Excellent change forms are not enough to keep medical device manufacturers out of trouble with the FDA. That’s because inspectors are looking at more than whether your forms pass muster. They’re also trained to scrutinize how well your change control procedures support those forms — and how well you follow those procedures.

So, how do you justify and document changes? Are the right people with the right qualifications using the right validation requirements to review those changes?  And are you doing enough with training to communicate both requirements and changes?

Get the right answers — before change control issues sabotage your next inspection.

New FDAnews Management Report!
Building the Perfect Change Control Form for Medical Device Manufacturers

Drawing guidance from both the FDA and industry, this new report arms medical device manufacturers with proven tips for building change control forms that can sail through inspections. Plus, you’ll profit from practical advice on how best to use those forms and how to back them with change control procedures strong enough to satisfy the toughest inspectors from the FDA and international organizations.

Here’s how to prove you’ve used validated processes to monitor changes

Step-by-step, this report helps you master the many aspects of change control and the many regulations that must be factored into emergency decision-making and routine company procedures. From building that “perfect” change control form, to getting every member of the team – manufacturer, contractor, tester — on board and in compliance, you’ll dramatically reduce your chance of getting hit with a change control citation.

Buy now for the know-how you need to build strong change forms and the procedures to support them, including:

• Clear explanations: Understand medical device regulatory and ISO standard requirements concerning change control, plus FDA design control requirements.
• Insider intelligence: Discover exactly what FDA inspectors are trained to look for in change control systems, requests and follow up.
• Trends: Learn the current trends in the FDA’s approach — and expectations — for change control.
• Practical advice: Recommended FDA guidance documents and resources on change control, plus best practices for change control from industry peers.
• Compliance help: What types of changes must be submitted to the FDA and how to manage and implement effective change control.
• Trouble-shooting tips: Techniques to avoid common change control problems, plus real-world ideas for working successfully with change control systems, procedures and forms.

Buy Now!
Building the Perfect Change Control Form for Medical Device Manufacturers is offered by FDAnews in print and PDF format for $397 each.

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