FDA Inspection Preparation and Management: Important Considerations

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Category Houston

Deadline: March 23, 2016 | Date: March 23, 2016

Venue/Country: Houston, U.S.A

Updated: 2016-02-09 18:59:42 (GMT+9)

Call For Papers - CFP

Wednesday March-23-2016 01:00 PM | 02:00 PM - EST

DESCRIPTION

This webinar is intended to provide practical and actionable information and guidance on how to proactively prepare for a sustainable FDA inspection and to better manage FDA inspection processes including key points of consideration.

This webinar is further intended to discuss and understand FDA’s inspection authority, compliance programs and Agency’s change in inspection policy.

This presentation will greatly help industry better understand the FDA inspection processes with increased awareness.

As a result, you will plan and execute your FDA inspection preparation and management differently in a way to bring more values to your organization ? saving a significant amount of time and resources.

Why should you attend :

This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection including important points of consideration.

Areas Covered in the Session:

Laws and Regulations

FDA Inspection Authority

FDA Manuals for Inspection

Hosting an FDA Inspection

Inspection Types, Categories and Classification

Inspection Process

FDA Forms 482 and 483

Responding to 483s

Why/How/What to Consider for Inspection Preparation and for Better Management

Common Mistakes and Critical Points of Consideration

Laws and Regulations

FDA Inspection Authority

FDA Manuals for Inspection

Hosting an FDA Inspection

Inspection Types, Categories and Classification

Inspection Process

FDA Forms 482 and 483

Responding to 483s

Why/How/What to Consider for Inspection Preparation and for Better Management

Common Mistakes and Critical Points of Consideration

Speaker’s PASS-IT Recommendations

Who will benefit: (Titles)

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

R&D

Consultants

Contractors/Subcontractors

Anyone Interested in the FDA inspection Processes

Webinar Includes:

Q/A Session with the Expert to ask your question

Copy of PowerPoint slides (PDF print only)

60 Minutes Live Presentation

Certificate of Attendance