Manufacturing Process Validation for Medical Devices

Manufacturing Process Validation is a mandatory regulatory requirement for Medical Device manufacturers. The FDA–QSR the EU MDR/IVDR and ISO 13485 include explicit requirements for Process Validation. The Process Validation maps all manufacturing processes and identifies those which must be validated. For these processes Validation Protocols and Reports are prepared documenting the evidence for the capability of these processes.

During this course the topics of Process Validation will detailed including effective methods and tools.

Content:

Regulatory Requirements
Definitions
When is validation required?
Process Development and Optimization
Statistical Aspects of Process Validation
Risk Management (פFMEA)
Test Method Validation (TMV)
Process Validation Master Plan (PVMP)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Process Validation Protocols & Reports
Maintaining State of Validation and Re-Validation
Retrospective Validation
Process Validation Examples

Understanding the Regulatory Requirements
Providing an overall strategy for process development, optimization and validation
Providing methods and tools for process validation including statistical considerations
Outline an effective and streamlined validation process that complies with the regulations and standards

Medical Device Industry professionals from disciplines such as: Quality Assurance, Regulatory, Project / Product Management, Engineering, Design & Development, Operations.

Registration Form

Course title: Manufacturing Process Validation for Medical Devices

Information

Live online training via Zoom;
View presenter and interact with attendees;
Certificate will be sent after completing the course;
Before attending the course, you will be sent the meeting ID, passcode and link for the course.

Registration Fee

Early Registration: $700 (Until 28 Apr 2023)

Regular Registration: $780 (Until 20 Jun 2024)

Late Registration: $900 (Until 27 Jun 2024)

$900

Per person (Tax included)

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