Environmental Monitoring - Online Training Recording
Course No. 21006A
Speakers
Arjan Langen
GE Healthcare
Chris Randell
CooperVision
Dr. Björn Wiese
Janssen Cilag
Objectives
Environmental monitoring is one of the systems that decide about the product quality in the manufacture of sterile medicinal products. Both European and American GMP regulations place special focus on this topic.
The USP 1116, the new EU GMP Annex 1 and especially the FDA’s “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice“ deal in detail with environmental monitoring.
However, many of the requirements laid down in these documents seem to be excessive for everyday practice on the one hand and leave great scope for interpretation on the other hand.
In practice, environmental monitoring programmes sometimes develop into time-consuming, cost- and personnel-intensive measures. Therefore, it is the aim of this Online Training to provide the participants with pragmatic recommendations for the creation and implementation of environmental monitoring programmes.
Within the framework of this Online Training, the participants are confronted with current hot topics, like:
Alert / action levels
Relationship to batch release
Locations and frequency
Identification of isolates
Sampling procedures
and get to know solutions for their own company practice.
Target Group
This Online Training is directed at staff from Production, Quality Assurance and Quality Control who is responsible for the planning and implementation of environmental monitoring programmes.
It is also valuable for decision makers who have to deal with environmental monitoring data within the framework of product release.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
Environmental Monitoring
Why do we do it – what does it tell us?
Relevant Guidelines
The new EU-GMP Guide Annex 1
USP <1116>
FDA Aseptic Processing Guide
ISO 14644 and ISO13824
An overview about the most important guidances
Surface / Personnel Monitoring
Surface:
How?
Surface sampling techniques
Limitations
Validation?
Personnel:
When and how?
Results and specifications
How to deal with shedders/pathogen carriers.
Viable Air Monitoring
Regulatory Standards
Settle Plates
Validation
Drying Issues
Where to place them?
Active Air Sampling
Equipment options / comparison
Validation
Where to place them?
Clean Rooms – RABS – Isolator: Points to consider in Environmental Monitoring
Comparison of the technical concepts
Validation of microbiological media for the isolator
Selection of sampling points
Transfer of microbiological media
Interpretation of the results and handling of excursions
Non-viable (particulate) Air Monitoring
The grading of areas for manufacture of sterile medicinal products in the EU
How to claim classification of areas to current standards
How to ensure continuing compliance with the classification
Selection of sampling locations for qualification and routine
Particle monitoring, how and how often
Handling the data
How to Establish an Environmental Monitoring Programme / Use of FMEA to Determine Sample Points in Routine Monitoring
Identifying weaknesses in contamination control systems
Identifying locations which will provide “early warning” signals of loss of control
Preparing useful environmental monitoring SOPs
Keeping manageable records
Trending of Environmental Monitoring Data
What is a trend?
How can I use electronic systems to track and trend EM data?
How to get meaningful information from trending
Alert and action level setting
Using trending as tool for pro-active environmental control measures
Microbiological Methods
Microbiological media, growth requirements
Identification of isolates
Validating your methods
Using rapid identification techniques
Recovery problems
Identification to the level of DNA, what value does it bring
Environmental Monitoring for Medical Devices
Environmental Monitoring requirements considering ISO and AAMI
Classified Cleanrooms
Controlled Environment
Real life example
What to do when excursions occur?
Environmental Monitoring for Non-Steriles
Why monitor non-sterile areas
Risk vs impact
Overview of regulatory position
Case study
Deviation Management for Environmental Monitoring
Steps to be taken in case of excursions
When is an excursion a deviation?
Comprehensive root cause analysis
The nasty “re-occurrence”
Finding of appropriate actions
Interpretation of OOS Results
What is an OOS in environmental monitoring?
OOS in relation to trends
How to investigate
Follow-up and corrective actions
Consequences for batch release
Investigations / Documentation
The information content of “variable” data versus quantitative limits
Published and practical limits
The information content of qualitative data
Communicating with technical management and higher management
Recording from 16 May 2023 Duration of the recording: approx. 10 hours
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager" Learn more
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