2024-10-13 2024-10-13 , online online, 1,990 € zzgl. MwSt. Dr. Michael Bock https://www.forum-institut.de/seminar/25022460-gmp-essentials-for-quality-management/referenten/25/25_02/25022460-online-seminar-pharma-gmp-essentials-for-quality-management_bock-michael.jpg GMP essentials for quality management

Will you be involved in the implementation and sustainable maintenance of the quality management system in your pharmaceutical company in the future? Our experts will provide you with the essential understanding of the subsystem of good manufacturing practice in this seminar. Also suitable as an update for experienced specialists.

Topics
  • GMP terms and the most important regulations
  • Requirements: production, employees, hygiene, data
  • Quality risk management
  • Analytics, deviation handling, change control and CAPA as important elements of the quality assurance system
  • Audits and inspections: planning, implementation, follow-up
  • Requirements for packaging, storage, transportation


Who should attend
This seminar is aimed at specialists in the pharmaceutical industry who will be responsible for the implementation and improvement of the GMP QA System in the future. The course is also suitable as an update for experienced specialists.
Aims and objectives
During this seminar, our experts will provide you with the elemental know-how to understand and implement GMP measures.

After having participated in the course, you will be familiar with the requirements of the GMP compliance system for production, staff/employees, hygiene and data handling. You will be able to comply with the requirements for GMP-compatible documentation and support the preparation and realization of audits and inspections.
The importance of risk management, deviation handling and change control has been deepened. Furthermore, you will be familiar with the requirements for GMP-compatible packaging, storage and logistics.
Your benefit

After having attended the seminar, you will be equipped with the essential know-how on the requirements of a quality management system and the GMP quality assurance system. You will know how to control processes in a GMP-compliant manner.

Do you want to professionalise your expertise? Then you are invited to attend our seminar "GMP Aufbauwissen für Qualitätsmanager" (25012460).

Online seminar - GMP essentials for quality management

GMP essentials for quality management

- Online training -

Benefits
  • The essentials for beginners
  • Including practical examples and quizzes
  • Well prepared for audits and inspections
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25022460

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

18-19/02/2025

18-19/02/2025

Zeitraum

On both days from 9:00 am till 05:00 pm - online training
You may dial in 30 minutes before the training starts

On both days from 9:00 am till 05:00 pm - online training
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

Will you be involved in the implementation and sustainable maintenance of the quality management system in your pharmaceutical company in the future? Our experts will provide you with the essential understanding of the subsystem of good manufacturing practice in this seminar. Also suitable as an update for experienced specialists.

Topics

  • GMP terms and the most important regulations
  • Requirements: production, employees, hygiene, data
  • Quality risk management
  • Analytics, deviation handling, change control and CAPA as important elements of the quality assurance system
  • Audits and inspections: planning, implementation, follow-up
  • Requirements for packaging, storage, transportation


Who should attend
This seminar is aimed at specialists in the pharmaceutical industry who will be responsible for the implementation and improvement of the GMP QA System in the future. The course is also suitable as an update for experienced specialists.

Aims and objectives

During this seminar, our experts will provide you with the elemental know-how to understand and implement GMP measures.

After having participated in the course, you will be familiar with the requirements of the GMP compliance system for production, staff/employees, hygiene and data handling. You will be able to comply with the requirements for GMP-compatible documentation and support the preparation and realization of audits and inspections.
The importance of risk management, deviation handling and change control has been deepened. Furthermore, you will be familiar with the requirements for GMP-compatible packaging, storage and logistics.

Your benefit

After having attended the seminar, you will be equipped with the essential know-how on the requirements of a quality management system and the GMP quality assurance system. You will know how to control processes in a GMP-compliant manner.

Do you want to professionalise your expertise? Then you are invited to attend our seminar "GMP Aufbauwissen für Qualitätsmanager" (25012460).

Detailed programme

On both days from 9:00 am till 05:00 pm - online training
You may dial in 30 minutes before the training starts

09:15

Dr Eberhard Meyle

Basics and regulations
  • Quality management: the basics
  • GMP: philosophy, goals, and basics
  • Relevant regulations and guidelines, authorities and organisations
  • Implementation of an effective and efficient quality management system

10:45 Bio break


11:00

Dr Michael Bock

GMP-compliant production
  • Manufacturing process development and transfer to production
  • Requirements for facilities, equipment, processes, and documents
  • Qualification, validation, calibration
  • Tasks and responsibilities
  • Planning, documentation and evaluation: effort vs benefit

12:30 Lunch break


13:30

Dr Michael Bock

Documentation and data management
  • Types of documentation
  • Tasks and responsibilities
  • The Product Quality Review (PQR)
  • Validation report, logbook, calibration, labeling
  • Consequences of non-compliant documentation
  • Requirements: data archiving
  • Data integrity - what to consider?

14:45

Dr Michael Bock

Quality control and analytics
  • Requirements for analytical laboratory
  • Method development, validation, verification, transfer
  • Analytical KPI
  • Sample collection and storage
  • Contracting of laboratories

15:45 Bio break


16:00

Dr Eberhard Meyle

Documentation and data management
  • Types of documentation
  • Tasks and responsibilities
  • The Product Quality Review (PQR)
  • Validation report, logbook, calibration, labeling
  • Consequences of non-compliant documentation
  • Requirements: data archiving
  • Data integrity: what to consider?

17:00 Recap and remaining questions


09:00

Dr Michael Bock, Dr Eberhard Meyle

Quality management
  • ICH Q9: modern risk management
  • Risks in pharmaceutical production
  • Appropriate methods and tools

10:30 Bio break


10:45

Dr Eberhard Meyle

Deviations, change control, CAPA
  • How to deal with deviations
When does the error event lead to a CAPA process?
Change management
  • Roles and responsibilities

12:00 Lunch break


13:00

Dr Michael Bock

Audits, inspections and suppliers
  • Regulatory principles
  • Country-specific requirements
  • Essentials for planning, conducting and follow-up of audits
What an inspector looks for
  • Typical findings
  • Contract manufacturing and suppliers: contracts, QAA, responsibilities

14:30 Bio break


14:45

Dr Michael Bock

Requirements for packaging, storage and transport
  • Regulatory principles
Guaranteeing quality during the packaging process
  • Logistic and supply chain risk management

16:00

Dr Eberhard Meyle

Complaint management and product recalls
  • Dealing with product complaints
Customer and supplier complaints
Organisation of recalls
  • Tasks and responsibilities
  • Practical examples

16:45 Recap and remaining questions


17:00 End of the seminar


More information

In-house seminars: Advanced training tailor-made!

You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!

We also offer this seminar as an in-house seminar.

Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.

We will be happy to send you a non-binding offer.

Qualification course "GMP quality manager"

This seminar can be chosen as an optional module as part of our GMP Quality Manager qualification course.

The course concept:

  • You attend our basic course "GMP essentials for quality management".
Afterwards you take part in 3 further seminar modules (= 3 seminar days), which you can chose individually from the course plan.
You will receive structured training and comprehensive knowledge on GMP/QM topics.
  • The targeted selection of seminars allows you to specialise according to your main area of activity.

Please visit our webpage Website

Please note that the majority of courses is carried out in german language.

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.

This distinguishes our events

of 5 stars of all ratings from 2023

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