Excel Spreadsheets: Applying 21 CFR Part 11 Compliance

Richard Chamberlain

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This webinar will discuss developing procedures for validating applications that use Excel; produce procedures for development and maintenance of the Excel applications; Standard Operating Procedures for step-by-step activities; measure quality and demonstrate compliance to regulatory and other business requirements; and produce necessary validation records.

There are many features of Excel that impact the amount and type of documentation that is needed to validate applications that are implemented using Excel. Some simple applications require less design documentation but more complex applications might require more.

Course Objective

  • How to organize the Excel processes and procedures.
  • How to Develop SOPs for Excel Validation that can be managed.
  • The Development of Training Modules to support the SOPs.
  • The production of “Products” that provide Quality Records and Demonstrate Compliance
  • How to Apply Change Control to Excel SOPs.
  • Who are and what are the roles of the various Stakeholders?

Course Outline

  • The Validation of Excel Applications
  • The Role of SOPs in Systems Development Lifecycle (SDLC).
  • The organization and content of required SOPs
  • How to prepare necessary SOPs.
  • The Content and Format of Required Validation Documentation.
  • The responsibilities of the various Stakeholders

Target Audience

  • Quality Assurance Staff
  • Auditors
  • Subject Managers
  • IT Staff
  • Regulatory Affairs
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Richard Chamberlain,

Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation, Managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs. Taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems. Assisted in the development and validation of numerous computerized systems in all GxP environments. Assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and compliance to regulations. Familiar with the various aspects of Computerized Systems and CFR 21, Part 11,FDA Guidelines for Computers, ICH-GCP, and GxPs.

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