Advanced Validation Training (VAL03)
This one day course is designed for experienced validation professionals wishing to brush up on their knowledge and gain insights into current industry best practice, for example;
- Quality Control personnel performing method validation
- Operations or Manufacturing personnel doing process validation
- 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 design and write plans, specifications and protocols using corporate templates. Key leaning objectives are;
- design and setup validation programs, policies and standard operating procedures
- use risk assessments for validation, using direct and indirect systems to reduce validation effort and reduce validation costs
- how to effectively lead and direct validation projects
- a detailed understanding of the validation ‘V’ model approach
- understand and implement Risk Based Validation methodology to reduce Validation effort, time and costs, i.e. GAMP 5 and the ‘ASTM 2500 E’ approach
- develop Validation Master Plans and their key regulatory documentary requirements
- develop IQ, OQ and PQ processes and direct these key processes
- understand Commissioning, Good Testing Practice and Qualification and how these systems interact
- leveraging suppliers and their existing systems to minimise duplication and non value added documentation
- develop ‘SMART’ acceptance criteria that ensure validation success
- debate the merits of Process Analytical Technology (PAT) and the associated mechanisms for reducing Validation efforts
- use GXP criticality assessments to drive validation workloads and priorities
- create validation deliverables lists to direct their validation tasks
- participate in developing a URS document to enhance their knowledge of key project requirements from a user’s perspective
- Identification of critical control points (CCP)
- able to manage and guide validation projects
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.
This course does not cover computer systems validation, this is covered in separate series of courses.
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.
 |
 |
|
|
 |
