Brought to you by FDAnews, Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers is an in-depth management report that delivers industry-targeted guidance on change control, specifically for medical device manufacturers. Place your order now.

Get the inside scoop on medical device regulatory and ISO standard requirements for change control, including how to:

• Decipher the FDA’s new Quality System Guidance as it relates to change control
• Discover expert-recommended FDA guidance documents and resources on change control
• Put into use the ISO standard requirements concerning change control
• Avoid unpleasant surprises through current FDA change control inspection trends
• Find out what FDA inspectors are trained to look for in change control systems
• Understand what types of changes must be submitted to the FDA

Immediately deploy effective, working strategies on change control — order today, and you’ll:

• Acquire real-world, industry-wide best practices in change control from your medical device manufacturing peers
• Obtain powerful tips and techniques for dodging change control problems
• Get nuts-and-bolts advice on managing and implementing effective change control
• Have working examples of change control systems, plus procedures and forms

Don’t miss out! Successfully sidestep the delayed approvals, lost product batches and plummeting profits that can result from change control failures with this comprehensive report. Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers, click here to order.

Eight In-Depth Chapters Focus on Change Control From a
Manufacturing and Quality Assurance Perspective —
Plus Answers to Your Toughest Questions

Stay one step ahead when you know the “trouble spots” where change control problems commonly occur — and how they’ll affect you. Get the report that looks at change control from a manufacturing and quality assurance perspective, with chapters that include:

• When Change Control Fails
• Regulatory Highlights
• When do Proposed Changes Require Approval?
• What does the FDA Expect at Inspection Time?
• Common Sense Procedures
• Change Control as a Formal Process
• Reviewing Proposed Changes
• Handling Deviations, Temporary and Emergency Changes

Get specific, working strategies and recommended resources — straight from your medical device industry peers — for effective change control systems and procedures, place your order now.

Buy Now!
Don’t open the door to FDA sanctions and disastrous product delays! Order Change Control: Best Practices for FDA-Compliant Medical Device Manufacturers today, now available in print or PDF format for just $395.