PDA Manage Your Isolator for Aseptic Processing Training Course
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Registration Options
Individual Registration
Group Registration
This interactive training course takes place at the Skan Academy in the newly built Skan Headquarters in Basel.
On the first day, participants will get an overview of all aspects of the isolator. Theory and hands-on units are offered. On the second day, the focus is on glove handling. Theoretical units alternate with hands-on units, so that the participants can experience what they have heard live.
During the training course there is enough time and space for exchange of experiences and discussions. For this reason, the training course is designed for a limited number of participants only.
Who Should Attend
- Operators
- Manufacturing Supervisors
- QA Managers
Learning Objectives
Upon completion of the course, participants have understood:
- the different components of an isolator
- the interactions between the different components
The participants have learned:
- the relevant GMP regulations and other guidelines
- the do's and don'ts in daily operations
- the basic principles of maintenance, calibration, and validation
The participants can perform:
- glove testing
- handling of settle plates
- transfer of items in and out of isolator
In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 week in advance. Hard copies of course notes will not be provided to participants.
Program Highlights
An additional highlight is the joint dinner at the end of the first training course day, where participants and trainers can get to know each other better and expand their network. Don't miss this unique opportunity and reserve the evening for this get-together.Agenda
Discover What's Happening Each Day
(Note: The file may take a moment to download depending on your connection.)
CET Standard Time (UTC +1:00)
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Welcome and Introduction of Trainers and Participants
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Isolator Basics (Theory)
- Application of isolators
- Technical basics
- Components
- Annex 1
- Containment/ Cleaning
- Gloves
- Ports
- Process components
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Regulatory View on Annex 1
- Principles
- Key Changes
- Points to Consider
-
-
Coffee Break and walk to the Academy
-
Workshop in 2 Groups
-
Filters in Practice (Academy)
- HEPA filter, safe filter change, and test
-
Lunch Break
-
Walk through the SKAN Assemly Hall
Showing examples on large filing lines, small scale filing lines, and material transfer systems.
-
-
Requirements for Environmental Monitoring
- What are the GMP Requirements?
- Find the right Position in the Isolator System
-
-
Coffee Break
-
Cleaning SKAN CleanIP - SKANalytix
- What is important to prepare cleaning
- What is the right method to perform cleaning and how to quanitfy clean
-
-
Q&A from Day 1
CET Standard Time (UTC +1:00)
-
Recap Day 1
-
Theory/Practical
-
Gloves on the Isolator (Theory)
- Requirements for gloves
- Tightness (pressure, liquid)
- Insensitivity to media
- Handling by operator
- Positioning in the isolator through mock-up studies
- How do different gloves and designs look like
- Manufacturer
- Materials
- Requirements for gloves
-
Microbiological Monitoring on Gloves (Theory/Practical)
- Swab test - Microbiological testing
-
-
Coffee Break and walk to the Academy
-
Gloves on the Isolator (Practice)
- Explanation of technical specification of the isolator
- Material and design of gloves
- Positioning of gloves in the isolator (various examples)
- Mock-up study (example)
- Installation and removal of the gloves
- Working with/in the gloves on practical examples
- "Easy" example
- "Difficult" example
- Tightness
- Visual inspection
-
-
Lunch Break
-
Biological Indicators BI's
- What is important to consider using BI's for the validated decontamination cycle
-
-
Decontamination (Theory)
- H2O2 as decontaminating agent
- Properties
- Concentration
- Interaction with water
- Cycle development
- Validation
-
-
Decontamination (Praxis Academy)
- Preparation for decontamination
- Start cycle
-
-
Q&A from Day 2
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA recommends the reservation at the following hotel
Holiday Inn Express
Hegenheimermattweg
179 Allschwil / Basel
Switzerland
The hotel is located five minutes walk from the training course venue.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
€2,200Non-Member
€2,350
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
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