanel.com
All rights are reserved © GlobalCompliancePanel.
USA Seminar 2012 at Pennsylvania What you get:
Pricing List:
1. Learning Objectives
1. Price for One Delegate pass $1895
2. Participation certificates 3. Interactive sessions with the US expert
(Between March 23th to April 25th)
4. Post event email assistance to your queries.
----------------------------------------2. Early bird price for one Delegate pass $1695
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,
(Between February 16th to March 22th)
----------------------------------------3. For discounts on multiple registrations, contact customer care at 1800 447 9407
notepad and pen. 9. Networking with industry's top notch professionals
Companies that will benefit: —Medical Device companies —Start-up and virtual medical device
Professionals who will benefit:
companies
£ Document Control Personnel £ R&D Personnel/Management £ Regulatory Affairs Management
How to Register:
£ Senior Management
v
Register online. Use your American Express, Visa or MasterCard
£ QA Management
v
For group discount of more than 5 attendees call 800-447-9407
£ Consultants
v
Call +1 - 800-447-9407 or Fax your PO: 302-288-6884
v
Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL, 6552 Palisades Dr. Centreville, VA 20121
£ Quality System Auditors £ Mid-level Management £ Quality Assurance Professionals
Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com GlobalCompliancePanel NetZealous 1000 N West Street,
Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team GlobalCompliancePanel
Suite 1200, Wilmington, DE 19801..
www.globalcompliancepanel.com
All rights are reserved © GlobalCompliancePanel.