Engineering is responsible for many critical elements of the GMP facility as well as equipment and systems within the facility. To help GMP Engineers meet their regulatory compliance obligations, SeerPharma offers this dedicated course to address specific needs.

On completion of this course you will be able to:

  • Describe basic facility layouts and their principles
  • Describe the current international industry standards for utilities such as water, pharmaceutical gases and cleanroom HVAC
  • State the requirements for design, control and validation of pharmaceutical water systems
  • State regulatory requirements for HVAC systems & environmental monitoring of cleanrooms
  • Implement the GMP requirements for qualification of facilities, equipment and utilities
  • Review the GMP standards & requirements for preventative maintenance and calibration

GMP Engineers in Plant Room

Content

Introduction to GMP

  • Basics of GMP and application to Engineering

Facility Layout and Design Principles

  • Design development and project management for pharmaceutical facilities
  • Options for the design and layout of a manufacturing facility under Good Engineering Practices
  • Surface finishes and options
  • Cleanroom design for containment

Cleanrooms – Design, Control and Qualification

  • The international nomenclature and classification of cleanrooms.
  • Key design requirements for cleanroom
  • Theory of particle filtration, and controlled facilities design and operation for the purpose of product protection
  • Certification of cleanrooms: test methods, test instructions, sampling sites
  • Rules for working within a cleanroom
  • Relevant GMP deficiencies

Design and Construction of Critical Utilities - Clean Steam, Gases

  • Process of selection, design, installation, qualification and validation of a Clean Steam System
  • Overview of the requirements for compressed air and other gasses

Water Systems: Design, Control & Validation

  • Planning and Programming Water Systems
  • Feedwater Characterisation
  • Water Purification System – Microbial Considerations
  • Basic System Review
  • Pre-treatment
  • Purification
  • Storage and Distribution
  • Rouging, Stainless Steel and Passivation
  • Sampling
  • Automation, Instrumentation and Trending

Facility, Equipment and Utilities Qualification

  • Requirement Specifications and Design Qualification
  • GMP requirements for IQ, OQ, PQ
  • Role of commissioning, FAT and SAT in equipment qualification
  • Fundamentals of compiling IQ, OQ, PQ protocols and reports

Planned Preventative Maintenance and Calibration

  • Planned Preventative Maintenance (PPM) within a GMP facility
  • Calibration database
Participants

This course has been designed for all GMP Engineers responsible for design, commissioning, qualification, validation and maintenance of GMP facilities, equipment, services and utilities.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training is delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.

An online quiz assessment will be issued by SeerPharma on e-mail after delivery of the course is complete.

A digital credential (badge) will be issued from Credly on e-mail after the quiz assessment is passed.

Session Details

Participants will attend both full-day sessions.

 Sessions  Dates  Times
 Day 1  17 November 2026  9:00am-5:00pm
 Day 2  18 November 2026  9:00am-5:00pm

 Times are based on Melbourne, Australia.

Fee and Discount

  • AUD $1,500 (excluding GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

If you can't see the booking window to select tickets below, please click here.

 

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions