Aims and Objectives:

This course aims to introduce the requirements for design of facilities, equipment and processes in the pharmaceutical and related industries.

On completion of this course you will be able to:

  • Describe basic facility layouts
  • Review the GMP standards & requirements for engineering & maintenance services
  • Describe the current international industry standards for utilities such as water, pharmaceutical gases and cleanroom HVAC
  • State the requirements for design of pharmaceutical water systems
  • Develop a validation protocol for water system qualification
  • State regulatory requirements for HVAC systems & environmental monitoring of cleanrooms
  • Provide examples of environmental programs and interpretation of the data

Content:

This course consists of 4 modules or topics:

1 Facility Layout and Design Principles

  • Describe the current options for the design and layout of a manufacturing facility under Good Engineering Practices.
  • Demonstrate various approaches to design development and project management for pharmaceutical facilities.
  • Appreciate the different surface finishes and options.
  • Design cleanrooms for containment.

2 Design and Construction of Critical Services-Water, Gas, HVAC

  • Discuss GMP standards & requirements for engineering & maintenance services.
  • Appreciate current international industry standards utilities such as water, pharmaceutical gases and cleanroom HVAC.

3 Water Systems: Design, Control & Validation

  • Understand the requirements for design, validation & control of pharmaceutical water systems according to cGMPs.
  • Be familiar with water system validation guidelines, IQ, OQ & PQ requirements, current BP / USP standards and microbiological controls.

4 GMPs for Critical Equipment – IQ and OQ

  • Appreciate content of practical qualification protocols for critical equipment & the preparation of selected example IQ/OQ protocols.
  • Define the difference between critical and non-critical equipment.
  • Explain how to develop an equipment support, maintenance and documentation package ready for qualification.

Format and Course Length: 

The 3-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.

Scheduled sessions run from 9am to 5pm unless otherwise specified.

Call us or click here to e-mail us and register your interest.

 

Refer to the Terms and Conditions