Process Validation for Medical Device (Face-to-Face)
Meet FDA requirements and learn the principles and application of successful process validation. Whether you’re new to process validation, or seeking to refine your process, this practical course allows you to develop a program focused on achieving both compliance and business success.
Medical device manufacturers need to perform process validation(s). The reasons are two-old: satisfy FDA requirements, and ensure business success. Attend and learn the principles and application of successful process validation. Whether you are new to process validation or want to refine and improve your existing program-you will benefit from this informative, practical seminar. You will learn how the current FDA regulations, interpretations and guidelines affect you and how to develop a validation program consistent with compliance and business success.
ASQ also offers this training course in an instructor-led virtual classroom setting, and on-site training is available for groups of five or more, offering convenience, cost-savings and even course customization when you bring our premier instructors to your organization.
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Course Data
- CEU Hours: 0.7
- Length: 7 Hours
- ASQ RU: 0.7
- Provider: ASQ
Learning Objectives:
- Familiarize with the latest FDA guidelines and interpretations of product/process validation.
- Recognize how Validation Master Plans help the planning process.
- Differentiate between qualification, verification and validation.
- Identify if (and when) validations are required.
- Determine what activities must be completed prior to conducting a validation (confirming) event.
- Learn how to conduct and document a validation event.
- Understand what to do when things go wrong (What if's!).
- Use peer feedback to learn about your own planned or completed validation programs including specific issues and questions.
Prerequisites:
NoneWho Should Attend:
Quality managers, quality engineers and quality technicians involved in the development and manufacturing of medical devices. Professionals directly involved in meeting the FDA’s quality system requirements such as those in regulatory affairs, quality assurance, process development or manufacturing.
- If you need to cancel, we will refund your paid registration fee as noted below.
- Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
- Requests received within 5 business days of the course starting incur a $150 processing fee.
- After the course starts, there are no refunds or transfers.
- Registrants who fail to attend without advance notice are liable for the entire course fee.
- If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
- You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
Enrollment Details
An instructor-led traditional classroom experience. Classroom-based instruction involves the highest level of instructor/student interaction. We offer classroom style training in two formats. See public and on-site.
| No Offerings Scheduled | English | List: $965 Member: $875 |
Corporate Training
Custom training options for your organization
Need cost-effective learning with customized delivery? ASQ can train your employees on your schedule.
5 Key Benefits of Training with ASQ:
- Single-Point Provider: Manage your teams live sessions and e-learning via a dedicated ASQ account manager for continuous guidance and support throughout your learning program.
- Reliability: ASQ's expert instructors and world-renowned quality content is at your service to upskill teams anywhere they are.
- Cost efficiency: Choose from virtual, face-to-face, and e-learning to optimize your ROI and minimize disruptions of your operations.
- Immediate results: Employees complete courses ready to apply what they have learned.
- Convenience: Get the training you need anytime, anywhere, from any device. Become an ASQ Organizational Member for even more benefits!