The world-wide standard and guidance ISPE GAMP®5 – first edition 2008 - was updated in 2022. The overall concept, approach, and key concepts remained unchanged from the first edition. The content of the guide was updated to reflect the increased application of information technology and cloud service providers (CSPs), evolving agile approaches to software development including incremental and iterative best practice standards, and increased use of validation tools and test automation.

In addition, new and upcoming technological areas such as artificial intelligence and machine learning (AI/ML) has been included. The major importance of process mapping, data flow diagrams (data integrity) and so called critical thinking approaches should supplement quality risk-based approaches and reduce primarily compliance-driven approaches. 

Furthermore ISPE GAMP 5 Second Edition refers to the whole set of GAMP Good Practice Guides (e.g. Enabling Innovation, Operations, Testing) and other applicable regulations and standards (e.g. ISO 20000). The training will cover all relevant aspects and given references.       

MAIN TOPICS

- ISPE GAMP®5 – Second Edition – Changes to First Edition and History

- ISPE GAMP®5 – Second Edition – Overview, structure and new approaches (2022) – how to read GAMP?

- ISPE GAMP®5 – Good Practice Guide - Enabling Innovation (2021)

- US-FDA - Computer Software Assurance (CSA)

- Updates and news (EMA - concept paper – GMP EudraLex Vol. 4 - Annex 11)

We will have a one hour break from 12.00 until 13.00 o'clock

WHAT TO LEARN FROM EXPERTS

- How to profit from ISPE GAMP second edition?

- How to read and understand the new concept?

- What comes next for e-Validation?

- How to manage changes and enable innovation?

- How to qualify and validate IT and applications?

- How to use new technology and tools, e.g. e-Validation? 

PARTICIPANTS

This training is focused on pharmaceuticle companies, especially on employees from following departments:

- Validation/Qualifying

- GM/DP Compliance

- Production/Quality Control

- Quality

- Management

Employees from other departments are very welcome.

FEE

399,- € for attending the live webinar incl. slides and attendance comfirmation (per person an additional tax)

You don't have time at this date?

In this case you may book the webinar recording (for your service for four weeks), which is including slides and attendance confirmation or available at any requested time.

The fee for the recording is 345,- € (per person an additional tax).

INSTRUCTOR

Markus Roemer

Geschäftsführer der comes compliance services

Herr Roemer schloss sein Studium an der Hochschule Ravensburg als Diplomingenieur ab. Er verfügt über weitreichende Erfahrung im GxP- und Auditbereich, insbesonder in der Pharmaindustrie.