2024-04-12 2024-04-12 , online online, 1,190 € plus tax Dr. Steffen Groß https://www.forum-institut.com/seminar/24112457-mastering-ich-quality-guidelines-from-development-to-lifecycle-management/referenten/24/24_11/24112457-pharma-course-mastering-ich-quality-guidelines-focus-ich-q12_gross-steffen.jpg Mastering ICH Quality Guidelines: From Development to Lifecycle Management

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.

Topics
  • 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.
Aims and objectives
You are 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.

Pharma course - Mastering ICH Quality Guidelines - Focus: ICH Q12

Mastering ICH Quality Guidelines:
From Development to Lifecycle Management

- Online training -

Benefits
  • ICH-guidelines Q8 to Q12 - Interfaces
  • Strategies for ICH Q12 implementation
  • Awareness for QbD opportunities
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24112457

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

28/11/2024

28/11/2024

Period

9:00 am - 5:00 pm online seminar
You may dial in 30 minutes before the training starts

9:00 am - 5:00 pm online seminar
You may dial in 30 minutes before the training starts
Venue

online

online

Downloads
Fee
Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

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.

Topics

  • 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.

Aims and objectives

You are 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.

Detailed programme

9:00 am - 5:00 pm online seminar
You may dial in 30 minutes before the training starts

09:00 Opening and introduction round


09:15

Dr Steffen Groß

Integrated product development
  • 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

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 most of ICH Q12 options
  • 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
  • Principles and tools for quality risk management
  • Systems for appropriate quality management covering development and 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 of 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 and André Mota

ICH Q12: Lifecycle management
  • 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 End of the training


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Seit 2000 bieten wir Expertenwissen zu verschiedenen Rechtsthemen in englischer und deutscher Sprache an. Zu unseren Kernkompetenzen gehören u.a. das Stoff- und Chemikalienrecht sowie das Pharmarecht.

More information

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

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