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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
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 © 1991-2015 SkillsPlus International Inc.
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