Course "Production and Process Control: Building a Robust System" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
- 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
Who will benefit:
- 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
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
- 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
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President, Ombu Enterprises
Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.
Location: Chicago, IL Hotel: Hilton Garden Inn O'Hare 2930 S. River Road Des Plaines, IL 60018