We also recommend: [Executive Session: What Leadership Needs to Know] [Management Session: What Every Manager Needs to Know] [Surviving an FDA Inspection] [Meetings for Swift and Aggressive Regulatory Enforcement]

Creating CGMP and QSR Responsibility and Accountability

Purpose

To raise the standard of CGMP and QSR compliance throughout the organization, and to provide strong and positive coaching techniques.

Objectives  

1.   Review the CGMP/QSR Regulations.

2.   Set climate for a compliance discussion.

3.   Create a compliance message.

4.   Provide behavioral feed back.

5.   Create responsibility for CGMPs and performance.

6.   Establish an atmosphere of accountability.

7.   Hold non-threatening discussions with employees as a part of a corrective action plan.

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 18 people.

5. Duration: 8 hours.

Topics

Introduction

1.   Understanding the regulatory environment

2.   Knowing the consequences

Direct Reports

1.   Five elements for success

2.   A risk assessment against the elements of success

Communication Skills for Supervisors and Leaders

1.   Introversion / extroversion scale

2.   Non-verbal communication

3.   Communicating with the boss and peers

4.   Listening

5.   Paraphrasing

Motivation

1.   Overview

2.   Frame of mind

3.   Maslow

4.   Herzberg

5.   What employees care about

Goals

1.   Observable

2.   Measurable

Delegation

1.   Overview

2.   Supervisors and delegation

3.   Employee resistance

4.   The drama triangle

5.   Delegation: Hold or delegate

6.   Dealing with resistance

7.   Empowerment

8.   Change

The Compliance Message

1.   Overview

2.   Issues and expectations

3.   A model for change

4.   Responsibility and accountability: Part 1

5.   Dealing with resistance in the compliance message

6.   Responsibility and accountability: Part 2

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 415.948.5220.

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

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