The digitalization era and data integrity. The industry view

Moderator of the Event: Anna Plesovskikh, Managing Partner, PharmaPharm

13:10-13:20. Registration of the participants
13:20-13:30. Signing Partnership agreement between PharmaPharm & GMP News
13:30-14:20. Discussion panel: «Data integrity management: key points»

Main conceptions:

Digitalization trends. Big Data. Main milestones. Time challenge
Data integrity and security in GxP: regulatory requirements assessment
Data integrity guide: competency review
Quality management & digitalization: main control points
Data integrity in pharmaceutical manufacture. The implementation results in a dynamic perspective (R-Pharm as an example)
Data integrity (based on Agilent OpenLAB CDS 2 software)
Electronical system for development of registration dossier for pharma product (as a tool of ensuring constant data)
Actual ISPE documents for ensuring data integrity. Conception and benefits of using ISPE GAMP Guide and the ISPE GAMP 5
Equipment and automatization: practical aspects of implementation and operation

Invited experts:

Yuriy Sandler, Executive Director in CIS countries, PQE
Tatyana Vyazmina, Quality Director, R-Pharm

Tatiana Lebedeva, Business Manager, Gluvex
Dmitry Polstyanov, General Manger, X-tech
Oxana Pryanichnikova, Development manager, Heuft Eurasia, representative of ISPE, Eurasia
Yuriy Belykh, product specialist, Agilent Technologies LLC, Russia
Аnna Plemyashova, Corporate strategy and development director, Beltel
Konstantin Koshechkin, Head of the informatization Department, Russian Ministry of health
Igor Falkovskyi, Head of Good Engineer Practice, SED and GP