Full Day Virtual Seminar: Medical Device Process Validation - FDA Inspectors are Checking - Are You Prepared?

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.

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:

This virtual training has a series of modules, each about 45 minutes long. Our speaker, Dan 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, sample protocols, and sample 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. Your team members 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:(EST)

• 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

Instructor Profile:

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 Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, reliability, and operations management. Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence. Ombu helps companies achieve efficient and effective processes and regulatory compliance.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001 & ISO 14001), and project management. Dan is a member of the American Mathematical Society, American Statistical Association, Society of Industrial and Applied Mathematicians, Institute for Supply Management, Project Management Institute, APICS, and is a Senior Member of the American Society for Quality and has held leadership positions in ASQ sections. He 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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