21 CFR Part 11,FDA,surveillance,Validation,Pharmac 2012 - Live webinar on Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection By compliance2go

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits

Areas Covered in the Session:

How to prepare for an FDA inspection

Development and contents of an SOP for FDA inspection

Personnel training before inspection

How to behave during an inspection

Limitations of scope of inspection

Response to investigation findings

FDA guidance documents used by their inspectors

Webinar Includes:

-Q/A Session with the Expert to ask your question

-PDF print only copy of PowerPoint slides

-60 Minutes Live Presentation

Who will benefit: The designations

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality system auditors

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.