Production and Process Control: Building a Robust System (Chicago, IL, United States - July 26-27, 2018)

  • ID: 4535574
  • Conference
  • Location: Chicago, IL, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: July 26-27, 2018
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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.

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
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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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  • Dan O'Leary Mr Dan O'Leary,
    President ,
    Ombu Enterprises, LLC

    Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

    He is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

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  • 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
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Hilton Garden Inn Chicago OHare Airport
2930 S River Rd
Des Plaines
Chicago, IL
United States


From O'Hare International Airport:
10000 W O'Hare Ave, Chicago, IL 60666.

Head southwest on I-190 W (141 ft.)

Take the exit toward Bessie Coleman Dr-
(0.4 mi.)

Use the right 2 lanes to turn right onto Bessie Coleman Dr-
(0.2 mi.)

Use the right lane to take the Interstate 190 ramp to Interstate 90/Chicago/Interstate 294-
(0.2 mi.)

Merge onto I-190 E-
(1.4 mi.)

Keep right to continue on Exit 1A, follow signs for North River Road and merge onto Des Plaines River Rd/N River Rd-
(Continue to follow N River Rd.)

Destination will be on the left-
(1.6 mi.)

Hilton Garden Inn Chicago OHare Airport-
2930 S River Rd, Des Plaines, IL 60018.

Note: Product cover images may vary from those shown