GAMP Part 1 – Information Security in a Global Market
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.
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.
- 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
Communities of Practice Members Who Will Benefit
- Investigational Products
- Process/Product Development
- Project Management