FDA Inspections Preparation and Management

							 Live Webinar on : FDA Inspections Preparation and Management
 Wednesday, June 27, 2012 duration : 01:00 to 02:00 PM EDT




                                            Description


                                         For everyone involved, FDA inspections are time
                                         consuming and labour intensive processes, but
                                         they need not be frustrating or mysterious if a
                                         company has prepared properly. The most
                                         important preparation is complying with the
                                         pertinent laws and regulations, including
Get 15 % Discount as a early bird        developing and implementing an effective quality
registrations. Use Promo Key :           system. The webinar helps you preparing and
 CGO15                                   managing FDA inspections.

                                         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
                                         - DHR and OEM relationships
Pricing
                                         - Technical File (TF)
                                         - Definition
                                         - Contents
                                         - TF and outsourced design/production
Live ( Single registration ) : $189.00   - TF and OEM relationship
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289     - Design/process changes and DHF, DMR, DHR,
Get Training CD : $399                   and TF
Who will benefit
Everybody who may involve FDA
inspections.
Executive/senior management
Regulatory management
QA management                             About Speaker
Any personnel who may have direct
interaction with FDA officials            Dr. Linda Yang, was until recently Associate Director,
Consultants                               Regulatory Affairs for a pharmaceutical company. Currently as
Quality system auditors                   an independent consultant, she provides directions for
All Regulatory Professionals              regulatory strategy, regulatory submission, clinical studies,
                                          CMC requirements for different development stages, product
                                          indications, and labelling.

                                          She has spent last 19 years working for pharmaceutical
                                          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.


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