FDA Compliance and Quality inspections

This FDA quality inspection training will focus on FDA’s current thinking on cGMP requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act. The Food and Drug Administration is using a new approach to inspections as a part of their cGMP Initiative for the 21st Century

This presentation will focus on FDA’s current thinking on cGmp requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act, FDA’s inspectional procedures and process, what firms can do to facilitate and prepare for inspections, FDA’s new approach utilizing quality systems and current FDA 483 findings.

Areas Covered in the seminar:

• Overview of FDA’s statutory inspectional obligation, new inspectional approach for the pharmaceutical industry
• Background on FDA’s inspection authority
• FDA’s inspectional procedures and process
• How to prepare for the inspection
• How to facilitate the inspection
• What the inspection will cover
• FDA’s New Inspectional Approach
• Common GMP deficienceis and recent 483 findings

Who Will Benefit:

This webinar will provide valuable assistance to those firms and individuals who are regulated by the U.S. Food and Drug Administration and subjected to FDA inspections and oversight. The employees who will benefit include:<.p>

• Management
• Production Employees
• Quality Control Managers and Personnel
• Laboratory employees