FDA 21 CFR Part 11 - IT's Role in Part 11 Compliance
This webinar discusses the 21 CFR part 11 guidelines and addresses
View DetailsSpeaker Profile
Richard Machanoff
Sr. IT Consultant, Machanoff CIO Services
Sr. IT Consultant, Machanoff CIO Services
Richard Machanoff is an Information technology leader with diverse, executive-level experience and a talent for identifying business requirements and delivering innovative cost effective IT solutions. As technology strategist, he works with top leadership to expand company capabilities and continuously improve efficiency. He has a track record of developing and implementing technology strategies that support organizational goals and streamline operations.
Mr. Machanoff holds a B.S. in microbiology, biochemistry, and chemistry from the University of Tennessee, Knoxville and an M.S. in molecular genetics from the University of Tennessee Oak Ridge Graduate School of Biomedical Sciences, Oak Ridge. He is ITIL Foundations certified and currently holds an active US DOE Q clearance.
Mr. Machanoff holds a B.S. in microbiology, biochemistry, and chemistry from the University of Tennessee, Knoxville and an M.S. in molecular genetics from the University of Tennessee Oak Ridge Graduate School of Biomedical Sciences, Oak Ridge. He is ITIL Foundations certified and currently holds an active US DOE Q clearance.
After a brief introduction to the multi-functional web technology base of SharePoint, the seminar will delve into major reasons why SharePoint implementations fail including technology issues, politics, and not having a clear picture of what SharePoint is to look like for your company, to name a few.
How to Create a Roadmap to SharePoint Success
Policies, Plans and Procedures are at the core of a well-run IT department. They define how the IT department functions and what systems support those functions. These Policies, Plans, and Procedures describe what is to be done, who is responsible for making it happen and how the actions are executed and recorded. Generally Policies, Plans, and Procedures follow a hierarchical scheme with Policies at the top level which describe Plans. Plans describe what procedures are used to implement the Plan. Procedures detail the actions to be completed. Procedures may also require guides and work instructions to provide additional detail for procedure implementation.
IT Governance - What Policies, Plans and Procedures Should be Implemented for a Well-Managed IT Department
This webinar discusses the 21 CFR part 11 guidelines and addresses
FDA 21 CFR Part 11 - IT's Role in Part 11 Compliance
A startup biotech company, with plans to eventually conduct Phase III clinical trials, realized that an attempt to maintain paper records for a phase III trial would be overwhelming. Just keeping up with the paper records for their first Phase I and Phase II trials was daunting. The company’s executives estimated that it would take 5 years to mature the corporate quality program, IT infrastructure and Information Systems to reach the goal of using electronic records and electronic signatures that complied with the 21 CFR part 11 regulation for FDA submissions. With phase III trials planned within 3 years, they needed a strategy to comply with part 11 guidelines in a much shorter timeframe. Employing SharePoint as a compliance framework, they were able to meet their schedule.
Using SharePoint as a Technology Platform for 21 CFR part 11 - A Case Study
After a brief introduction to the multi-functional web technology base of SharePoint, the seminar will delve into major reasons why SharePoint implementations fail including technology issues, politics, and not having a clear picture of what SharePoint is to look like for your company, to name a few.
How to Create a Roadmap to SharePoint Success