Course Description:
Is your production system capable of efficient, effective, and compliant device manufacturing?
It does if you have the right controls in place - including documented instructions, environmental control, adequate equipment properly installed and maintained, production software that you trust, properly controlled test equipment, and validated processes - and your system implements both FDA QSR and ISO 13485:2003.
In this two-day workshop, you will learn the essentials of production and process control. Beyond the essentials, the workshop provides practical methods to help you create a robust system that produces your devices and can withstand a rigorous FDA Inspection. Breakout sessions 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. Discussions among participants will exchange ideas and help you uncover potential solutions.
Learning Objectives:
Establishing Production Controls
Production controls start with design output and become device production specifications through the design transfer process. While the design stage ends, production controls continue for the life of the product. You will learn how to define and establish the controls needed for production including design transfer, quality plans, documented procedures, and instructions. You'll also learn techniques to identify, monitor, and control process parameters during production.
Production and Process Changes
FDA Investigators, using the Quality System Inspection Technique (QSIT), consider production and process changes as design changes and, as a result, expect appropriate documentation. You will learn how to create procedures to manage production and process changes, verify them, and determine when to apply process validation. You will also learn the aspects of document and record control that apply to changes.
Manufacturing Equipment
Properly installed and maintained production equipment is essential for a robust manufacturing process. You will learn how to perform installation qualification (IQ) to ensure you meet the requirements, including often overlooked OSHA standards. You will also learn how to create maintenance schedules, document maintenance actions, and adjust the schedules based on experience. In addition, you will explore concepts of Total Productive Maintenance (TPM) including equipment effectiveness measurements.
Production Software
When computers are part of production, the computer software requires validation before use and before any changes. You will learn how to define the software's intended use, write validation protocols, and document the results. The workshop focuses on Excel applications to illustrate the concepts.
Controlling Inspection, Measuring, and Test Equipment (IM&TE)
All IM&TE must be suitable for its intended use and capable of producing valid results. In addition, the equipment's calibration must be documented, traceable to national or international standards, and meet requirements for accuracy and precision. You will learn what accuracy and precision mean, how they relate to traceability, and what to do when the equipment doesn't meet its accuracy and precision limits. You will also learn how to document calibration activities and adjust calibration intervals based on experience. The workshop also discusses evaluation, selection, and control of external calibration laboratories through purchasing controls.
Process Validation
Production processes require validation when the manufacturer cannot fully verify the process output. You will learn how to identify these processes and validate them using Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). You will also learn about monitoring and control of process parameters to ensure the process meets its requirements. The workshop explores both the regulatory requirements and the statistical issues in process validation to provide comprehensive understanding.
Important Linkages
Because production processes are at the center of manufacturing, they link to other significant processes such as acceptance activities, nonconforming material, corrective action, and risk management. You will learn about these linkages and their affect on production process improvement.
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
Seminar Fee Includes:
Course Outline:
| Day One (8:30 AM - 4:30 PM) | Day Two (8:30 AM - 4:30 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
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Dan O'Leary President at Ombu Enterprises, LLC Daniel O'Leary 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 Master’s Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management. Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary 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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Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
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