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
ContentFacility 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
- Storage and Distribution
- Rouging, Stainless Steel and Passivation
- 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
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 full day sessions. Breaks are included.
PDF Certificates will be provided to participants electronically.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Participants will attend both full-day sessions:
|Day 1||10th November 2021||9:00am-5:00pm|
|Day 2||11th November 2021||9:00am-5:00pm|
Times are based on Melbourne, Australian Eastern Daylight Time (AEDT) / Coordinated Universal Time (UTC) +11:00.
Fee and Discount
- AUD $1,300 (excluding GST) per participant; introductory offer
- A 10% discount applies for 3 or more participants from the same company
New Session Dates To Be Advised
Contact us for clarification or to discuss your interest in a public or private delivery of this course.