Overview: 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 this biotech company as a case study, the webinar charts a strategy for complying with the FDA 21 CFR part 11 regulation using SharePoint. The case study begins with an analysis of the part 11 regulation and a description of the biotech company. What IT controls would they have to implement, including policies, plans and procedures, to comply with the regulation; and what information systems would be required to support the IT controls? The webinar addresses these core activities and proceeds with a description of the qualification process of the data center. The rationale for choosing SharePoint as the compliance platform for generating and maintain electronic records and electronic signatures for FDA submissions is discussed with a brief overview of a SharePoint-based approach for:

• SOP and Training Management
• Regulatory Submissions
• Clinical Trial Management
• Product Management
• Electronic Signature System

The webinar concludes with a strategy for establishing a system validation process and with lessons learned from using SharePoint as a compliance framework for meeting FDA regulations for electronic submissions.

Why should you attend: If you are working in biotech company that will be making regulatory submissions to FDA, then what is your strategy for maintaining electronic records and signatures for FDA submissions? Your email and file share work, but is your IT department ready to comply with the FDA 21 CFR part 11 regulation for maintaining electronic records and signatures for FDA submissions? How can SharePoint be used to for generating and maintaining electronic records and electronic signatures so you can comply with FDA requirements for electronic submissions? 

The webinar will follow a case study of a biotech firm and its journey down the road to compliance with the 21 CFR part 11 regulation. This firm implemented a successful approach with SharePoint as the technology platform for generating and maintaining electronic records and electronic signatures for FDA submissions. The webinar explores a strategy for starting with a basic IT Infrastructure and establishing core IT controls, qualification of data centers, and validation of a part 11 compliant document management system with integrated electronic signatures using SharePoint as a compliance platform for meeting the FDA regulation. 

Areas Covered in the Session:

• Introduction and about the presenter
• 21 CFR part 11 considerations
• Description of the Biotech company used for the Case Study
• IT Controls
  • Policy, Plans, and Procedures
  • Systems that support PPP
• Data Center Design and Data Center Qualification
• Document Management System Selection
• Using SharePoint as a Compliance Platform
  • SOP and Training Management
  • Regulatory Submissions
  • Clinical Trial Management
  • Product Management
  • Electronic Signature System
• System Validation
  • Computer System Master Validation Plan
  • Establishing a process for system validation
• Lessons Learned

Who Will Benefit:

• CIO
• COO
• IT Director, IT Manager
• Project Managers
• Business Unit Mangers
• CFO
• QA and QC Directors/Managers
• Document Managers and Knowledge Managers

Speaker Profile:

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.

Price List:
Live : $239.00
Corporate live : $479.00
Recorded : $289.00

Contact:
James Richard
Phone: 800-447-9407
Fax: 302-288-6884
Email ID: webinars@eitaglobal.com/Support@eitaglobal.com

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