Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included
Who Will Benefit:
This training solution will benefit professionals in the following industries:
Medical Device, Pharmaceutical, Human Tissue, Biotechnology.
In departments such as:
QA/QC/RA, Manufacturing/Operations, Research and Development, Legal
With job functions:
Department managers and supervisors, QA/QC/RA specialists and engineers, Manufacturing, Process and R&D engineers, chemists, scientists, formulators, documentation specialists, auditors, technicians.
Participants of this course will learn key concepts essential for the validation of processes used during the manufacture of medical devices and pharmaceutical, biotechnology or human tissue products. Specifically, they will understand:
- “Why” processes must be formally validated.
- “When” processes must be formally validated
- “What” process validation is and how to plan and prepare for it.
- “How” to write and execute validation protocols, document and deal with deviations, write validation reports, and maintain the “validated state”
Process Validation has come under intense scrutiny by the FDA in recent years. This course will provide a introductory guide to planning and preparing for process validation and includes a discussion of how to write validation protocols, handle deviations, report validation results and “maintain the validated state”. Further, this course provides “content understanding” so important for auditing validation activities.
- Section 1:
- Background-Regulatory Requirements
- Why do I need to validate processes?
- What is process validation?
- Does every process need to be validated?
- So when do I need to validate a process?
- Section 2:
- Validation Planning: The Validation Master Plan
- Validation Basics
- IQ, OQ, PQ: what are all these letters in the alphabet soup?
- Validation Protocol Basics and Content
- Section 3:
- Handling Deviations
- Validation Reports
- When do I need to do all this?
- How do I “maintain the validated state” and what does that mean, anyway?
Order On-Line to Own This CD Webinar: $195.00