2022-11-18 2022-11-18 , online online, 1.090,- € plus tax Dr. Hans-Georg Eckert https://www.forum-institut.com/seminar/22112462-atmps-quality-and-risk-management/referenten/22/22_11/22112462-online-course-pharma-atmps-quality-and-risk-management_eckert-hans-georg.jpg ATMPs: Quality and risk management

ATMPs: Quality and risk management - Five experts from industry, consulting and authority will address the specifics of ATMPs/gene therapeutics in terms of GMP, quality assurance and risk management.

Topics
  • Regulatory overview on ATMPs
  • GMP and quality compliance
  • Quality: Risk-based approach for ATMP manufacturers
  • Workshop: Cleaning and disinfection program (risk-based approach)
  • ATMP GMP inspection experience
  • ATMPs: Challenges during development (case study)
Aims and objectives
This seminar focuses on quality aspects during the development and production of ATMPs/genetherapeutics.
    • Five experts from industry, consulting and authority will address the specifics of ATMPs in terms of GMP, quality assurance and risk management. At the end of the seminar, you will know how to avoid contamination, where deficiencies or anomalies often occur during inspections, and how to continuously ensure GMP compliance.
Who should attend

This seminar is aimed at specialists and managers who develop and produce ATMPs/gene therapeutics. In particular, employees of GMP-relevant areas will benefit from the exchange with the experts.

Online course Pharma - ATMPs: Quality and risk management

ATMPs: Quality and risk management

- Online training -

Benefits
  • First-hand information
  • In-depth know-how from different prespectives
  • Submit your questions prior to the course
  • Online format without travel expenses
  • We are following the IMI quality criteria

Webcode 22112462

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

18.11.2022

18.11.2022

Period

09:00 am - 5:30 pm - Online seminarY...

09:00 am - 5:30 pm - Online seminar
You may dial in 30 minutes before the training starts.
Venue

online

online

Downloads
Fee
Your contact person

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

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

Details

ATMPs: Quality and risk management - Five experts from industry, consulting and authority will address the specifics of ATMPs/gene therapeutics in terms of GMP, quality assurance and risk management.

Topics
  • Regulatory overview on ATMPs
  • GMP and quality compliance
  • Quality: Risk-based approach for ATMP manufacturers
  • Workshop: Cleaning and disinfection program (risk-based approach)
  • ATMP GMP inspection experience
  • ATMPs: Challenges during development (case study)
Aims and objectives

This seminar focuses on quality aspects during the development and production of ATMPs/genetherapeutics.

    • Five experts from industry, consulting and authority will address the specifics of ATMPs in terms of GMP, quality assurance and risk management. At the end of the seminar, you will know how to avoid contamination, where deficiencies or anomalies often occur during inspections, and how to continuously ensure GMP compliance.

Who should attend

This seminar is aimed at specialists and managers who develop and produce ATMPs/gene therapeutics. In particular, employees of GMP-relevant areas will benefit from the exchange with the experts.

Detailed programme

09:00 am - 5:30 pm - Online seminar
You may dial in 30 minutes before the training starts.

Opening and introduction round


Dr Hiltrud Horn

Regulatory overview on ATMPs
  • ATMPs in a GMP and regulatory environment
  • Which GMP-aspects should you consider?
  • What is essential for you for clinical trials?
  • Typical challenges

Coffee break


Nicolina Renkvist

GMP and quality compliance
  • Quality by design approach
  • Starting and raw materials
  • Transition from R&D to GMP compliance
  • QMS system implementation
  • Steps of lifecycle apprach and requirements for the different product lifecycle phases
  • Complexity of ATMPs

Lunch break


Dr Hans-Georg Eckert

Quality: Risk-based approach for ATMP manufacturers
  • Multi-product facility: Risk mitigation measures
  • Avoiding cross contamination
  • Specific considerations for/during process development and process validation

Walid El Azab

Workshop: Cleaning and disinfection program (risk-based approach)
  • Identify the source of contamiantion
  • Assess the risk of contamination
  • Identify the measure needed to reduce the risk of contamination
  • Define the cleaning and disinfection program such as frequency, cleaning prior to disinfection, residue removal, type of disinfecting agent to use and frequency of rotation.

Coffee break


Dr Hiltrud Horn

ATMPs: Challenges during development (case study)
  • Points to consider for a successful development of ATMPs
  • Interaction with authorities (meetings/inspections)

Summary and outstanding questions


End of online training


More information

How does an online seminar work?

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.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • 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

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

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