What Exactly Is Required for 21 CFR Part 11 Compliance

Richard Chamberlain

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  • Developing Procedures for validating applications;
  • Produce Procedures for Development and Maintenance of Applications;
  • Standard Operating Procedures for Step-by-Step Activities;
  • Demonstrate Compliance to Regulatory and other Business Requirements;
  • Produce Necessary Validation Records;

Course Objective

  • How to organize processes and procedures.
  • How to Develop SOPs for 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.
  • Who are and what are the roles of the various Stakeholders

Course Outline

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

Target Audience

  • IT Staff
  • Quality Assurance Staff
  • Auditors
  • Subject Managers
  • 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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