2021-11-11 2021-11-11 , Online Online, 1.090,- € zzgl. MwSt. Dr. Steffen Groß https://www.forum-institut.de/seminar/2111970-integrated-product-development/referenten/21/21_11/2111970-online-training-pharma-integrated-product-development_gross-steffen.jpg Integrated product development

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.

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
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.
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.

Online seminar - integrated product developement

Integrated product development

- Online training -

Benefits
  • Excellent speakers, first-hand information
  • This expertise will benefit your company
  • Pose your questions in advance
  • Online format:Modern, interactive
  • We are following the IMI quality criteria

Webcode 2111970

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JETZT Buchen

Referenten


Alles auf einen Blick

Termin

11.11.2021

11.11.2021

Zeitraum

9:00 am - 5:00 pm seminar

9:00 am - 5:00 pm seminar
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

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

Details

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.

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
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.

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.

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 most of 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/tools for a more predictable and efficient handling of post-approval CMC changes
  • Area of conflict: Implementation status (established conditions, classificationof variations)

17:00 End of the training


Kooperationspartner

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

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

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

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

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Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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