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Executive Session: What Leadership Needs to Know

Purpose

To address CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Objectives  

1.     State the common 483 observations issued by the FDA.

2.     List the basic requirements of CGMP or  QSRs that require the attention of the leadership team.

3.     Identify gaps in compliance.

4.     Identify the issues that needs to be rectified.

About the Class

1. In-house projects will be used to demonstrate and practice the skills and principles of this class.

2. The optional final exam is approximately 25 questions.

3. Each student receives a student guide containing a representation of the program’s  slides and graphics with space provided for note taking.

4. This class can accommodate up to 25 people.

5. Duration: 8 hours.

Topics

Introduction

1.    Welcome

2.    Heard on the Street

3.   Observations in review: 483 Trends and consequences

4.   The Park Doctrine

21CFR211 or 21CFR820 Overview

Gap Identification

1.    Identify the critical elements of compliance

2.   Conduct a risk assessment of critical elements versus company practice

3.   Create a path forward

Wrap Up

Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500.

For a prompt reply to requests and questions:  415.487.3500   |  allan.dewes@skillsplusinc.com   |   Fax: 415.487.1926

©2011 SkillsPlus International Inc.