Docstoc

Live webinar By Compliance2go

Document Sample
Live webinar By Compliance2go Powered By Docstoc
					 Live Webinar on :    Design History File (DHF), Device Master Record (DMR), Device History
 Record (DHR) and Technical File (TF) - Regulatory Documents Explained
 Wednesday, June 27, 2012 duration : 01:00 to 02:00 PM EDT




                                           Description


                                           Many citations by FDA and notified bodies include findings
                                           with respect to insufficient information in the Design
                                           History File, not following the procedures to make the
                                           device as established in the DMR and incomplete or
                                           inaccurate production data of incoming, in-process and
                                           finished products. Is your company able to access all
                                           relevant documents detailing the design of your device? Is
                                           your DMR accurate and is it being followed? Can the
Get 15 % Discount as a early bird          operators access your DMR? Are you recording and
registrations. Use Promo Key : CGO15       documenting all your production and testing data and
                                           maintaining them in the DHR?


                                           Areas Covered in the Session:

                                           -   DMR and outsourced design/production
                                           -   DMR and OEM relationships
                                           -   Controlling and maintaining DMR
                                           -   Device History Record (DHR)
                                           -   Definition
                                           -   Contents
                                           -   Using DHR data for tracking and trending
                                           -   DHR and outsourced design/production
Pricing                                    -   DHR and OEM relationships
                                           -   Technical File (TF)
                                           -   Definition
                                           -   Contents
Live ( Single registration ) : $189.00     -   TF and outsourced design/production
Group ( Max 10 Attendee): $249.00          -   TF and OEM relationship
On Demand (Recording available):$289       -   Design/process changes and DHF, DMR, DHR, and TF
Get Training CD : $399


Who will benefit
This Webinar is designed for people involved
in document preparation and maintenance,        About Speaker
and those who have involvement with
documentation. This typically includes:         Dr. Linda Yang, was until recently Associate Director,
                                                Regulatory Affairs for a pharmaceutical company. Currently as
Quality Managers/Engineers                      an independent consultant, she provides directions for
Production/Process Managers/Engineers           regulatory strategy, regulatory submission, clinical studies,
Manufacturing Managers/Engineers                CMC requirements for different development stages, product
QA and QC managers, inspectors,                 indications, and labelling.
supervisors and personnel
Documentation Specialists                       She has spent last 19 years working for pharmaceutical
Supplier Quality Managers/Engineers             companies and is an expert in regulatory and quality
                                                compliance. She has broad background and played leadership
                                                role in functional areas such as product development, business
                                                process optimization, quality compliance, clinical development,
                                                and regulatory strategy. She had hands on experience on
                                                global regulatory management and submission. She has
                                                experience working with US, European and other global
                                                regulatory regulations. She co-authored the book of the
                                                Fundamentals of US Regulatory Affairs (2009).

                                                Dr. Yang currently teaches regulatory affairs and compliance
                                                for University of Berkeley Extension, and regulatory and
                                                pharmaceutical development for Pharmaceutical Training
                                                Institute (PTI).

                                                 Dr. Yang obtained her Ph.D in 1992; MBA in 2004;
                                                Certifications of Regulatory Affairs (RAC) and Quality Auditor
                                                (CQA) in 2009.




   https://compliance2go.com/index.php?option=com_training&speakerkey=15&productKey=83

                               Compliance2go | www.Compliance2go.com
                               Phone : 877.782.4696 | Fax : 281-971-0286
                                 Email : Support@compliance2go.com