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21 CFR Parts 210-211 - Decoding Compliance
for the Biologics Industry
The
demand for healthcare products is ever increasing and this growing trend is reshaping
the Pharmaceutical and Biologics industries. With the demand for products, comes
the concern among pharma-bio manufacturers for regulatory scrutiny. Taking a proactive
approach in addressing the risk of non-compliance is leading today's drug manufacturers
to implement a vigorous, enterprise-wide compliance management solution that can
be leveraged to enhance business processes.
With millions
of dollars 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. Understanding current
regulations and knowing how best to adhere to them is critical in this changing
market. 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 Parts
210-211 that can be supported through cost-effective automation by: - Meeting
quality and compliance audit requirements
- Tracking CGMP
training and certification requirements
- Managing policies,
procedures, electronic records, complaints and other processes
- Maintaining
supplier quality and performance history
- Tracking product
discrepancies and associated investigations
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).
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