Aims
To provide an overview of the regulatory requirements of process validation, introduce methodologies and tools that will help identify critical process steps, and review of different approaches to process validation.
- Prospective, concurrent, retrospective validation and re-validation
- Basic statistics and how to interpret
- Describe the key requirements of Process Validation
Course Description
Companies manufacturing in the drugs, devices and biologics industry are expected to comply with all the applicable GMP requirements, including those pertaining to process validation that calls for documented evidence to provide high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics. Process validation is a key element in assuring that key quality assurance goals are met. This subject aims to introduce participants to the validation principles covered in ISO 13485, PIC/S, ICH, EU & FDA cGMPs.
The course consists of a lively mix of presentations, group exercises, and discussions. Copies of all presentation slides and handouts will be provided.
Who Should Attend
Those who are involved with process validation activities in the drugs, devices or biologics industry. Participants considering working in these industries or those wishing to enhance their professional development and advancement in management are particularly encouraged to apply.
Learning Outcomes
On successful completion of this module, the student will be able to:
- Describe the development of regulatory requirements for process validation.
- List important regulatory guidance documents.
- Understand the prerequisites of process validation
- Essential documentation for process validation
- Integration of process validation into the VMP
- Describe a risk based approach for identifying validation requirements and discuss theimplications for the product
- Discuss the requirements for routine validation and revalidation.
- Understand the linkage of Process Validation with Annual Product Review
