Quality & GMP Essentials for Regulatory Affairs/CMC
Managing the interface between Quality and Regulatory Affairs (RA)
- Fundamentals and background information
- International differences
- Sharpening understanding of the needs of the specialist departments involved
- Officially certified: ISO 9001+ 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 a pre-meeting.
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 a pre-meeting.
Quality & GMP Essentials for Regulatory Affairs/CMC: Managing the interface - knowledge of quality-relevant facts, GMP fundamentals, as well as understanding of the processes at the interface - including an Update on various guideline revisions, e.g. ICH Q1, M4Q(R2) and more - Qualify now!
Your speakers
What to Expect
- GMP Know-how: The essentials
- Specifications and impurities
- Change Control
- Stability testing/data
- Interface between Quality and Regulatory Affairs
- Validations
Who Should Attend
This seminar is aimed at employees in Regulatory Affairs/CMC.
Both, beginners and professionals from departments that work interdisciplinarily with the quality department will benefit from participation.
Prior knowledge of pharmaceutical quality is not required.
Objective of the Event
As an employee in Regulatory Affairs/CMC, do you want to master collaboration and communication at the interface with the quality department in a confident, efficient, and sustainable manner?
Essential for this is knowledge of quality-relevant facts, GMP fundamentals, as well as understanding of the processes at the interface.
After participating in the seminar, you will have gained insight into the requirements and workflows in the GMP-regulated area. Your understanding of the daily challenges faced by the quality department will be enhanced. You will know the data basis for your CMC documents and will have discussed approaches for transferring this knowledge to the regulatory area.
Realistic examples will strengthen the implementation of efficient communication at the interface between Quality and Regulatory Affairs/CMC in your daily work.
Your Benefit
What can you expect from the seminar content?
Here are some comments from former participants:
#"As hoped, the basic knowledge was taught and further deepened in a practical manner. In addition, our understanding of the various interfaces and the needs of the specialist departments involved was strengthened."
- "I will report on this to my team and recommend the event to others."
- "I gained a sound theoretical foundation and learned about international differences."
Programme
from 09:00 am - 05:00 pm CET
Raimund Brett and Dr Rainer Ilg
- Definition, objectives, guidelines
- GMP and PQS in practice
- Audits and inspektions
- Dokuments in the Quality/RA area
- PQR
- Supply chains: Oversight overview
- Interfaces in Manufacturing and Distribution of Pharmaceuticals
Dr Ralph Nussbaum
- ICH Q6A, Q6B, Pharmacopoeias
- ICH Q14: Analytical Lifecycle Management and ATP
- ICH Impurity Guidelines
- Mutagenic impurities and nitrosamines
- Specification limits
Raimund Brett
- Management of changes in the GMP-regulated environment
- Causes of changes
- Impact on and involvement of RA
Dr Ralph Nussbaum
- Conducting stability tests
- Shelf life, storage instructions
- Procedure for OOS results
Dr Rainer Ilg
- How does data get into the dossier?
- Who has which responsibility?
- Traceability
All speakers
- The basics
- Process and cleaning validation
- Method validation, including outlook on changes due to (Draft) ICH Q1 and (Draft) ICH M4Q(R2)
- Which validation data is relevant for regulatory documents?
Welcome, introduction, expectations
GMP Know-how
GMP Know-how
Raimund Brett and Dr Rainer Ilg
- Definition, objectives, guidelines
- GMP and PQS in practice
- Audits and inspektions
- Dokuments in the Quality/RA area
- PQR
- Supply chains: Oversight overview
- Interfaces in Manufacturing and Distribution of Pharmaceuticals
Bio break
Specifications and impurities
Specifications and impurities
Dr Ralph Nussbaum
- ICH Q6A, Q6B, Pharmacopoeias
- ICH Q14: Analytical Lifecycle Management and ATP
- ICH Impurity Guidelines
- Mutagenic impurities and nitrosamines
- Specification limits
Lunch break
Change Control
Change Control
Raimund Brett
- Management of changes in the GMP-regulated environment
- Causes of changes
- Impact on and involvement of RA
Stability testing/data
Stability testing/data
Dr Ralph Nussbaum
- Conducting stability tests
- Shelf life, storage instructions
- Procedure for OOS results
Bio break
Interface between Quality and Regulatory Affairs
Interface between Quality and Regulatory Affairs
Dr Rainer Ilg
- How does data get into the dossier?
- Who has which responsibility?
- Traceability
Validations
Validations
All speakers
- The basics
- Process and cleaning validation
- Method validation, including outlook on changes due to (Draft) ICH Q1 and (Draft) ICH M4Q(R2)
- Which validation data is relevant for regulatory documents?
Recap and outstanding questions
End of seminar
Downloads
brochure
All details and content at a glance.
Abbreviation List_Regulatory Affairs/CMC
Abbreviation List_Regulatory Affairs/CMC
HerunterladenWeitere Informationen
Qualification course CMC-Specialist in Regulatory Affairs
This seminar is the basic module of our qualification programme "CMC-Specialist".
The course concept:
- You attend our basic course "CMC Management in Regulatory Affairs"
- Afterwards you select and participate in 3 further seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
- You will receive structured further training and comprehensive knowledge on topics relating to CMC management
- You can specialise according to your main field of interest through the targeted selection of seminars
Please visit our webpage Website
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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.
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
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Further Information
Your Contact Person
We are happy to advise you personally and individually.

Dr. Birgit Wessels
Konferenzmanagerin Pharma & Healthcare
+49 6221 500-652
b.wessels@forum-institut.de





