Developing a Pharmaceutical Contamination Control Strategy
The EU GMP Annex 1 revision has indicated that each company has a contamination control strategy. But what does such a strategy look like? What are the core elements? And how can risk assessment be used to address any identified gaps?
A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event).
This course provides practical tools with a multidisciplinary approach for understanding types of contamination, contamination control measures, the application of risk tools to address concerns, in line with regulatory expectations.
Interested in contamination control strategy training for your team? Contact us today.
The course is suitable for pharmaceutical professionals working within Quality Assurance, Operational Quality, Quality Control, Microbiology, Sterility Assurance, Production, Engineering and specifically, Qualified Persons, Quality Managers, QMS Specialists, Pharmaceutical Microbiologists, Quality Control Managers, Production Managers, Head of Quality and Compliance Managers etc.
This course covers the following topics:
Microbial contamination
Sterility assurance
Facility design
Chemical contamination
Particle contamination (visible and sub-visible)
Viral control
Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations.
With guidance on how to identify, connect, risk assess, document and resolve the essential aspects.
At the end of the course, delegate will understand:
What regulators expect from a contamination control strategy
The different forms of contamination and the importance of a holistic response
How to assess gaps in a programme
The importance of sterility assurance to such an assessment
How to apply different risk tools to map the process
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
Contact us to register your interest and we will update you when course dates are confirmed.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
