Online conference Hosting Regulatory Inspections

Website https://compliance2go.com/product/?pid=CP2014-369 | Edit Freely

Category Biotechnology , Healthcare , Medical Device , Pharmaceutical

Deadline: October 30, 2014 | Date: October 30, 2014

Venue/Country: Houston, U.S.A

Updated: 2014-10-16 17:47:52 (GMT+9)

Call For Papers - CFP

Being inspected by a regulatory agency, whether the FDA, foreign regulatory agencies (e.g. European, Japanese) or any agency regulating parts of the pharma, biotech or medical device industries, e.g. for CLIA certification, is a normal part of doing business. Yet many companies are unprepared for such an inspection resulting in citations or other adverse action by the agencies.

Why should you attend/Description of the topic:

The course will go through what typically goes on during an FDA inspection and the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures.

The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self inspections for manufacturing. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.

Finally, the course will provide information on how to respond to issues that come up during inspections and what to do to ensure best outcome from the inspection.

Areas Covered in the Session:

Types of inspections

What goes on during the FDA inspection

What goes on during an international inspection

What goes on during a CLIA inspection

Who is involved

The SOP for Inspections

What if you are asked to talk to the inspector

What do you allow the inspector to have access to

How to follow up after the inspection

How to respond to any adverse inspection findings

How to eliminate adverse inspection findings

Who will benefit:

Anyone who would be involved in the trial

Regulatory Affairs professionals

Quality Assurance

Physicians

Nurses

Lab Technicians

Operations

Clinical Data Management

Laboratory Management

Manufacturing

IT

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance