A detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. Information to include in the protocols and reports, Statistical Process Control, Design of Experiments, usage of attribute sampling plans, discussion on GHTF document on process validation.
Learning Objectives:
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.
How It Works:
The webinar has a series of modules, each about 45 minutes long. Our speaker, Mr. O Leary, will deliver the modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants can ask questions and clarify information. The modules also include multiple-choice questions to help participants assure they understand the material. Some of the modules contain exercises for participants that help illustrate the points covered and further increase learning. The interactive portion includes a discussion of the questions and exercises.
Participants will download the material in advance so they have an opportunity to review it. This includes guidance documents and sample protocols and reports.
Convenience for Attendees:
This training is convenient to attend; you just need an internet connection. You don t have to travel from your office. This means you can afford to have your whole team attend. All the stakeholders can learn the material together; everybody will get the same information. Who should attend? The Who Will Benefit will help you select the right people in your organization.
Validated process can help you in more than one way. By understanding the process, you can improve it, with all of the potential cost savings. In addition, you can prevent action by the FDA during your next inspection.
Agenda:- 10:00 am 10:15 am - Introduction
- 10:15 am 11:00 am - Process Validation Concepts & Requirements Framework
- 11:00 am 11:15 am - Morning Break
- 11:15 am 12:00 Noon - Process Validation Approaches
- 12:00 Noon 12:45 pm - Installation Qualification
- 12:45 pm 1:45 pm - Lunch Break
- 1:45 pm 2:30 pm - Statistical Methods (Part 1)
- 2:30 pm 3:15 pm - Statistical Methods (Part 2)
- 3:15 pm 3:30 pm - Afternoon Break
- 3:30 pm 4:15 pm - Operational Qualification
- 4:15 pm 5:00 pm - Performance Qualification
Who Will Benefit:
- Process validation starts with design controls and moves to manufacturing through design transfer
- Design Engineers
- Design Technicians
- Production sets and monitors the process parameters to make the product
- Quality Engineers
- Production Engineers
- Production Managers and Supervisors
- Production Operators
- The production equipment must be installed, maintained, and calibrated
- Plant Engineering
- Maintenance Managers and Supervisors
- Validated process contribute to Risk Management
- Compliance Officers
- Risk Managers
- Regulatory affairs professionals
