Biotechnology 2013 - Management FDA Inspections and Response for 483’s

Management FDA Inspections and Response for 483’s
From: $171
Date and Time: Friday, 27th September, 2013 | 11:30 A.M. to 1:00 P.M. EDT
Duration of the Training: 90 mins
Speaker: Dr. Linda Yang
Name of Topic:
Management FDA Inspections and Response for 483’s
Level of the Training:
Beginning to mid level
Why Should You Attend:
To understand FDA inspection process, general process, and how to handle the response.
Description of the Topic:
FDA inspections are time consuming and labor intensive processes, a company should prepare for it properly. The most important preparation to understand how to handle the inspection, the general process and how to prepare the response for 843’s if you receive any. The Webber helps you preparing and managing FDA inspections.
Areas Covered in the Session:
FDA inspection general, process, preparation and response for 483’s
Who Will Benefit:
To understand FDA inspection process, general process, and how to handle the response.
Instructor Profile:
Dr. Linda Yang, was until recently Associate Director, Regulatory Affairs for Norgine Pharmaceutical LTD. Currently as an independent consultant, she provides directions for regulatory strategy, regulatory submission, clinical studies, CMC requirements for different development stages, product indications, and labeling.
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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