Intermediate Validation Training (VAL02)
This one day course is designed for people who have experience in validation in GMP-regulated environments, for example;
- Quality Control, Analysts
- Operations or Manufacturing personnel
- IT professionals
- Engineers and Maintenance staff
- Validation engineers, specialists
“Commissioning, Qualification and Verification...we leave it to industry to debate these proposals; it is important we achieve a consistent understanding and application of these terms...” ISPE Pharmaceutical Engineering Magazine, July 2008
Learning Objectives and Course Description
Upon completion of this validation course participants should be able to write specification and protocols using corporate templates and will have a good understanding of;
- The Validation ‘V’ model and its application
- Validation and the regulators (TGA’s) expectations / requirements
- How to effectively participate in and add value to Validation projects and write protocols
- how to develop a meaningful URS document to enhance knowledge of key project requirements from a User's perspective
- appreciate Risk Based Validation and the value in reducing validation costs
- importance of Validation Master Plans and their key regulatory requirements
- know what IQ, OQ and PQ actually mean and participate in these key processes
- defining the interactions between Commissioning, Good Testing Practice and Qualification
- leveraging suppliers and their existing systems to minimise duplication and non value added documentation
- develop periodic reviews and Re-Validation documents
- develop ‘SMART’ acceptance criteria that ensure Validation success
- Identification of critical control points (CCP)
- Validation Summary Reports
- be able to write protocols and perform validation testing
During this one day validation course participants will have the good knowledge and appreciation of validation and be able to transform validation into a value adding activity.
Benefits include
Trainees will:
- Learn from instructors who are actively involved in validation across the life sciences industries
- Understand how to adopt sensible and international validation practices
- Receive a complete training kit, trainer’s notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
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