VIEWS: 6 PAGES: 2 POSTED ON: 10/2/2012
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. https://compliance2go.com/index.php?option=com_training&speakerkey=15&productKey=129 Compliance2go | www.Compliance2go.com Phone : 877.782.4696 | Fax : 281-971-0286 Email : Support@compliance2go.com
"FDA Inspections Preparation and Management"