Container Closure Integrity Testing for the Advanced User
Registration Options
Individual Registration
Group Registration
Program Highlights
This Course will take place at the Wilco AG facilities.Participants are encouraged to bring their own samples for discussion!
This two-day training course provides detailed insights on Container Closure Integrity Testing (CCIT) on an advanced level. Participants will earn all about the development of container closure systems for sterile drug products throughout shelf-life.
Subject matter experts present the latest regulatory landscape and industry expectations for CCIT. Additionally, best practices for methods development, testing technologies, test set-ups, as well as the creation and handling of positive control samples are shown.
The course takes place at the Wilco facility in Wohlen/Switzerland and includes hands-on learning sessions for different types of equipment.
Participants are encouraged to bring their own samples for discussion!
After completion of the course the participants
- understand the regulatory environment on an advanced level
- can explain strengths and weaknesses of the technologies in detail
- can select the appropriate method
- understand different concepts of positive controls and can evaluate the pros and cons of different positive control strategies
- understand and apply method development
- understand and operate the methods on an advanced level
- are enabled to evaluate their QC approach themselves
Contact
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Standard Registration
Member Price
€1.595GovernmentMember Only
€1.595
Health AuthorityMember Only
€1.595
Early Career ProfessionalMember Only
€1.595
StudentMember Only
€1.595
AcademicMember Only
€1.595
Non-Member
€1.595
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
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 registration-europe@pda.org 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.
Day 1
Thursday, 27 February 2020
Kronenplatz 20
5600 Lenzburg
Switzerland
9:00
Welcome and Introduction
9:15
Holistic CCI Approach
10:00
Regulatory Requirements:
- USP<1207>
- EU Annex 1
- ICH Q9
10:45
Coffee Break
11:00
Technology Overview
- Differential pressure
- High voltage
- Headspace analysis
- Tracer Gas / Mass Spectroscopy
12:00
Test Method Selection
- Understanding and application of relevant criteria
- Adapted feasibility approach
12:30
Lunch Break
13:45
Positive Controls
- Fundamentals
- Types
14:45
Method Development and Validation
- Process analysis
- FMEA
- Fixture qualification
- Method qualification
- Test method validation
15:30
Coffee Break
15:45
Manufacturing Control Strategy
- QC lab or 100% inspection
- Risk Assessment
- Sealing and Capping Forces
- Supply CCI in lieu of sterility on stability
- Chain and end-users exposures
- Visual Inspection
- Leak Testing
16:30
Wrap-up Day 1
17:00
End of Day 1
19:00
Networking Event
Day 2
Friday, 28 February 2020
Rigackerstrasse 11
5610 Wohlen
Switzerland
8:30
Recap Day 1 & Open Questions
9:00
Lab Session 1 (Hands-on)
Positive Controls
- Preparation
- Pros and Cons
- Verification with He Mass spec.
- Operation of lab equipment
- Considerations on installation sites
- Daily business considerations
- Method development
- Use of positive controls
10:45
Coffee Break
11:00
Hands-on Inline System
- System presentation and training
- Calibration procedures
- Validation runs
- Considerations on installation site
- Daily business considerations
12:15
Lunch Break
13:45
Lab Session 2 (Hands-on) (cont.)
- Operation of inline equipment
- Daily business considerations
- Considerations on installation site
- Method development
14:30
Coffee Break
14:45
Product Life Cycle
- Feasibility trials Implementation
- Day to day use
- Maintenance
- Change control
- New technologies
- Retrofits
- Line modifications
15:30
Wrap-up
16:00
End of Course
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Request InformationPLEASE 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.
Training Location Day 1
Mercure Lenzburg Krone
Kronenplatz 20
5600 Lenzburg
Switzerland
Training Location Day 2
Wilco AG
Rigackerstrasse 11
5610 Wohlen
Switzerland
Hotel Nearby
PDA Europe recommends the reservation at one of the following hotel.
The general terms of business are valid at the event hotels.
Mercure Lenzburg Krone
Kronenplatz 20
5600 Lenzburg
Switzerland
E-Mail
Tel: +41 62 886 65 65
The Mercure Hotel Krone is situated below Lenzburg Castle, on the edge of the Old Town. It offers traditional yet creative cuisine and free parking in the garage.Many cosy corners and the terrace provide for an intimate atmosphere in the charming restaurant.The rooms are spacious and feature a balcony. Rooms with connecting doors are available on request.