FDA Inspection, understand FDA,implementing FDA, e 2012 - Live web confrence on FDA Inspections Preparation and Management By compliance2go

Why should you Attend :

Who want to understand FDA inspection, and maybe involve FDA inspections in the future?

Description of the event:

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 developing and implementing an effective quality system. The webinar helps you preparing and managing FDA inspections.

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Areas Covered in the seminar:

Introduce background information for FDA inspections

Describe FDA inspection procedure

Analyses inspection outcomes

Provide insight into elements that should be considered in developing a response.

Who will benefit: (Titles)

Everybody who may involve FDA inspections.
Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality system auditors
All Regulatory Professionals

About Speaker

Dr. Linda Yang, was until recently Associate Director, Regulatory Affairs for a pharmaceutical company. Currently as an independent consultant, she provides directions for 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.