|
|
 |
|
Viewing report
|
|
|
|
E-Learning Module: Fundamentals Of Process Validation
CompuPharma Ltd
This CompuPharma Validation Module is ideal for people who are new or existing employees of the Pharmaceutical industry, who require an understanding of Validation. The Module is an introduction to validation in regulated industries using case study of tablet manufacturing process. Includes validation masterplan, validation life cycle, specification, qualification and revalidation.
Objectives:
- Describe each of the four qualification stages DQ, IQ, OQ and PQ
- Describe the different stages of the Validation Life Cycle
- Explain how the qualification stages relate to the equipment specifications
- Explain the concept of the Validation Life Cycle
- Explain the concepts of change control, revalidation and decommissioning
- Explain the purpose of a Validation Master Plan and describe its contents
- Explain the purpose of process validation
- Explain the risk assessment approach to validation
- Explain the term 'validation' and why it must be performed in regulated industries
- Explain the terms DS, FS, and URS
- Explain 'traceability matrix' and describe its use in validation
- List the five established validation categories
This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.
|
|
|
|
