MMD-106 Validation Process Training for Medical Device
Overview
Course Objectives
Course Content
For Whom
Schedule and Hours
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So as to ensure a process consistently produces a result or product meeting predefined specifications associated with the manufacturers claims on safety & effectiveness of its medical device(s), process validation is conducted as a means of structured approach as well as objective evidence to meet ISO 13485, US FDA’s cGMP and corresponding regulatory requirements.
Participants will be led by an experienced process validation practitioner. Participants will be able to determine which processes require validation as well as how prepare validation master plans, protocols & reports and how to conduct deviation management.
This course provides learners with:
Understanding of Process Validation requirements
Understanding the methodology of validation processes
Understanding the reference documents
Identification of validation report.
Section 1
Process Validation, definition and current approaches
Important of Validation in Technical Documentation requirement
Understanding risk assessment as part of process validation
Section 2
Processes that required validation
Identification of International Guidance Documents
Section 3
Validation process requirements
Validation methodology: IQ/OQ/PQ
Section 4
Validation documentation and support
Other Method of Validation
Those whom contribute towards ensuring the medical device meet regulatory requirements for risk management as well as those whom conduct change management, including:
Regulatory/quality systems professionals
Manufacturing engineers
Process development engineers
Those involved in validating processes
Internal & Supply Chain Auditors
This is a 1-day programme. This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
We are HRD Corp (Human Resource Development Corporation) Registered Training Provider. All of our training modules are claimable under HRD Corp.