Introduction to Validation
Training
In Reading
Description
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Type
Training
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Level
Beginner
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Location
Reading
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Duration
1 Day
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Start date
Different dates available
The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies. The need for effective change management and life-cycle management will be discussed.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Validation
- Qualification
- Verification
- Pharmaceutical manufacturing
- Equipment qualification
- Cleaning validation
- Analytical method validation
- Documentation
- Regulatory Compliance
- Good Manufacturing Practice (GMP)
Teachers and trainers (1)
Steve Porter
None
Course programme
Course Overview
The course provides an overview of the concept of validation as described in Annex 15 to Eudralex Volume 4. It covers responsibilities and terminology (validation, verification, qualification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The course also examines the documentation and project management aspects of validation studies. The need for effective change management and life-cycle management will be discussed.
Suitability
The course will be of value to all pharmaceutical professionals, including management, laboratory and manufacturing staff, and engineering personnel, who need to understand the current GMP expectations of validation in today’s regulatory environment.
Learning Outcomes
At the end of the course you will:
- Understand the regulatory expectations
- Know how to evaluate validation and qualification requirements
- Be able to plan and document validation studies
- Understand the link to change management and ongoing lifecycle management
Additional information
Introduction to Validation