Project Management: Pharmaceutical Facility Build / Renovation

Provided by NUS Academy of GxP Excellence


Course introduction

Introduction


Objective

To understand the approach to designing and implementing project plans that comply with regulatory standards - GMP, 21 CFR Part 211 and FDA standards, develop project plan in the construction and renovation of pharmaceutical facility with proper documentation.

Description

This course is designed to provide an overview on the approach to building pharmaceutical facility while meeting regulations set up by various regulatory bodies such as FDA. The course addresses the rules, tools, and techniques to develop and manage such project.

Course Outline
• Good Manufacturing Practice (GMP)
• 21CFR Part 211
• Food and Drug Administration (FDA)
• Project Planning
• Pharmaceutical Facility Design Consideration
  o Regulations
  o Building and Zoning Codes
  o Support Utility Requirements
  o Building, Materials and Finishes
  o Safety
• Good Engineering Approach
• Project Commissioning
• Project Validation - The V-Model
• Project Planning and Schedule
•Project Life Cycle
• Project Team
• Documentation

Learning Outcome

Upon completion of this course the attendees will be able to:

1. Understand the various regulations and guidelines from regulatory bodies and industrial bodies such as 21 CFR Part 211, GMP
2. Understand all the elements in a Project Life Cycle
3. Understand the approach in the construction and renovation of pharmaceutical facility



Fees & Funding

Please enquire below for course fees and financial grants:


 

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