Live Webinar on FDA Inspection Preparation Guide: Handling 483s and Warning Letters
View: 133
Website https://bit.ly/2XhVkZ6 |
Edit Freely
Category FDA Inspection;Types of FDA inspections;FDA 483 observations
Deadline: March 26, 2019 | Date: March 26, 2019
Venue/Country: Training Doyens 26468 E Walker Dr,Aurora, Colora, U.S.A
Updated: 2019-02-22 16:09:31 (GMT+9)
Call For Papers - CFP
OVERVIEWIn this webinar you will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and responding to 483s and FDA warning letter.How to respond and when is critically important.Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.WHY SHOULD YOU ATTENDFDA is required to conduct an inspection every two years. A company that is prepared for FDA audits is less likely to receive 483’s than a disorganized company.If a 483 is received knowing how to respond will lessen chances of receiving an FDA warning letter.AREAS COVERED• Personnel preparation• Procedure to follow during FDA audits - what to do/ what not to do• Facility requirements to support FDA inspection• Behavior during inspection-what not to sign• Internal/ mock audits• 483s/ FDA Warning Letter responseLEARNING OBJECTIVESLearn how to be always prepared for FDA inspections and how to handle 483s and FDA warning letter. Also understand the significance of mock audits.WHO WILL BENEFIT• Engineering personnel• Engineering management• Quality/ regulatory Management• Corporate Management• Manufacturing Management• Division management• Legal counselUse Promo Code MKT10N and get flat 10% discount on all purchasesFor more detail please click on this below link: https://bit.ly/2Nn7MSJEmail: supporttrainingdoyens.comToll Free: +1-888-300-8494Tel: +1-720-996-1616Fax: +1-888-909-1882
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.