Integrated Product Development
Seminar
Online
Beschreibung
-
Kursart
Seminar
-
Methodik
Online
To make the most of ICH Q12 opportunities you as a lifecycle manager have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering QbD.
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Risk Management
- Interface
- Management
Inhalte
Detailed programme
9:00 am - 5:00 pm seminar
09:00 Opening and introduction round
09:15
Dr Steffen Groß
Integrated Product Development
- Core guideline ICH Q12
- Challenges with the interpretation
- Challenges with the implementation
- The factor to success: Integrating related ICH quality guidelines
09:45
Dr Steffen Groß
Special considerations and challenges for biologics
10:20 Coffee break
10:30
André Mota
ICH Q8: Pharmaceutical Development - Drug Product
- Content in Module 3, Section 3.2.P.2
- Quality by Design: Mastering the different concepts to make the mostof ICH Q12 opportunities
- Interfaces Q9, Q10, Q&A Step4
- Interface Q12: Focus established conditions, relation Q14 - Best Practice
12:30 Lunch break
13:30
Dr Helmut Vigenschow
ICH Q9: Quality Risk Management, ICH Q10: Pharmaceutical Quality System
- Risk management: Principles, tools
- Quality management systems covering development, manucfacturing stages
- Tools to implement QbD
- Interfaces Q8, Q9, Q10 and Q11,Q&A Step4
- Interface Q12: Best Practice
15:00
Dr Helmut Vigenschow
ICH Q11: Development and Manufacture - Drug Substance
- Developing and understanding the manufacturing process
- Implementing specific aspects, e.g.activities to reduce impurities
- Content in Module 3,Sections 3.2.S.2.2 - 2.6
- Q&As Step 4 (focus starting materials)
- Interface Q12 - Best Practice
16:15 Coffee break
16:30
Dr Steffen Groß
ICH Q12: Lifecycle Management
- Correct interpretation of the guideline
- Methods and tools for a more predictable and efficient handling of post-approval CMC changes
- Area of conflict: Implementation status (established conditions, classification of variations)
17:00 End of the training
Detailed programme
9:00 am - 5:00 pm seminar
09:00 Opening and introduction round
09:15
Dr Steffen Groß
Integrated Product Development
- Core guideline ICH Q12
- Challenges with the interpretation
- Challenges with the implementation
- The factor to success: Integrating related ICH quality guidelines
09:45
Dr Steffen Groß
Special considerations and challenges for biologics
10:20 Coffee break
10:30
André Mota
ICH Q8: Pharmaceutical Development - Drug Product
- Content in Module 3, Section 3.2.P.2
- Quality by Design: Mastering the different concepts to make the mostof ICH Q12 opportunities
- Interfaces Q9, Q10, Q&A Step4
- Interface Q12: Focus established conditions, relation Q14 - Best Practice
12:30 Lunch break
13:30
Dr Helmut Vigenschow
ICH Q9: Quality Risk Management, ICH Q10: Pharmaceutical Quality System
- Risk management: Principles, tools
- Quality management systems covering development, manucfacturing stages
- Tools to implement QbD
- Interfaces Q8, Q9, Q10 and Q11,Q&A Step4
- Interface Q12: Best Practice
15:00
Dr Helmut Vigenschow
ICH Q11: Development and Manufacture - Drug Substance
- Developing and understanding the manufacturing process
- Implementing specific aspects, e.g.activities to reduce impurities
- Content in Module 3,Sections 3.2.S.2.2 - 2.6
- Q&As Step 4 (focus starting materials)
- Interface Q12 - Best Practice
...
Integrated Product Development