Your inbox and the media are both full of offerings and commentary on cloud computing. What exactly is it? Why are IT and finance people so bullish on it? Are there regulatory implications to embracing this strategy?

This presentation looks at the technical aspects of the 'cloud' paradigm in terms appropriate for the non-IT professional. The speaker uses this information, along with current examples from industry, to explain the fiscal and technical advantages that are driving many companies to explore and/or adopt this approach. The presentation also reviews and analyzes some basic issues an FDA-regulated company must understand and take into account before jumping on the cloud computing bandwagon.

This audio conference covers:

• Defining the cloud, SaaS, virtualization and other key terms
• Understanding the business value of the cloud
• Understanding the regulatory issues of the cloud
• The multiple security issues in the cloud
• Typology of cloud computing – where is your data really located?

About the speaker:

John T. English helps clients develop and execute projects within FDA-regulated industries. With over 25 years of experience, his background includes system validation and audits for pharmaceutical and biological production, QA/QC LIMS, CIM, adverse event systems, data archiving, blood processing, medical devices and regulated software. Recently, he was retained for a two-year period to provide subject-matter expert, audit and remediation services for regulated software, as part of a major consent decree effort. He has provided validation consulting and remediation services to global, mid-size and entrepreneurial companies in the pharmaceutical, biologic and medical device industries in the United States, Europe, Israel, India and Japan.

While an active validation practitioner, John also lectures regularly in the US and Europe on Part 11, computer validation and regulatory compliance. He is a member of the FDA-PDA Joint Task Force on Electronic Information and Dynamic Validation. In addition, he was a selected presenter at the both FDA Public Conferences on 21 CFR Part 11 (Washington, DC in 2004 and Philadelphia, PA in 2000). John presented a workshop on Part 11 - Part 2 - at Interphex 2007 (New York City). He has also addressed US-FDA inspection personnel on validation issues, as well as having been the invited guest of the Spanish Association of Industrial Pharmacists (Madrid) and the Czech Pharmaceutical Association (Prague).

Who should attend?

• Regulatory Affairs
• Quality Control/Quality Assurance
• Compliance
• Documentation
• Validation
• Project Managers