This course is an introduction to validation as it applies to the pharmaceutical industry. It covers the basic concepts of validation and the regulations that define scope and practices. In addition, it provides an overview for the general approach companies will take when validating equipment/systems including all qualification steps and documentation.
- Biomanufacturing faculty teaching for the community college system
- Employees working for a pharmaceutical company.
- Biotechnology curriculum students
- Basic concepts of validation
- Regulatory Compliance
- Part 1: 2011 Process Validation Guidance Document
- Process Analytical Technologies (PAT)
- Equipment and Systems Qualification
- Structure of a Validation Program
Students who have completed this course should be able to:
- Define Validation as applicable to the manufacturing process of pharmaceuticals.
- Present factors that led to FDA’s validation concept.
- Discuss the regulatory basis for the drug validation requirements.
- Review other regulatory/industry initiatives (EudraLex, ICH)
- Explain why, what, when and how validations are performed.
- Review the following document: FDA Guidance for Industry, January 2011, Process Validation: General Principles and Practices.
- Explain the structure of a validation program (documents, risk-based approach).
Delivered in-person in a classroom or lab setting.
Delivered online with a live instructor at a scheduled date and time.
This course is an introduction to validation as it applies to the pharmaceutical industry. It covers the basic concepts of validation and the regulations that define scope and practices. In addition, it provides an overview for the general approach companies will take when validating equipment/systems including all qualification steps and documentation.
- Biomanufacturing faculty teaching for the community college system
- Employees working for a pharmaceutical company.
- Biotechnology curriculum students
- Basic concepts of validation
- Regulatory Compliance
- Part 1: 2011 Process Validation Guidance Document
- Process Analytical Technologies (PAT)
- Equipment and Systems Qualification
- Structure of a Validation Program
Students who have completed this course should be able to:
- Define Validation as applicable to the manufacturing process of pharmaceuticals.
- Present factors that led to FDA’s validation concept.
- Discuss the regulatory basis for the drug validation requirements.
- Review other regulatory/industry initiatives (EudraLex, ICH)
- Explain why, what, when and how validations are performed.
- Review the following document: FDA Guidance for Industry, January 2011, Process Validation: General Principles and Practices.
- Explain the structure of a validation program (documents, risk-based approach).
Delivered in-person in a classroom or lab setting.
Delivered online with a live instructor at a scheduled date and time.