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
Content
Facility Layout and Design Principles- Demonstrate various approaches to design development and project management for pharmaceutical facilities
- Define conceptually the difference between Sterile and Solid Dose manufacture
- Describe the current options for the design and layout of a manufacturing facility under Good Engineering Practices
- Appreciate the different surface finishes and options
- Understand cleanroom design for containment
- The process of selection, design, installation, qualification and validation of a Clean Steam System
- An overview of the requirements for compressed air and other gasses
- 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
- The international nomenclature and classification of cleanrooms.
- Key design requirements for cleanroom
- The 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
- GMP deficiencies
- Requirement Specifications and Design Qualification
- GMP requirements for IQ, OQ, PQ
- The role of commissioning, FAT and SAT in equipment qualification
- The fundamentals of compiling IQ, OQ, PQ protocols and reports
- Introduce Planned Preventative Maintenance (PPM) within a GMP facility
- Develop PPM packages; discuss software and hardware requirements
- Compile a Calibration Data Base
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
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes.
The course will be delivered live, Face-to-Face in a training room over 2 full day sessions, including breaks, with a lively mix of case study workshops and intensive tutorial sessions. The delivery method is collaborative with a group and facilitator which has been shown to enhance learning and critical thinking skills. Content is current and relevant, so knowledge and value are gained immediately.
Morning tea, lunch and afternoon tea will be provided each day and is included in the ticket price.
Session Details
Participants will attend both full-day sessions.
Venue
Lakeside Hotel & Conference Centre
1 Executive Road
Macquarie Park NSW 2113
| Sessions | Dates | Times (Sydney) |
| Day 1 | 01 July 2025 | 9:00am-5:00pm |
| Day 2 | 02 July 2025 | 9:00am-5:00pm |
Fee and Discount
- AUD $1,600 (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.
