The necessity for preventing or controlling (cross-) "contamination" in the storage, handling and processing of components, materials and products (non sterile and sterile) is demonstrated by the clear and consistent messaging in the GMPs:
- 40+ references in PIC/S Guide to GMP for Medicinal Products Part I (PE 009-14)
- 20+ references in FDA 21 CFR Part 211 CGMP for Finished Pharmaceuticals
This course will help you:
- understand why contamination control is critical
- understand the GMP rules that you must comply with regarding contamination control
- identify types and major sources of contamination
- implement procedures to reduce contamination risk in compliance with GMPs
- Introduction to Contamination Control
- GMP principles and requirements for contamination control
- Different types of contamination and the potential sources of contamination
- Risk assessment methodologies that can be used to analyse and assess the major risks to product
- Develop strategies for contamination control
- Cleaning and Sanitation
- Suitable cleaning and disinfectants for different manufacturing situations
- Appropriate techniques for cleaning and sanitation
- Operating in a Cleanroom
- Cleanroom facilities, HVAC and filtration principles
- International cleanroom standards
- Cleanroom garments, gowning procedure and qualification
- Cleanroom conduct and operator qualification
- Cleanroom operation and control
- Environmental monitoring
- HVAC and Controlled Environments
- The international nomenclature and classification of cleanrooms
- Key design requirements for cleanrooms
- The theory of particle filtration, 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
- Environmental Monitoring (EM)
- Key elements of an Environmental Monitoring (EM) Program
- EM sample sites for qualification and routine monitoring purposes using risk assessment
- Testing required for demonstration of cleanroom standards
- Strategies for defining sample sites & frequency
- Strategies for establishing alert & action levels for EM
- EM test methods and examples of where and when they will be used
This course has been designed to provide personnel of all levels (Operator, Officer, Supervisor, Manager) with a good understanding of contamination and how to control it in a GMP environment. People from a range of Departments (Production/Manufacturing/Packing, Quality Control, Quality Assurance, Engineering etc.) will benefit from this training.
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 will be delivered as 2 full day sessions, with breaks.
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.
Each participant will attend both full-day sessions:
|Day 1||12th September 2022||9:00am-5:00pm|
|Day 2||13th September 2022||9:00am-5:00pm|
Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00
Fee and Discount
- AUD $1,300 (exc. GST) per participant
- A 10% discount applies for 3 or more participants from the same company
Registration is not yet open as session dates are not yet confirmed, pending review of the update to PIC/S Guide to GMP Annex 1 review and impact on this course
Contact us to discuss your interest in a public or private delivery of this course.