GAMP Part 1 – Information Security in a Global Market

Session 205
Manufacturing Operations Track

Ensuring information security is the number one challenge of any global company. Pharmaceutical and biotech companies have the added exposure of patient liability and safety. Moreover, Intellectual Property protection is a very real issue in the emerging markets.

Session Description

This session will discuss proven approaches and technologies which can methodically eliminate information breaches without compromising compliance or regulatory commitments and meeting the strategic imperatives of the business. The first part of this session focuses on the evolution of Brazilian regulations on CSV and the current requirements in comparison with USA and EU regulations.

The second part of this session will review and discuss methodologies and technologies for addressing security threat assessment and risk management across the global Supply Chain, including clinical trial data management, IP management and regulatory submissions. The session will discuss methodologies for analyzing and mitigating process risks as well as discuss the strengths and weaknesses of best in class technologies (e.g., RFID, bar coding, firewalls, monitoring systems) for minimizing information breaches.

At the conclusion of this session, participants will:

Understand the history and regulatory evolution on CSV in Brazil and alignment with GMP
Understand current Brazilian requirements and regulations for CSV and analyze the relationship between Brazilian regulations and the USA/EU regulations
Understand how to assess information system risks and how to approach mitigation across the global supply chain
Have been exposed to strengths and weaknesses of established Best-in-Class technologies.
Understand what is on the horizon in terms of track and trace and security technologies.
Be aware of the available methodologies and technologies for addressing security threat assessment and risk management across the Supply Chain.
Learn about mitigating process risks as well as the strengths and weaknesses of best in class technologies (e.g RFID, bar coding, firewalls, monitoring systems) for minimizing information breaches.

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom

Who Should Attend

Manufacturing / Operations
Service Providers
Suppliers
Regulators

Communities of Practice Members Who Will Benefit

Biotechnology
C&Q
GAMP
Investigational Products
PQLI
Process/Product Development
Project Management

More information on ISPE's Communities of Practice