Building a high level of knowledge to maximize the efficiency of pharma manufacturing process

Plant managers will need to hone many skills that include: technology, regulatory and compliance, health economics and how to be a facilitator to technologies that allow levels of access and process customization that were previously inconceivable.

Check out the agenda

REGULATORY & DEVELOPMENT

27 Octubre - 28 Octubre

Management strategy to reduce time to market

Data Integrity a Novartis approach

27 Octubre - 27 Octubre Montjuïc, Pavelló 5, Espai Palau de Congressos de Barcelona, Sala 3

Annex 15 and new FDA/EMA validation guide

27 Octubre - 27 Octubre Montjuïc, Pavelló 5, Espai Palau de Congressos de Barcelona, Sala 3

Industry Session - EU GMP change – impact on cleaning and process validation

27 Octubre - 27 Octubre Montjuïc, Pavelló 5, Espai Palau de Congressos de Barcelona, Sala 3

The current European changes, will also explain the changes of recently effective and draft documents as the annex 15, annex 16, chapter 2, chapter 3, chapter 5 and finally the EMA guidance on setting limit. Will explain the impact of these changes on cleaning, process validation and explain the difference with the ISPE and FDA guidance. And share the common questions asked and what regulatory agency are expecting to be in place.

Medical Device Innovation

27 Octubre - 27 Octubre Montjuïc, Pavelló 5, Espai Palau de Congressos de Barcelona, Sala 3

A clinical evaluation is a required element of the conformity assessment process in the European Union for medical devices. Clinical investigation are performed to demonstrate valid clinical evidence of the safety and performance of the device, and post-market clinical follow up with medical devices add value to the product. It is essential prepare clinical evaluations correctly