Olympics for CGMP
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We also recommend: [Olympics for Medical Device Manufacturers] [Qualstar Simulation - An Advanced Course]

 

Olympics for Pharmaceutical and Biotech Manufacturers

 

 

Purpose

To take CGMPs to a deeper level of understanding through a series of challenging activities

 

Objectives  

1.     List the hottest issues in CGMP compliance.

2.     Locate items of interest in 21CFR211.

3.     Explain the 21CFR211 rationale for specific 483 observations.

4.     Demonstrate knowledge of common CGMP practices and details.

5.     State the consequences of not following CGMPs.

 

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 10-15 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: 4-8 hours. Depending on the project selected, this class may take several days.

Topics 

Introduction

1.   Agenda

2.   Ground rules

3.   New issues and practices

 

Heard on the Street

1.   21 CFR 211

2.   Activity: Brainstorming questions about CGMP

3.   Open discussion   

 

Client directed presentation 

Time variable based on learning objectives

 

Inspection Detection

1.   Review 483 observation note

2.   Link observation to 21 CFR 211

 

CGMP Challenge

1.   Client selects 4 topics from a list of 18

2.   Questions are presented

 

Wrap Up

1.   Activity: Brainstorm important points to remember from the class

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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