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K-C receives FDA clearance for all ASP STERRAD system modalities

2013-09-05 07:00:00| Nonwovens Industry Breaking News

Kimguard family of sterilization wrap is the most validated sterilization wrap on the U.S. market.

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Six Ways To Optimize Your Quality Management System And Ensure FDA And ISO Compliance

2013-09-05 03:36:13| drugdiscoveryonline Downloads

How much does quality cost? Most companies would be hard-pressed to translate “quality” into dollars and cents. What they realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.

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Noncompliance To FDA Quality Standards: What's The Risk To Executives?

2013-09-05 03:28:43| drugdiscoveryonline Downloads

Your life science company--hypothetically speaking--is now a successful and growthoriented organization. Thus far, you’ve kept governmental regulations in check, quality is steadily improving, and you’ve even managed to lower the cost of production.By Michael S. Heyl

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Managing Change Control To Comply With FDA And EU Regulations

2013-09-05 03:10:50| drugdiscoveryonline Downloads

When properly implemented, change control is a potent force for improving the efficiency and effectiveness of a quality system. Many organisations find change control management to be a major problem because of the extensive documentation it generates, and the difficulty of managing the large number of interrelated elements and departments that are often involved.

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21 CFR Part 11 Industry Overview: Ready For An FDA Inspection?

2013-09-05 03:02:29| drugdiscoveryonline Downloads

The U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 in 1997 to establish criteria for the use of electronic records andelectronic signatures by organizations that comply with the federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

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