DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Production and Process Control: Building a Robust System" conference to their offering.
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).
- 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
For more information about this conference visit http://www.researchandmarkets.com/research/bsxw4k/production_and