One of the biggest fears in regulated industries is maintaining a compliant system that is not fully controlled by your own organization. Mix in the ever-changing international pharmaceutical regulatory landscape and fold in the international laws on cloud computing and BANG…you have a big concern for your organization not moving into the Clouds!
Cloud computing is presenting itself as the cheaper, more efficient way of computing and competing in today's Life Science and Healthcare Industry, but it doesn't have to add additional risks to your organization, if you take the steps necessary to thoroughly analyze this changed technology platform; Cloud computing can offer the controls necessary for regulatory compliance. This presentation will highlight the concerns of industry and give you the confidence you need to maintain a cloud based system in a regulated environment.
Areas Covered in the Session
In this presentation, we will discuss the different compliance risks of cloud computing and how organizations can make sure they are meeting the regulatory expectations and mitigating the risks as they move into the cloud computing environment.
Mr Joseph Franchetti,
Regulatory Compliance Specialist ,
As JAF Consulting, Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation in regulated environments. For over 20 years, joe has been involved with the development, purchase, installation, operation and maintenance of computerized systems used in all phases of drug development. In addition, Mr. Franchetti has over twenty four years of progressive experience in information technology and data management in the pharmaceutical and lie science industry.
He has extensive experience with all aspects of computer systems validation and compliance and is involved with the ACDM Clinical Research-CSV Working Party working on a chapter on GAP analysis, and has recently been involved with a chapter on Risk Assessment for the recently released DIA PEACH publication on Computerized Systems used in Clinical Trials and has also been involved with the GAMP Special interest Group on Laboratory Systems publication. Joe is currently the Training Chairperson for the Society of Quality Assurance’s Computer Validation Initiative Committee.
This webinar is ideal for personnel who are new to cloud computing and would like to get a rounded view on the expectations of industry for the compliant use of cloud based application in regulated industry.
The webinar is especially useful for Computer Systems Business Process Owners, Project Managers, Quality Assurance, Internal Audit Groups, Supplier Management, Senior Management, and staff from Information Technology and Security. Vendors of Cloud based applications staff would also benefit greatly.