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Experts Talk: Using Pharmaceutical ALM for GAMP 5 Compliance

Webinar Date Time Duration
Wednesday 7 Jun 2017 4:00 PM (CEST)
/ 10:00 AM (EST) / 7:00 AM (PST)
~30 minutes

What you can learn:

Drawing on the experience of guest speaker Kálmán Keresztesi (Controsys Control Engineering Ltd.), the focus of this webinar is risk management and compliance in the pharma industry. Pharmaceutical companies face challenges when setting up distributed control systems or automated production systems for pharmaceutical products. In addition to pharma companies, suppliers of pharma production devices and system integrators are also facing the challenge of complying with GAMP.

GAMP 5 applies a risk-based approach to compliant GxP computerized systems that needs to be followed during the design and operation of devices used in pharmaceutical production. Intland Software is now among the first ALM vendors to provide full support for pharma companies and their manufacturing device suppliers to comply with GAMP 5 while reducing the costs of audit and process management.

Join this webinar to learn how codeBeamer ALM and Intland's Pharma GAMP Template support compliance, including:

  • the basics of the Good Automated Manufacturing Practice
  • GAMP-compliant pharmaceutical development using codeBeamer ALM
  • Intland's Pharma GAMP Template

Are you interested in the webinar, but the date & time is not suitable? Simply register to receive a link to the webinar's video recording after the event!

Speaker:

kalman-keresztesi-controsys.jpgKálmán Keresztesi has more than 20 years of experience in validated pharmaceutical automation projects delivering complete DCS and SCADA applications and providing engineering & consultancy services for key suppliers and to end users. He has worked with global companies including Richter Gedeon, Takeda, and MSD.

 

The webinar's agenda:

  1. The basics of Good Automated Manufacturing Practice (GAMP)
  2. Integrated ALM in pharma development
  3. Implementing GAMP-compliant processes in codeBeamer ALM
  4. Intland's Pharma GAMP 5 Template
  5. Live demo of codeBeamer ALM & Intland's Pharma GAMP 5 Template

Our webinar is intended for:

Business Analysts, Pharmaceutical Companies: System Integrators, Pharmaceutical Suppliers, Pharmaceutical Production System Developers, Compliance Experts, C-level IT Executives, Quality Assurance Professionals, Senior Software Staff, Project Managers, Software Engineers & Developers

Intland Webinar: Experts Talk: Using Pharmaceutical ALM for GAMP 5 Compliance