Mastering ICH Quality Guidelines: From Development to Lifecycle Management
Quality by Design and strategies for a successful ICH Q12 implementation
- ICH-guidelines Q8 to Q12 - Interfaces
- Strategies for ICH Q12 implementation
- Awareness for QbD opportunities
- Officially certified according to ISO 9001 and ISO 21001
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
9:00 am - 5:00 pm Online training
You may dial in 30 minutes before the lecture starts
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
9:00 am - 5:00 pm Online training
You may dial in 30 minutes before the lecture starts
To make the most of ICH Q12 opportunities, you 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 the processes from development to lifecycle management and especially QbD.
Your speakers
Dr. Oliver Brehm
Consultant
Dr Brehm was employed in the Pharmaceuticals and Consumer Health divisions at Bayer Group for 30 years. He worked as a production manager, was involved in drug development and approval. He…
Your speaker
Dr. Oliver Brehm
Consultant
Dr Brehm was employed in the Pharmaceuticals and Consumer Health divisions at Bayer Group for 30 years. He worked as a production manager, was involved in drug development and approval. He was responsible for global quality management for both Pharmaceuticals and ConsumerHealth in Germany and abroad. Until 2024 he was Chief Quality Officer of Bayer AG and now works as an independent consultant in the areas of GxP, Quality Management and TechOps Pharma.
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI),
Langen
Dr Gross has extensive experience in molecular and cell biology. In his current position, he is involved in the assessment of the quality and preclinical issues for…
Your speaker
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI),
Langen
Dr Gross has extensive experience in molecular and cell biology. In his current position, he is involved in the assessment of the quality and preclinical issues for marketing authorisation applications, scientific advices and clinical trial applications.
Dr. Helmut Vigenschow
ViPharmaService,
Burgrieden
Independent Consultant
Dr Vigenschow worked for Merckle/ratiopharm for 30 years in leading positions, including in the areas of project management, regulatory affairs,…
Your speaker
Dr. Helmut Vigenschow
ViPharmaService,
Burgrieden
Independent Consultant
Dr Vigenschow worked for Merckle/ratiopharm for 30 years in leading positions, including in the areas of project management, regulatory affairs, pharmaceutical development, quality assurance and quality control.
Dr Vigenschow has been working as an independent consultant for several years now.
What to Expect
- From QbD (ICH Q8) to designed lifecycle management (ICH Q12): How to make the most of ICH Q12 opportunities
- Special considerations and challenges for biologics
- ICH Q8 and ICH Q11: Mastering QbD concepts
- ICH Q9 and Q10: "Tools" to implement QbD
- ICH Q12: Interpretation and implementation
Who Should Attend
Any professional in the healthcare industry that is involved in pharmaceutical development and integrated lifecycle management processes - handling regulatory and quality related aspects during the product lifecycle and seeking to keep the pace with latest regulatory strategies - will profit from this online training course.
Objective of the Event
Are you involved in product lifecycle management processes? Stop asking if Quality by Design is mandatory or needed! Our three experts will sensitise you not to underestimate any longer what you can in fact get from it.
To make the most of ICH Q12 opportunities you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. It's absolutely critical that you understand the need of mastering the different Quality by Design (QbD) options and that you realise their implications.
Our experts will go through each guideline with focus on ICH Q8 (drug product) and ICH Q11 (drug substance). They will point out the specific challenges with interpretation and implementation and the relation between all guidelines.
In the end you will be trained in a more conceptional way on the desired outcome of mastering QbD to make the most of ICH Q12.
Your Benefit
After participating in this seminar you will be aware of the relation between the guidelines ICH Q8 to ICH Q12.
This will enable you to recognise the opportunities of ICH Q12 and to profitably put the requirements of the guideline into practice.
Programme
9:00 am - 5:00 pm Online training
You may dial in 30 minutes before the session
09:00
09:15
Dr Steffen Groß
- From product development to lifecycle management
- 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
10:20
10:30
Dr Oliver Brehm
- Content in Module 3, Section 3.2.P.2
- Quality by Design: Mastering the different concepts to make the most of ICH Q12 options
- Interfaces Q9, Q10, Q&A Step4
- Interface Q12 - focus established conditions, relation Q14 - Best practice
12:30
13:30
Dr Helmut Vigenschow
- Principles and tools for quality risk management
- Systems for appropriate quality management covering developmentand manucfacturing stages
- Tools to implement QbD
- Interfaces Q8, Q9, Q10 and Q11, Q&A Step 4
- Interface Q12 - Best practice
15:00
Dr Helmut Vigenschow
- 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
16:30
Dr Steffen Groß, Dr Oliver Brehm
- Correct interpretation of the ICH Q12
- 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
Opening and introduction round
09:15
Integrated product development
Integrated product development
Dr Steffen Groß
- From product development to lifecycle management
- Core guideline ICH Q12
- Challenges with the interpretation
- Challenges with the implementation
- The factor to success: Integrating related ICH quality guidelines
Special considerations and challenges for biologics
Coffee break
10:30
ICH Q8: Pharmaceutical development - Drug product
ICH Q8: Pharmaceutical development - Drug product
Dr Oliver Brehm
- Content in Module 3, Section 3.2.P.2
- Quality by Design: Mastering the different concepts to make the most of ICH Q12 options
- Interfaces Q9, Q10, Q&A Step4
- Interface Q12 - focus established conditions, relation Q14 - Best practice
Lunch break
13:30
ICH Q9: Quality risk management, ICH Q10: Pharmaceutical Quality System
ICH Q9: Quality risk management, ICH Q10: Pharmaceutical Quality System
Dr Helmut Vigenschow
- Principles and tools for quality risk management
- Systems for appropriate quality management covering developmentand manucfacturing stages
- Tools to implement QbD
- Interfaces Q8, Q9, Q10 and Q11, Q&A Step 4
- Interface Q12 - Best practice
15:00
ICH Q11: Development and manufacture of drug substance
ICH Q11: Development and manufacture of drug substance
Dr Helmut Vigenschow
- 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
Coffee break
16:30
ICH Q12: Lifecycle management
ICH Q12: Lifecycle management
Dr Steffen Groß, Dr Oliver Brehm
- Correct interpretation of the ICH Q12
- 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)
End of the training
Unser Partner
Downloads
Request the documents using our form.
Brochure
Abbreviation list_Drug Regulatory Affairs and CMC
Weitere Informationen
Modular qualification training course
This course can be choosen as elective module within the modular qualification training course "CMC-Specialist in Regulatory Affairs".
The concept:
- First you visit the mandatory module "Der CMC-Manager in Regulatory Affairs"
- Further you choose another three elective modules (= three training days) dealing with CMC related topics from our portfolio
- Thus you receive a structured training in CMC/Regulatory Affairs topics
- Thus you are able to qualify yourself individually according to your focus of activities
Please visit our webpage Website
Benefits of a FORUM Institut training course
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
- Live and interactive learning on our Learning Space training platform
- A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
- Easy surveys with Slido
- ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
- A central repository for documents and media
- Other services and apps such as Padlet and Mentimeter available directly on the platform
- The perfect marriage of teaching methods and technology
- High level of interactivity with plenty of opportunity for questions
- Continuous support throughout the event to ensure the most effective learning
- Free technical pre-meeting to start off your training on the right foot
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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Further Information
In-house seminars
Our programmes are also available for in-house training. Just contact us!
In-house seminars
Our programmes are also available for in-house training. Just contact us!
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de