Course Description
A medical device production system must be efficient, effective, and compliant. This includes the right controls - documented instructions, environmental control, adequate equipment properly installed and maintained, production software, properly controlled test equipment, and validated processes. The requirements come from FDA QSR and ISO 13485:2016.
This two-day workshop covers the essentials of production and process control. Beyond the fundamental elements, the workshop provides practical methods to help create a robust system for device production - one that can withstand a rigorous FDA Inspection or MDSAP Audit. Exercises provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning Letters, the Quality System Inspection Technique (QSIT), and the Medical Device Single Audit Program (MDSAP) provide an opportunity to apply the information.
Why you should attend:
Production and process control is the essence of medical device manufacturing. It provides the framework for making devices, verifying them, validating processes, and handling problems. A device manufacturer’s production needs to satisfy the regulatory requirements to avoid MDSAP audit findings and FDA Warning Letters. By attending this workshop, you will learn the regulatory requirements and tools to help implement them.
Workshop Objectives
Understand the regulatory environment for device manufacturers including FDA QSR and ISO 13485:2016
Learn the approach regulators use to check implementation including QSIT and MDSAP
Learn the requirements for installation and maintenance of production equipment
Understand how to manage inspection, measuring, and test equipment, IM&TE
Learn the requirements for production and test software validation
Understand product verification requirements and records
Learn about sampling plans for production
Learn when to validate a process and the most common approach (IQ, OQ, and PQ)
Learn how to handle nonconforming product and keep the required records
Understand the role of quality plans, process flowcharts, and process FMEAs
Learn the concepts of production process control
Learn SPC methods for production processes
Understand the methods to calculate and use process capability
Course Audience:
Production Managers and Supervisors,Quality Managers and Supervisors,Quality Engineers,Manufacturing Engineering Managers and Supervisors,Manufacturing Engineers,Quality Management System Auditors,Risk Management Specialists,Regulatory Affairs and Compliance Staff
Agenda
Day 1 Schedule
Lecture 1: Establishing Production Controls
The development of the QMS (QSR & ISO 13485:2016)
The current versions of the QMS (US, EU, & Canada)
Design output and design transfer
Developing quality plans
Writing procedures and instructions
Monitoring and controlling process parameters
Buildings and environmental control
Personnel
Contamination control
Lecture 2: Manufacturing Equipment
Using Installation Qualification (IQ)
Equipment and OSHA standards
Developing maintenance schedules
Utilizing Total Productive Maintenance (TPM)
Measuring equipment effectiveness
Lecture 3: Production Software
Identifying software used in production
Understanding the FDA guidance document
Extent of validation (risk based approach)
Excel spreadsheets as a common example
Developing a validation protocol and report
Lecture 4: Inspection, Measuring, and Test Equipment (IM&TE)
Accuracy and precision - what they mean
Traceability to national and international standards
When there are no standards
Documenting calibration status
Adjusting calibration intervals
The external calibration lab - purchasing an outsourced process
Lecture 5: Production and Process Changes
Identifying changes
Determining responsibility for changes
Change verification
Process validation and change control
Day 2 Schedule
Lecture 1: Process Validation
Determining the need for process validation
Defining a "high degree of assurance" - process capability
The common phases of process validation (IQ, OQ, & PQ)
Monitoring, control, and documentation of process parameters
The role of qualified operators
Documenting changes and investigating deviations
Lecture 2: Acceptance Activities
Acceptance activities in the production flow
Acceptance as process control
Acceptance sampling - attributes & variables
Maintaining acceptance records
Lecture 3: Process FMECA
The role of quality plans
Developing a flowchart
Identifying failure modes for process steps
Process Improvement
Analysis - RPNs
Linking ISO 14971:2007 risk management
Lecture 4: Nonconforming Product & Corrective Action
Definitions - Correction & Corrective Action
Control and disposition of nonconforming product
Documenting nonconforming product in the Device History Record (DHR)
Corrective action as a process improvement technique
Audience
Production Managers and Supervisors,Quality Managers and Supervisors,Quality Engineers,Manufacturing Engineering Managers and Supervisors,Manufacturing Engineers,Quality Management System Auditors,Risk Management Specialists,Regulatory Affairs and Compliance Staff