How to Develop an Effective Change Control FormPractical Advice and Tips to Keep the FDA out of Your Hair
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Drug and 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 that happen in your organization – not when help is at hand.
Here’s a quick and easy way to get in trouble with the FDA: Just mess up the change control form. As fast as you can say “Shut me down!” you could be looking at a 483 ... a warning letter ... maybe 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 drug and 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 could be so costly?
Here’s how to get advice and guidance from a top expert in the field ... plus hands-on experience creating effective and compliant change control forms to validate systems, plus understanding how to use electronic change control forms. Tune in to ...
How to Develop an Effective Change Control Form
Practical Advice and Tips to Keep the FDA Out of Your Hair
You’ll discover:
- What the change control form must accomplish ...
- Best methods for developing the form in your organization ...
- Making sure your forms address who-what-where-when-why questions ...
- The typical challenges firms face in establishing the form ...
- How to minimize possible “depth” and duration of regulatory inspections ...
- How to document changes to maintain a validated state of control ...
- Plus much more!