DHC Web session

New ISPE GAMP® Good Practice Guide:
Enabling Innovation

New ISPE GAMP® Good Practice Guide: Enabling Innovation

In the regulated environment, all computer-based systems used must be validated before their productive use and the infrastructure used must be qualified. Agile methods for implementation and the ever-increasing use of cloud solutions or the use of e.g. SaaS pose new challenges to previous approaches.

With the Critical Thinking approach, a new paradigm is entering and creates the opportunity to break down barriers in the introduction of new, innovative technologies.

We will shed light on what motivated the new Good Practice Guide, what changes are opening up in terms of effort and scope in the areas of testing and documentation, deal with the cited “critical thinking” and outline the potentials opening up in the context of digital transformation.

DATE

Friday, 11 February 2022, 10:00 – 10:45 a.m. => You missed the web session? Then request the podcast now!

Target group of the web session

This webinar is aimed at specialists and managers from the areas of quality management / quality assurance and IT in companies in the regulated environment (pharmaceuticals & medical technology).

Content of the web session

  • What does the new Good Practice Guide contain ?
  • Motivation for this new guide
  • Are there already practicable approaches for CSA (Computer Software Assurance) ?
  • Implications / challenges for the future of Computer System Validation (CSV)
  • Possible solutions / development potentials of CSV
  • Summary and answering questions

Your benefit

  • Overview of the topic and use cases by CSV experts
  • Over 25 years of industry know-how in the validation of computerised systems
  • Over 25 years of consulting know-how in risk management
  • Lessons learned from many successfully implemented validation projects in the GxP environment
  • Interactive exchange with our experienced consultant and other web session participants

TECHNICAL REQUIREMENTS

The web sessions are online seminars. To participate, all you need is a PC with an internet connection and loudspeakers. Alternatively, sound can be transmitted via telephone, while you can follow the image presentation via your browser. The web sessions are interactive, i.e. you can ask questions at any time.

PARTICIPATION AND REGISTRATION

=> You missed the web session? Then request the podcast now!

The web session was held in German. If you only speak English, please contact us via email for a personal online appointment (consulting@dhc-gmbh.com). We are looking forward to meeting you!

Our web sessions are a free service for customers and interested parties of DHC.
IT service providers and consultants are excluded from participation.

SAP and other SAP products and services mentioned as well as their respective logos are trademarks or registered trademarks of SAP SE in Germany and other countries.

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