Change Control Forms for Medical Devices Current Best Practices for FDA-Compliant Systems
Devicemakers that don’t pay close attention to change control forms could be in for a nasty surprise next time the FDA investigator calls.
Don’t let it happen in your organization — help is at hand.
Here’s a quick and easy way to get in trouble with the FDA: Make a mistake on the change control form. As fast as you can say “Shut me down!” you could be looking at a 483 ... a warning letter ... or even an order to delay shipping products.
Change control forms monitor changes over time in validated processes. They ought to be simple and routine.
Why, then, do so many device manufacturers get them wrong?
Simple answer: They’re harder than they look. In fact, they’re rife with pitfalls. Do you know …
- The top five most common deficiencies on change control forms?
- What FDA investigators will be looking for ... and how that may differ from what international regulators will look for?
- Whether change control forms are effective tools for managing OOS investigations and CAPA programs?
Isn’t it time you started paying more attention to the way your organization handles change control forms? Especially when mistakes can be so costly?
Take a proactive step and tune in to Change Control Forms for Medical Devices on Thursday, Sept. 16 to get advice and guidance from Barbara Immel, a top expert in the field with hands-on experience creating effective and compliant change control forms to validate systems … plus in-depth understanding of how to use electronic change control forms.
- What the change control form must accomplish
- Best methods for developing the form in your organization
- How to ensure your forms address who-what-where-when-why questions
- How to minimize possible “depth” and duration of regulatory inspections
- The typical challenges firms face in establishing the form
- How to document changes to maintain a validated state of control
- Plus much more!
Like every FDAnews webinar, Change Control Forms for Medical Devices is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-at-home.
Of course, Ms. Immel will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in change control forms deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.