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FDA 21 CFR Part 11 - IT's Role in Part 11 Compliance

Training Options

  • Tuesday, April 28, 2015 |   10:00 AM PST | 01:00 PM EST |    Duration: 90 Minutes  
  • Corporate Live 2 to 5 participants from a single location (For multiple locations contact Customer Care)
    Price: US$399.00
  • Corporate Live 6 to 10 participants from a single location (For multiple locations contact Customer Care)
    Price: US$699.00
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: US$219.00
  • Refund Policy


This webinar discusses the 21 CFR part 11 guidelines and addresses

  • Open vs. closed systems
  • Digital vs. Electronic signature
  • Core Policies, Plans and Procedures for IT Controls
  • Systems that support IT Controls
  • What is computer system validation?
  • Components of a Computer Systems Master Validation Plan
  • The importance of internal and external audits

Preparing IT resources to install, operate and maintain validated hardware and validated systems requires strong corporate governance, IT management and project management. A well-defined QA program is essential, including elements of Document Management, Records Management, and SOP management.

Once a system is validated, the operational phase of the validated system requires strong IT controls. During the validation process and throughout operation of the validated system, IT controls become essential to maintain compliance with the regulation. IT controls must be well documented with implemented procedures for:
  • Security
  • Operation
  • Change Control
  • Configuration
  • Maintenance

Examples taken from experience in successfully validating systems and electronic signatures for a biotech/pharmaceutical company will be discussed. The company had a sound IT department (email, desktops, file shares and communications worked reliably), but IT governance was immature. Lessons learned along the path to regulatory compliance will also be discussed.

Why Should you Attend:
  • Your company is regulated by FDA and a business unit manager wants to move from paper documents and files to electronic records. She also wants to use electronic signatures, what does the IT department have to do to ensure compliance with the FDA regulations for the business unit to switch?
  • Your QA manager tells you that you must be using validated systems, what does that mean?
  • How are digital and electronic signatures different?

If your IT department does not have the proper IT controls in place, you are faced with significant paperwork just so you can use electronic files and electronic signatures in a manner that meets the regulatory guidelines. 21 CFR part 11 sets the guidelines for electronic records and electronic signatures, but it does not define how those guidelines are to be implemented. There is extensive preparation required by IT and QA before you can use electronic records and electronic signatures in a manner that will meet regulatory approval and comply with the guidelines.

This webinar provides an overview of documentation requirements and systems that can be used to meet the 21 CFR part 11 regulation guidelines.

Areas Covered in the Session:
  • Introduction
  • 21 CFR part 11
    • Electronic Records and Electronic Signatures
  • Types of Systems
    • Open Systems
    • Closed Systems
  • IT Controls
    • Policies
    • Plans
    • Procedures
    • Systems that support procedures
  • System Validation
    • Computer subsystem validation
    • What systems need to be validated?
  • Computer Systems Validation Master Plan
    • Components of CSMVP
    • Validation requirements for system installation
    • Validation requirements for system operations
    • Internal and external audit
  • Lessons Learned

Who Will Benefit:
  • CIO
  • COO
  • IT Director
  • IT Manager
  • Business Unit Mangers
  • CFO
  • QA Directors/Managers
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.

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