Dates: 16th – 20th February 2015
This 5 day programme is designed to provide detailed understanding of the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485. The course aims to explore in some depth validation activities, the regulatory reasons of these activities and how best to meet these requirements.
The cost of this course is €995 (10% discount for Plastic Ireland/IBEC members) including course manual, lunch and refreshments.
- Process Control – how we control processes – Line clearance, first piece, line checks and final order inspection – does this control every part we make?
- Why is validation necessary to guarantee reproducibility?
- Principles of validation.
- Drafting User Requirements Specifications (URS) and Functionality Specifications(FS).
- Review of regulatory requirements: ISO EN 13485:2012, FDA QSR’s, Guidance Documents
- The Validation Flowchart – process map
- The use of Tools for product and process validation: FMEA, DOE, etc.
- Master Validation Plan (MVP)
- Installation Qualification
- Operational Qualification, Worst Case Scenario, Operational Windows
- Equipment IQ/OQ- using URS and FS
- Performance Qualification- Design Space generation – rationale for selecting certain inputs
- Design Validation
- Clinical Testing and Validation
- Design of Experiments – how to execute one
- Process Qualification / Validation
- Grouping Rationales for Validation
- Responsibilities within the validation project team.
- Validation Documentation Stages and documents: SOP, MVP, IQ, OQ, PQ ; Protocols and Reports
- Some Compliance Issues relating to Validation
- Life Cycle approach to validation projects
- Computerized System Validation, Automation *
- Retrospective Validation
- Cleaning Validation*
- Risk Assessment & Validation
- Q & A Session
- PDCA ( Plan Do Check and Act) and Validation
- Life Cycle approach to Validation
- Preparing for regulatory compliance
* A separate course is available in Computer Software Validation. All of these topics will be expanded on and Case Studies / Examples will be included in order to best communicate the method for validation.
9.15 am to 5.00 pm