Production and Process Control: Building a Robust System (OCP)

Production and Process Control: Building a Robust System (OCP)
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, ISO 13485:2003 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. Exercises provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning Letters and the Quality System Inspection Technique (QSIT), provide an opportunity to learn from the experience of other companies. The workshop includes the elements from the Medical Device Single Audit Program (MDSAP).

Learning Objectives
Understand the regulatory environment for device manufacturers including FDA QSR, ISO 13485:2003 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 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 FMECAs
concepts of production process control
Learn the underlying statistical concepts including statistical distributions and decision making
Understand data types (attributes and variables)
Learn the SPC methods available for the data types
Understand the methods to calculate and use process capability

Why Should you 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 audit findings and pass FDA Inspections. By attending this workshop, you will learn the regulatory requirements and tools to help implement them.

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 One (8:00 a.m. - 8:30 a.m.: Registration Process)

Part A - Establishing Production Controls
The development of the QMS (QSR, ISO 13485:2003, & 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
Part B - Manufacturing Equipment
Using Installation Qualification (IQ)
Equipment and OSHA standards
Developing maintenance schedules
Utilizing Total Productive Maintenance (TPM)
Measuring equipment effectiveness
Part C - 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
Part D - 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
Part E - Production and Process Changes
Identifying changes
QSIT and design changes
Determining responsibility for changes
Change verification
Process validation and change control

Day Two

Part F - 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
Part G - Acceptance Activities
Acceptance activities in the production flow
Acceptance as process control
Acceptance sampling - attributes & variables
Maintaining acceptance records
Part H - 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
Part I - 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

Daniel O'Leary - President, Ombu Enterprises, LLC

Dan is the 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 is certified by APICS in Resource Management.

Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

This Event Listing is Promoted by
New York Media Technologies LLC in association
with HOLKOI.

at Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, United States



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