2024-04-23 2024-04-23 , online online, 1,190 € zzgl. MwSt. Dr. Cornelia Hunke https://forum-institut.de/seminar/24092481-gxp-regulated-archiving/referenten/24/24_09/24092481-online-training-pharma-gxp-regulated-archiving_hunke-cornelia.jpg GxP-Regulated Archiving

Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration of the archiving system into your daily work processes. The three experts will show you some practical approaches to typical pitfalls.

Topics
  • Compliance requirements within the GMP, GLP, and GCP framework in the pharmaceutical sector
  • Audit security, electronic archiving, outsourcing
  • Customized case study workshop: giving priority to your real-life cases
  • Audits and inspection of archiving systems


Who should attend
Professionals engaged in quality assurance, quality control/analytical laboratory, research and development, and clinical research - particularly those currently involved or aspiring to be involved in archiving processes within the GMP, GLP, or GCP environment - will derive valuable insights from participating in the seminar.
Aims and objectives
Archiving relevant documents in a GxP-compliant manner is anything but trivial. Carelessness and errors can quickly lead to complaints, deviations or official warning letters. Today, there are more detailed IT-regulations due to greater digitisation and more and better trained inspectors. This applies to digital archiving and corresponding cloud-based systems too.
The aim of the online seminar is to provide practical know-how for the GMP-, GLP- and GCP-compliant archiving of your documents as well as the effective and efficient integration of the archiving system into your daily work processes. Among other things, the experts will address the aspects of audit security, electronic archiving, outsourcing and common deficiencies during audits and inspections. You will apply the theoretical knowledge you have learnt directly in the practical workshop using realistic example scenarios.
Use this online seminar as a practical guide to minimise sources of error in future and to be optimally prepared for inspections by the authorities!
Your benefit

What can you expect and what will you take away?
Here is an excerpt of the feedback from last year's participants:

  • "The discussions were very good - it couldn't have been better!"
  • "You could get used to the atmosphere, very informative, especially with regard to IT matters: I feel informed."
  • "Always happy to come back."

Online training Pharma - GxP-regulated archiving

GxP-regulated archiving

- Online training -

Benefits
  • Know-how for the GMP, GLP and GCP environment
  • IT practical knowledge for direct implementation
  • Complete inspections by authorities gently
  • Officially certified according to ISO 9001 + 21001

Webcode 24092481

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

24/09/2024

24/09/2024

Zeitraum

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
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration of the archiving system into your daily work processes. The three experts will show you some practical approaches to typical pitfalls.

Topics

  • Compliance requirements within the GMP, GLP, and GCP framework in the pharmaceutical sector
  • Audit security, electronic archiving, outsourcing
  • Customized case study workshop: giving priority to your real-life cases
  • Audits and inspection of archiving systems


Who should attend
Professionals engaged in quality assurance, quality control/analytical laboratory, research and development, and clinical research - particularly those currently involved or aspiring to be involved in archiving processes within the GMP, GLP, or GCP environment - will derive valuable insights from participating in the seminar.

Aims and objectives

Archiving relevant documents in a GxP-compliant manner is anything but trivial. Carelessness and errors can quickly lead to complaints, deviations or official warning letters. Today, there are more detailed IT-regulations due to greater digitisation and more and better trained inspectors. This applies to digital archiving and corresponding cloud-based systems too.
The aim of the online seminar is to provide practical know-how for the GMP-, GLP- and GCP-compliant archiving of your documents as well as the effective and efficient integration of the archiving system into your daily work processes. Among other things, the experts will address the aspects of audit security, electronic archiving, outsourcing and common deficiencies during audits and inspections. You will apply the theoretical knowledge you have learnt directly in the practical workshop using realistic example scenarios.
Use this online seminar as a practical guide to minimise sources of error in future and to be optimally prepared for inspections by the authorities!

Your benefit

What can you expect and what will you take away?
Here is an excerpt of the feedback from last year's participants:

  • "The discussions were very good - it couldn't have been better!"
  • "You could get used to the atmosphere, very informative, especially with regard to IT matters: I feel informed."
  • "Always happy to come back."

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

Dr Timo Kretzschmar

Audit-proof archive: Only necessary for GLP?
  • In a nutshell: GxP archive requirements
  • What is an audit-proof archive? General overview
  • Data integrity in the archive
  • GxP mixed archive, procedures, general requirements
  • Archiving electronic data: Anticipating the future?
  • Destruction of archived data after the archiving retention period: A challenge?"
  • The archivist, archive training

10:00

Dr Cornelia Hunke and Dr Timo Kretzschmar

Why is archiving necessary?
  • National vs. international requirements/expectations
  • Different requirements in the GMP/GLP and GCP environment
  • Roles and Responsibilities
  • Data protection requirements vs. GxP requirements
  • Paper-based or electronic?
  • The original-copy dilemma for e-archives or hybrid archives and special pitfalls (practical examples)

11:00 Bio break


11:15

Dr Ronald Schmidt

Best practice: Electronic archiving
  • Archiving database content and e-documents
  • Replacement scanning (Verified Copy)
  • The role of the e-signature (implementation in the EU)
  • Ensuring the responsibility of the archivist
  • Delegation of archiving tasks to IT
  • Requirements and difference between Disaster Recovery, Backup and Archiving
  • Archiving vs. Data Lake
  • Validation of the archiving process incl. verification of the archived material
  • Suitable data carriers and systems suitable for archiving ("WORM")
  • Suitable and unsuitable data formats for archiving
  • Implementation of the requirements in practice

12:30 Lunch break


13:30

Dr Timo Kretzschmar

Outsourcing of archiving
  • Finding the right provider
  • Drafting contracts and liability issues
  • Responsibilities in outsourcing
  • Quality assurance measures
  • GMD/GDP/GLP certification of electronic archives/cloud providers
  • Pros and cons - accessibility?
  • Where is my data? What information is expected for documentation or during inspections?

14:30 Bio break


14:45

Dr Timo Kretzschmar

Workshop/Case study

15:45

Dr Cornelia Hunke

Audits and inspection of archiving systems
  • What is the focus of the auditor/inspector?
  • Consequences of loss/non-retrievability of documents, appropriate measures to prevent serious consequences
  • Shortcomings in archiving GxP-relevant data
  • Flaws in typical archiving procedures

16:45 Audits and inspection of archiving systems


17:00 End of the seminar


Unser Partner

DiQualis Deutschland GmbH

DiQualis berät, begleitet und schult Unternehmen aus unter anderem den Branchen Pharma, Chemie, Gesundheit und Umwelt bei Projekten des Qualitätsmanagements, der IT-Compliance, der Datenintegrität und im Bereich Corporate Social Responsibility.



More information

Modular qualification course IT-Quality-Specialist

This seminar can be taken as elective module as part of our qualification program to become an IT-Quality-Specialist (German-speaking only).

The course concept:

  • You attend our basic course "Basiswissen IT-Quality in GxP"
  • 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 IT 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

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

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.

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.

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality