09/11/2018 8:30 am - 5:00 pm
Validation Fundamentals: Equipment & system qualification
1. Goal of the training
This course is designed to explain why regulatory agencies require Validation, as well as the consequences of failing to validate processes & systems. Attendees will gain a broad general background in validation and in addition also the practical application of equipment and system qualification. The course will provide a walk through the different general steps in validation, the concrete steps for qualifying equipment/ systems, the qualification methods and the “key deliverables”. After the training the trainees can apply a basic structure for the necessary qualification documents (protocols/report) and document in a correct way.
2. Regulations considered
FDA 21 CRF, FDA guidance on process validation, EU V4 Annex15, EU V4 Chapter 4: Documentation
3. Added value
Practical training given by experts with experience in various domains. The participants will gain sufficient background and tools to work with. A come back session is planned to discuss the trainee experiences in the field.
Learning Objectives
At the end of the course participants will be able to
- Understand the concepts of Validation
- Understand why validation is important to the product quality & regulations
- Understand the whole validation approach from VMP to different types of validation
- Apply the different steps in V-cycle for equipment/system qualification
- Understand the main roles in a validation project
- Understand hot topics like QRM, ASTM & QBD
- Practice basic change analyses & write rationales
- Practise basic user requirements analyses
- Practise good documentation in validation
- Practise basic validation tasks
- Know what is expected from them on a first junior validation mission
Scope
Basic validation course containing general concepts + specifics on equipment/system qualification Pharma & life science
Not in scope but foreseen in other modules:
- Technical writing skills
- Advanced QRM
- Advanced ASTM
- Process validation, QDB and In process controls
- QC method / equipment
Methodology
- Theoretical knowledge
- Exercise through workshops
- InterVision day to practice work-related examples
Program
- What and why validation
- Types of validation
- Short Introduction to process validation
- Quality by Design
- Extended introduction in qualifying for equipment/systems:
• Steps in the Validation Life Cycle: V-Model/ASTM
• Validation plan and URS
• Quality Risk Management
• Project management for qualification:
-Approach
-Several steps and high level timelines/milestones
-Stakeholder management
-Roles and responsibilities (RACI)
-Work with suppliers
• Protocols/reports/procedures
-Templates & structure in the different documents
-Good Documentation Practices
• Change Control, Quality review and VMP (validation master plan)
• Roles and responsibilities
Bookings are closed for this event.
Practical information
Trainer: Niek De Schouwer
When: 09/11/2018: 8.30h – 17.00h
Where: Antwerp, Blue Point, Filip Williotstraat 9
This course will be provided in ENGLISH
Price per day: 750 €/excl. VAT
Discount possible:
- 30 % discount for early birds (subscription before 30th of March 2018))
- Until 50% discount through KMO portfolio or training vouchers (DV.O218731)
- Full reimbursement through Co-valent : https://www.co-valent.be/
- 50% discount for students and PHD’s
Parking spots can be found: https://www.mechelen.be
Audience
Pharma professionals who need a background in validation fundamentals or starting in validation projects.