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Give us a call at (415) 487-3500 so we can discuss with you your training needs!

Trainer Certification: CGMP and QSR Trainer Readiness Course

Purpose

To develop the training skills necessary to facilitate greater knowledge of relevant regulatory requirements, and to help others apply that knowledge in the work environment..

Objectives  

1. Demonstrate ability to participate in professional discussions of basic CGMP or QSR regulations.
2. Apply CGMP or QSR knowledge through interactive activities.
3. Model support of compliance through individual inquiry and discussion.
4. Design, construct and facilitate instructional activities based on learning taxonomies and domains.
5. Use proven activity debrief strategies to emphasize important learning objectives.
6. Develop and present interesting case stories relevant to CGMP or QSR training topics.
7. Deliver energizing presentations that keep employees involved and engaged.
8. Facilitate discussions to encourage student interaction and instill greater understanding.
9. Manage disruptive employees in the classroom environment.
10. Model proven strategies in responding to difficult questions.
11. Identify the fundamental elements of test construction and test validation.
12. Demonstrate breadth of CGMP knowledge through responses to written and verbal quiz questions.

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 15 people.

5. Duration: 40 hours.

Topics

Introduction

Monday
History of FDA, CGMP, QSR
Organization and Personnel
Personnel Responsibilities 
Training
Hygiene, Illness, & Gowning
Management Responsibility
Documentation
Electronic Records
Materials
Purchasing Controls
Acceptance Activities
Quality Control
Buildings and Facilities
Purchasing Controls

Tuesday
Production and Process Controls
Equipment
Calibration
Design Controls
Process Validation
Quality Management System
Qualstar Simulation
Effective Presentation Flow

Wednesday 
21 Learning Domains for Meaningful Activities
Cognitive Domain
Affective Domain
Psychomotor Domain
Designing Meaningful Activities
Facilitation Behaviors During Classroom Activities
6 Levels of Questioning for Discussion 
Linking Discussions to Learning Objectives
Responding to Difficult Questions
Debrief Strategies
Classroom Workgroup Formation
Story Telling for Retention

Thursday
Effective Presentation Skills
Student Presentations
Goal Setting for Improvement

Friday
Managing Disruptive Students
Tests and Measurements
Student Presentations

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.