When it comes to approving a medicinal batch, EU GMP Chapter 6 requires that “Production conditions” are taken into consideration. Environmental Monitoring is one such essential consideration.
This practical, one-day course addresses environmental monitoring for the manufacturing and other controlled locations for both sterile and non-sterile pharmaceutical products. It examines the legislation and guidance available, the techniques employed to monitor pharmaceutical environments, data trending, and how to manage out-of-limit results.
Interested in Environmental Monitoring training for your team? Contact us to discuss your in-house training needs today.
This course is ideal for personnel in production, quality, and microbiology functions who wish to increase their understanding of regulatory requirements and expectations for the environmental monitoring of pharmaceutical operations.
It will be of particular value to:
• Anyone performing environmental monitoring as part of their role
• Those involved in collating and interpreting EM results
• Personnel responsible for developing or reviewing monitoring programmes
• Staff who need to understand GMP requirements for environmental control
No prior specialist knowledge is required — this is a comprehensive introduction designed to build your confidence and competence.
This course covers the following topics:
Regulatory requirements and guidance (including EU GMP Annex 1)
Overview of testing techniques used in pharmaceutical environments
Developing an effective monitoring programme
Workshop: Risk-based monitoring
Calculating compliance limits
Identification of microorganisms detected during monitoring
Interpreting results and understanding what they mean for your operations
Workshop: Identifying adverse trends
Workshop: Why trending of microorganisms is useful
By the end of this course, you will:
Understand the testing techniques regularly used in pharmaceutical production operations
Know how to interpret results and identify trends
Know what factors to consider when developing an environmental monitoring programme appropriate for your operations
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
| Yes, the Environmental Monitoring course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. |
| Places will be available for you to book unless it states ‘Full’ next to your chosen Environmental Monitoring course date. When this occurs, we operate a waiting list service. |
| Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. |
| You will need to first register yourself on our booking system by selecting the Environmental Monitoring course date that you wish to book your colleagues onto, then: - Add the number of people you wish to book onto the course - Register yourself as the booker and complete the fields accordingly - Add the details of those you wish to book for - Complete your order. |
| You will receive an automated email confirming your booking details for the Environmental Monitoring course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included. |
| Usually, this 1-day Environmental Monitoring course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000. |
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
| Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system. |
| Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. |
| Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. |
| Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email. |
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
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
