2024-10-22 2024-10-22 , online online, 1,290 € plus tax Dr. Ralf Aubeck https://forum-institut.com/seminar/25042461-best-practice-project-management-in-gxp/referenten/25/25_04/25042461-online-seminar-pharma-project-management-in-gxp_aubeck-ralf.jpg Best practice: project management in GxP

Project management in GxP - Managing projects successfully and efficiently in a regulated environment!

Topics
  • Project management: the essentials
  • Working aids and tools
  • Regulatory expectations of projects in a regulated environment
  • Workshops/case studies - project scenarios in the GxP area: daily business, qualification and validation, change control/change management, international projects, psychological aspects


Who should attend
This workshop-orientated seminar is designed for specialists in the pharmaceutical and biotech industry who manage projects, e.g. relating to GMP upgrades, inspection readiness, qualification, validation or change control. All persons who are to take over these tasks in the future are also very welcome.
Aims and objectives
During the seminar, the requirements, hurdles and pitfalls of project management are presented in a practical way from a real world perspective. Several exercises and workshop units are designed to strengthen the ability to successfully manage projects. The highly regulated GxP sector requires numerous skills in addition to a theoretical basis. As a participant, you will learn about the various starting conditions and requirements for project management.
You will work with the expert to develop a project-appropriate approach based on realistic example scenarios (e.g. a GxP upgrade project, an extensive change control project, projects in an international and intercultural environment). Requirements for the role and the associated tasks and opportunities of the manager in the GxP area are analysed from various perspectives and action strategies are developed.
Your benefit

After attending the seminar, you will have a broad toolbox with tools for the successful management and realisation of projects of all kinds in a real world. The necessary knowledge and application of methods as well as solution concepts for the efficient management of projects are essential learning content. Using practical examples and best practices from the GxP sector, you will learn many different approaches. The empirical values for the realisation of successful projects are conveyed and developed interactively.

Online seminar Pharma - Project management in GxP

Best Practice:
Project management in GxP

- Online training -

Benefits
  • Practical knowledge for direct implementation
  • Know-how in terms of tools, soft skills/communication
  • Including case studies, examples, exercises Officially certified according to ISO 9001+21001

Webcode 25042461

Book now

JETZT Buchen
Speaker

Dr. Ralf Aubeck

gempex GmbH, Mannheim, GERMANY Principal Consultant / Quality GxP Pharma Senior & Executive

Dr Ralf Aubeck consults as Principal Consultant and Industry Certified GMP auditor worldwide for gempex GmbH for 5 years. He holds a doctorate in chemistry (Ludwig-Maximilians-University Munich). He has over 30 years of experience in responsible quality positions in German, American and Swiss industrial companies, with concrete experience from SME to corporate groups. Strategic and operative-pragmatic Quality Assurance including the function as technical responsible person in Switzerland, responsibility for sites in the regions of Asia and Europe are also part of this. International GxP compliance issues, U.S. FDA and EU inspection readiness are the focus of his current projects in the highly regulated life sciences industry and other GMP areas. He is familiar with the U.S. FDA topic through a high double-digit number of regulatory inspections with numerous FDA cGMP inspections. Experienced and current perspectives as auditee, coach, facilitator and translator before, during and after FDA Investigations. Ralf Aubeck is passionate about FDA and GxP.

Everything at a glance

Appointment

08/04/2025

08/04/2025

Period

09:00 am - 05:00 pm - online training
You may dial in 30 minutes before the training starts

09:00 am - 05:00 pm - online training
You may dial in 30 minutes before the training starts
Venue

online

online

Downloads
Fee

Event - 1,290 € plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Event - 1,290 € plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

Book now

Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

Project management in GxP - Managing projects successfully and efficiently in a regulated environment!

Topics

  • Project management: the essentials
  • Working aids and tools
  • Regulatory expectations of projects in a regulated environment
  • Workshops/case studies - project scenarios in the GxP area: daily business, qualification and validation, change control/change management, international projects, psychological aspects


Who should attend
This workshop-orientated seminar is designed for specialists in the pharmaceutical and biotech industry who manage projects, e.g. relating to GMP upgrades, inspection readiness, qualification, validation or change control. All persons who are to take over these tasks in the future are also very welcome.

Aims and objectives

During the seminar, the requirements, hurdles and pitfalls of project management are presented in a practical way from a real world perspective. Several exercises and workshop units are designed to strengthen the ability to successfully manage projects. The highly regulated GxP sector requires numerous skills in addition to a theoretical basis. As a participant, you will learn about the various starting conditions and requirements for project management.
You will work with the expert to develop a project-appropriate approach based on realistic example scenarios (e.g. a GxP upgrade project, an extensive change control project, projects in an international and intercultural environment). Requirements for the role and the associated tasks and opportunities of the manager in the GxP area are analysed from various perspectives and action strategies are developed.

Your benefit

After attending the seminar, you will have a broad toolbox with tools for the successful management and realisation of projects of all kinds in a real world. The necessary knowledge and application of methods as well as solution concepts for the efficient management of projects are essential learning content. Using practical examples and best practices from the GxP sector, you will learn many different approaches. The empirical values for the realisation of successful projects are conveyed and developed interactively.

Detailed programme

09:00 am - 05:00 pm - online training
You may dial in 30 minutes before the training starts

09:00 Welcome, introduction, expectations


09:15

Project management: the successful project - how does it work?
  • Definition: project, project management
  • Project management: basics, organisation, start, implementation, completion
  • Exercise on people and roles in the project

10:15

Practical experiences and tools
  • Stakeholder management
  • Documentation - too much - too little?!
  • IT tools
  • Problem solvers/empowerment tools
  • Escalation management & practical tips
  • Exercise on the tools (e.g. MS Project)

11:15

Regulatory expectations for projects in a regulated environment
  • Adequate and complete documentation: ALCOA in projects too?
  • From project plan to milestones to project completion: when does it make sense to inform or involve the authorities, when is it necessary?
  • Effectiveness check and performance review: securing results as the basis for valid procedures and processes

12:15

The project and the authority in the regulated GxP environment
  • Documentation: appropriate, inspection-proof, internal/external
The project plan, the right milestones, the conclusion and the lessons learnt from the project: involvement of the authority - national/international, when a must, when a can?
Pitfalls in projects: Antidotes and mitigation strategies
  • Exercise to involve the authorities

13:15 Lunch break


14:15

Workshop: Project case studies and scenarios in the GxP area
During the workshop you will work out approaches, advantages and disadvantages of concepts in projects.
The following case studies and thus the general range of activities of a project/quality manager or production manager (m/f) will be covered:
    • 1) The daily project reality
      2) National/international GxP projects
      3) Change management (change control)
      4) Qualification and validation
      5) Intercultural GxP projects
        • You are very welcome to submit your own concerns and specific (anonymised) case studies in advance.

16:45 Recap and outstanding questions


17:00 End of the online seminar


More informationen

Modular qualification course "Qualitätsmanager GMP"

This seminar can be taken as elective module as part of our qualification program to become a "Qualitätsmanager GMP" (most of the courses are available in German language).

The course concept:

  • You attend our basic course "GMP essentials in quality management"
  • Then you choose and take part in 3 further seminar modules (= 3 seminar days), which you put together individually from the course plan
  • You receive structured further training and comprehensive knowledge in GMP-/quality-relevant topics
  • You can specialise according to your main area of business activity by selecting the seminars specifically.

For more information, please visit our Website

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.

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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.

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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.

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