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-fold: 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 on-site training for groups of five or more, offering convenience, cost-savings and even course customization when you bring our premier instructors to your organization.
ASQ virtual courses provide electronic access to course materials for 30 days beginning five days before the first day of your course. Extensions and/or refunds cannot be issued if course materials have been accessed. Chrome and Edge browsers are recommended – Internet Explorer is not supported.
- CEU Hours: 0.7
- Length: 7 Hours
- ASQ RU: 0.7
- Provider: ASQ
- 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.
Who 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.
- Process Validation — The FDA Quality Systems Regulation (QSR)
- The Process Validation Model
- Validation Components
- Validation Master Plans
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Validation Tools
- Sample size determination
- Performance Qualification (PQ)
- Numerous team exercises
This course is a one-day live, instructor-led, interactive virtual course.
Pdf version of slides, handouts
After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.
- Computer – PC or Macintosh
- High-speed internet connection
- Adobe Flash Player 10.3 or later
- Windows: Internet Explorer 8 or later, Google Chrome (latest version), Firefox (latest version)
- Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)
- For instructor-led virtual WebEx courses, a speakerphone or telephone headset in a designated room or space with no distractions (preferred)
NOTE: Refer to product description for any additional system requirements.
WebEx – Virtual Course: Advance Preparation and Student Information
Join a Test Session
We strongly suggest that you join a WebEx test session in advance of your scheduled virtual training, using your preferred web browser. This can help prevent problems launching content the day your training begins.
If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.
To join a test session (meeting), click here and enter your name and email address to join. If successful, you will see a screen that says "Congratulations! Your system is now set up properly ..."
Deactivate Pop-up Blockers
You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.
- 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.
A web-based, live, classroom-like instructor led experience allowing attendees to interact without traveling. Course includes online access to materials for a limited time and up to three hard copy prints. Some courses include an electronic book – see course description for details.
ON-SITE TRAINING FOR YOUR ORGANIZATION.
ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.
5 Benefits of On-Site Training
- Expertise to your location: Saves time and travel expenses
- Convenient scheduling: Train groups of five or more
- Customizable courses: Training tailored to your groups’ needs
- Immediate results: Employees complete courses ready to apply what they’ve learned
- Value-add support: Instructors available to answer questions after session