| Reg
21 CFR Part 820 - Decoding Compliance
for Medical Device manufacturers
In
the 21st century, the impact of FDA inspections and fines levied for non-compliance
and high-profile product recalls are driving a powerful reaction among Medical
Device organizations. Consider this, In Fiscal 2005, the
FDA: • Conducted more than 19,000 inspections
• Issued more than 6,000 Form 483s
• Sent out 535 warning letters With
an estimated $22 million in new user fees in 2007, the FDA has planned to fund
increased reinspections and follow-up work. In this free white
paper, we’ve compiled all the information you need to improve quality, customer
satisfaction and brand reputation, reduce the costs of bringing new products to
market and eliminate numerous product stalls and recalls. So
understanding current regulations and knowing how best to adhere to them is critical.
Empowered with knowledge, business enterprises can ensure the security of both
their bottom line and their patients’ safety. This Industry
Regulation White Paper provide a concise look at those specific subparts of 21
CFR Part 820 that can be supported through cost-effective automation by:
• Meeting quality and compliance audit requirements
• Tracking personnel training and certification requirements
• Satisfying
documentation requirements
• Ensuring supplier quality requirements
• Managing SOPs, and equipment inspection and maintenance requirements
To
receive your free white paper from Pilgrim Software, simply complete the short
form below and you will be immediately directed to a page where you can download.
Note: You must provide a valid corporate email address (not web-based
mail such as Yahoo, Hotmail, or similar).
Required
Field (*)
| 
