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We also recommend: [Essentials for Pharmaceuticals] [Essentials for Medical Devices

 

GMP Essentials for API Manufacturers

 

 

Purpose

To be able to apply Q7A to the manufacturing operation in preparation for an FDA or customer audit.

 

Objectives  

  1. To state the many requirements of Q7A.

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 as a minimum. Depending on the project selected, this class may take several days.

Topics

 

Introduction

1. Definitions

2. Observation Trends

3. History

 

Quality Management Systems

Quality Assurance

Organization and Personnel

Buildings and Facilities

Equipment

Documentation

Materials

Production and Process Controls

Packaging

Quality Control

Validation

Change Control

Rejected Product

Recalls

Clinical Exceptions

Special Topics

 

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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