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

Buchungsdetails

Online-Seminar

Ab 1.290,00 € zzgl. MwSt.
Leistungen & Ablauf

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

Raimund Brett

Raimund Brett

gempex GmbH,
Mannheim, GERMANY

Principal Consultant
Raimund Brett is a certified industrial master craftsman specialising in pharmacy (IHK) and has worked in the manufacture of sterile drugs and the…

Dr. Rainer Ilg

Dr. Rainer Ilg

Boehringer Ingelheim Pharma GmbH & Co. KG,
Ingelheim, GERMANY

Senior Associate Director, Global Technical Regulatory Affairs
Dr Ilg has been working at Boehringer Ingelheim since 2007. He spent his first…

Dr. Ralph Nussbaum

Dr. Ralph Nussbaum

betapharm Arzneimittel GmbH,
Augsburg, GERMANY

Qualified Person
Dr Nussbaum has been Qualified Person at betapharm Pharmaceuticals since March 2026.
Over the past 30 years, he has held senior QC/QA…

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

Welcome, introduction, expectations

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
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
Raimund Brett
  • Management of changes in the GMP-regulated environment
  • Causes of changes
  • Impact on and involvement of RA

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
Dr Rainer Ilg
  • How does data get into the dossier?
  • Who has which responsibility?
  • Traceability

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

Welcome, introduction, expectations

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

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

Raimund Brett

  • Management of changes in the GMP-regulated environment
  • Causes of changes
  • Impact on and involvement of RA

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

Dr Rainer Ilg

  • How does data get into the dossier?
  • Who has which responsibility?
  • Traceability

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

Weitere 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


In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

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Further Information

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Our modular qualification courses: top seminars, flexible selection and cost savings.

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Our rating in 2025

Our rating in 2025

More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.

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Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Dr. Birgit Wessels

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