Container Closure Integrity Testing – Basic Course - Fall Edition
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Individual Registration
Group Registration
This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to applying these testing methods for CCI verification throughout drug product lifecycle. The course will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this course, participants gain critical problem solving skillsthrough:
- interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
- hands-on testing training on the newest innovations and state-of-the-art instruments
- real-world case studies.
This course utilizes lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing, with focus on achieving the following key objectives:
- Understanding up-to-date regulatory and pharmacopeia requirements on CCI.
- Defining CCI requirements for various container and drug product types using a risk-based approach.
- Explaining working principles of various CCI testing techniques and their practical applications, with focus on deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laserbased gas headspace analysis, mass extraction leak test.
- Selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles.
- Defining CCI testing method development and validation approach and best practices.
- Avoiding common issues and pitfalls in CCI testing applications
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Standard Pricing
Standard 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. [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.
Day 1
Thursday, 24 October 2019
9:00
Welcome and Introduction
Learning objectives and benchmarking questionnaire
9:15
Regulatory Requirements:
CCI Introduction, Regulatory Requirements, and Industry Trends
9:45
CCI Assurance throughout Product Lifecycle
- CCI Assurance throughout Product Lifecycle
- Testing requirement definition – risk based approach
- CCI Profile & Testing strategy development
10:30
Coffee Break
11:00
CCI Test Methods: Fundamentals
- CCI defects and commonly used positive controls
- Evolution of CCI testing technology: liquid flow, gas flow, electron flow (electric current)
11:30
Methodologies for Sizing CCI Defects Using Gas Flow Dynamics
12:00
Lunch Break
13:00
CCI Test Methods: Overview
- Deterministic vs probabilistic definitions
- Physicochemical methods vs microbiological methods: differences and correlations
- Microbial and Dye Ingress Testing Basics
13:30
CCI Testing Technologies
- Vacuum and pressure decay
- Mass Extraction
- Headspace analysis
- Tracer gas (helium leak detection)
- HVLD - PTI
14:30
Coffee Break
15:00
Application Case Studies (Part 1)(continued)
- Tracer gas (helium leak detection)
- Vacuum and pressure decay
15:40
Hands-on Training
- All instrument stations
- HVLD station
- Vacuum decay
- Headspace
- Helium leak detection
- Mass extraction
- AMI Optical Emission Spectroscopy
16:20
Day 1 Review, Q&A
17:00
End of Day 1
Day 2
Friday, 25 October 2019
8:30
Welcome
8:40
Application Case Studies – Cont.
- Mass Extraction
- AMI Optical emission spectroscopy for CCI testing
9:20
Hands-on Training
10:10
Coffee Break
10:40
Application Case Studies – Cont.
- Headspace analysis
- HVLD
11:20
Hands-on Training – Cont.
12:00
Lunch Break
13:00
Development and Validation of Integrity Test Methods
- Method development best practices
- Method validation strategy
- Pitfalls and solutions
13:40
Approaches to CCI Testing Method Selection
Method selection considerations
Introduce Group Exercise:
Product life cycle testing and method selection
14:30
Coffee Break
15:00
Group Exercise - Breakout
15:30
Group Exercise - Presentations & Discussion
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.
The Swedish Exhibition & Congress Centre Gothia Towers Hotel
Mässans Gata 24Gothenburg, Sweden , Sweden
The Swedish Exhibition & Congress Centre Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg, Sweden
optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting the conference hotel.