Development of Safe Manufacturing Processes for Medical Devices
Process validation is used to demonstrate that manufacturing processes have been developed safely and will function reliably throughout the entire product lifecycle.
In this interactive seminar, you will expand your expertise and learn how to successfully conduct and design a process validation. You will learn the requirements of ISO 13485, 21 CFR 820 (FDA) and the Medical Device Single Audit Program (MDSAP) and gain access to proven methods and techniques for successfully validating processes in a way that stands up to audits.
Numerous illustrative examples and practical tips will help you apply these requirements to your company and specific products.
- Content
- Fundamentals of Process Validation
- Regulatory Framework: 21 CFR 820 and ISO 13485:2016
- Verification, Validation, Design, and Process
- Installation, Functional, and Performance Qualification
- Elements of Process Validation
- Installation Qualification (IQ) and Computer Systems
- Typical Contents of Installation Qualification
- Embedded Controls and Computer Systems
- Intended Use of Software
- Operational Qualification (OQ)
- Basics of Operational Qualification (OQ)
- Validation of a Test Method
- Performance Qualification (PQ)
- Validation Planning
- Basics of the Validation Master Plan (VMP)
- Contents of Validation Planning
- Validation Report and Documentation
- Risk-Based Sampling
- Practical Significance and Statistical Significance
- Prerequisites and Considerations
- Attributive and Variable Data
- Risk-Oriented Strategies for Sampling Plans
- Your Benefits
- You will learn about the various requirements for process validation.
- You will be able to perform validations for the manufacturing process in accordance with standards.
- You will be able to design an efficient validation process.
- You will receive practical solutions for your company
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Quality management professionals
- Medical device developers and manufacturers
- Project managers
- Process validation managers
- Software developers and IT managers
- Auditors
- Service providers
