Validation Plans and Documentation
• Describe the purpose and scope of validation master plans, outline their typical structure and contents, and explain their importance to management.
• Contribute to the creation of project validation plans and protocols.
• Identify important validation documents, specify their interrelationships, and describe how they are created and maintained.
• Prepare and use validation schedules and resource plans, explain the basics of change control, and outline regulatory requirements for reporting and validating manufacturing changes.
What will you learn?
Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This module describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company
Course outline
Validation master plan - This session describes the purpose and scope of validation master plans. It outlines the structure and contents of a typical validation master plan.
Project validation plan - This session describes how to use risk assessment to establish the scope of a project validation plan. It distinguishes prospective validation, continuous process verification, and concurrent validation. It identifies equipment and services that typically require qualification.
Validation master plan - This session describes the purpose and scope of validation master plans. It outlines the structure and contents of a typical validation master plan.Project validation planThis session describes how to use risk assessment to establish the scope of a project validation plan. It distinguishes prospective validation, continuous process verification, and concurrent validation. It identifies equipment and services that typically require qualification.
Scheduling, resource planning and change control - This session describes the purpose and use of validation schedules and validation resource plans. It discusses revalidation requirements in change management, and outlines requirements for reporting manufacturing changes to regulators.
Who Should Attend?
Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This module describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company
Learning & Career benefits
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FAQ
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1. What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.
2. Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).
3. Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.
4. Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.
5. What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.