Quality Performance Improvement
Training Synopsis
This training is designed to established procedures and work instructions for manufacturer with critical process in medical device manufacturing.
Introduction
Learning Objective
Duration
Methodology
Target Participants
Course Outline
Training Certificate
Why Us?
Introduction
Medical device manufacturer is required to determine critical process that need process validation. The manufacturer shall plan the validation, implement the plan base on established procedures and work instructions. Process Validation is one of the critical process in medical device manufacturing. It is fundamentally an applied statistics.
Learning Objective
By the end of the training, participants would be able to:
- Develop basic understanding of regulatory / requirements such as FDA QSR, ISO 13485, ISO 14971 etc that is relevant to process validation
- Develop basic understanding of GHTF guidance, FDA’s QSIT
- Develop basic understanding of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) model
- Develop good understanding to relevant regulatory requirements and the statistical methods needed to perform an effective process validation for medical devices
- Develop good understanding to process validation approaches that supports relevant production and process control
Duration
2 days (9.00am to 5.00pm) or duration proposed at quotation.
Methodology
Training session includes classroom lecture, exercises, group work and discussion.
Target Participants
Top management, Managers, Executives, design engineers, production engineers, quality engineers, and production crew.
Course Outline
- Introduction
- Benefits of Process Validation
- Validation Regulatory Requirements & Guidelines
- Validation Master Plans
- Case study (Determining what needs to be included in the VMP for a specific manufacturing process)
- Validation versus Verification
- Exercise on validation versus verification
- Statistical Methods & Tools for Validation
- The application of Risk Analysis to Validation
- Equipment Qualification
- Requirements Specification
- Case Study Preparation of URS, FRS and FDS documentation
- IQ, OQ and PQ
- Case Study Preparation of Validation Protocols
- Design Qualification and requirements tracing
- Product & Process Validation
- Continued Process Verification
- Maintaining the Validated State
- Test Method Validation for physical test methods
Training Certificate
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.
Investment
Contact our Customer Care Hotline 012-713 3356 / 011-2128 4750 or email to ntsask@gmail.com / sales@peplow-warren.com for your best solution and offer.