TRESCAL Group

20th September

12:00 – 14:00

Farmaforum Workshop Room 1

Digitalization, new features of the Gamp5 2nd Edition guide, and relevance of the technology provider

Speakers:

Mar Díaz, Validation Technical Manager / Validation Technical Manager

Summary:

As technology has been advancing, in the era of the fourth industrial revolution, also known as Industry 4.0, business processes have become more complex, with a greater presence of advanced digital tools that allow breaking inappropriate behaviors or uses with the focus on continuous improvement of our processes, eliminating human errors, reducing costs and delays, and ensuring regulatory compliance of processes, systems and therefore products. Increasing technological complexity presents new opportunities and challenges for the industry, and therefore the regulatory framework for information systems and data integrity is evolving to create better guidance and direction for the industry.

The objective of this course is to provide an overview of the new challenges of digital transformation and give practical advice on your approach to success by reviewing key regulatory aspects (e.g. Gamp 5 2nd Edition, new EU GMP Annex 11 concept paper, GAMP RDI and IT Infrastructure Guidelines, FDA CSA approach).