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CfPA

Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites

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Overview / Abstract:

Who Should Attend?
This overview course is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:

• Top Management
• Quality Assurance/Control
• Regulatory Affairs
• Auditing
• Engineering
• Research & Development
• Quality Systems Management
• Documentation Management

The course will focus on various types of inspections in the pharmaceutical, medical device and related industries and will look at policies, procedures and experiences relevant to those inspections.

Course Description
This course provides an overview of the FDA inspection process in general and of particulars applicable to “foreign inspections”. It provides a background and understanding of the role played by the Agency, its administrative and enforcement powers. The course provides a step by step description of the inspectional process with specific examples regarding cGMP compliance inspections and pre-approval inspections.

The FDA initiatives regarding inspections, like risk based approach and system based approach, will be discussed in detail. This will enable participants to better understand how to prepare their companies for FDA inspections.

The course consists of lectures, discussions, and hands-on case studies.

Expiration

Jun 05, 2018

Discipline(s)

Education (Higher Ed)

Format

Live / Seminar, Podcast

Cost

$2280

Credits / Hours

1.2 CEUs

Accreditation

IACET, ASQ

Presenters / Authors / Faculty

Renée B. Galkin; Quality Management Consultant

Keywords / Search Terms

CfPA FDA Inspection, Non-U.S. Sites, cGMP compliance, case studies Seminar CE CME

LIVE Activity Location Details

Date(s)
06-04-2018 - 06-05-2018

Amsterdam, The Netherlands
 
Netherlands

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