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Process validation for medical devices
Thursday, November 15, 2012 from 7:00 AM to 1:00 PM (PST)
Palo Alto, CA
This 6-hr training provides a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. Information includes preparation of protocols and reports, application of Statistical Process Control, concepts of Design of Experiments, using attribute sampling plans, and a discussion of GHTF document on process validation.
Why Should You Attend:
In your manufacturing processes, how can you be sure the output is right if you don’t check every piece? Many manufacturers face this problem, but don’t always have a good solution. The FDA expects you to answer it using process validation. Using the Quality System Inspection Technique (QSIT) the Inspector will ask for process validation procedures and the results for your product. Product, as defined by QSR includes components, in-process devices, and finished devices.
Do you know which processes in your firm require process validation? Can you provide objective evidence that you evaluated each process and documented the decision?
With the FDA looking closely, can you show how the product requirements moved from design through Design Transfer to Production? Can you show that you validated and monitor the production processes? The lack of procedures and data can lead straight to 483s, warning letters, and even product seizures.
Attend this full-day virtual seminar with quality and compliance expert Dan O'Leary and you can learn the established methods to validate and control your processes.
Sign up your entire team and get a clear understanding of the requirements and methods for process validation, including:
- Understanding what “a high degree of assurance” means in statistical terms.
- The three step approach employing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Developing protocols and reports for IQ, OQ, and PQ.
- What information to include in the protocols and reports.
- How to use the link the IQ Protocol to OSHA requirements to enhance your total regulatory compliance.
- The basics of Statistical Process Control (SPC) to help monitor the validated process.
- The role of Design of Experiments (DOE) to help define acceptable process parameters and develop challenge points.
- Using attribute sampling plans in process verification.
- The FDA Guidance document on process validation and the current status from the CDRH view.
- The Global Harmonization Task Force (GHTF) document on process validation.
Date: November 15, 2012
Time: 07:00 AM-01:00 PM PDT
Cost: $699 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.