Blogs about: Compliance
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FDA and CAPA
The FDA issued 74 good manufacturing practice (GMP)-related warning letters to device firms last year, 84 percent of which contained citations for Corrective Action Preventive Action (CAPA) system def… more »
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FDA and CAPA
abhishekkatiyar wrote 2 days ago: The FDA issued 74 good manufacturing practice (GMP)-related warning letters to device firms last yea … more »
A must training of individuals involved in carrying out research in human subjects
abhishekkatiyar wrote 2 days ago: The US government is considering setting up a register of institutional review boards (IRBs) and ask … more »
The Federal Reserve Board Approves A Final Rule Amending Reg Z For Home Mortgage Loans
Mala Mason wrote 2 days ago: July 15, 2008 By John L. Day, Jr., Esq. On Monday, July 14, 2008, the Federal Reserve Board approved … more »
Ranbaxy claims big pharma company behind falsification accusations
abhishekkatiyar wrote 2 days ago: Ranbaxy has claimed that a pharmaceutical company is making a concerted effort to depress the compan … more »
Global Audit Board Rules on Related Parties
abhishekkatiyar wrote 3 days ago: A new rule from the International Auditing and Assurance Board focuses on the risks of fraud posed b … more »
About ISO 13485
abhishekkatiyar wrote 3 days ago: ISO 13485:2003 Certification is recognized as a worldwide quality certification specific to the Medi … more »
Analyzing Risk in Medical Devices is that required
abhishekkatiyar wrote 3 days ago: Why should we perform risk analysis? 1. Risk analysis is now required by law (Revised GMP, see below … more »
Overview: FDA Regulation of Medical Devices
abhishekkatiyar wrote 4 days ago: Medical Device Definition Medical Device Recalls are either corrections or removals, depending on … more »
Ranbaxy probe includes AIDS relief meds
abhishekkatiyar wrote 4 days ago: Ranbaxy can’t be happy. The Indian company’s stock is way down for the second day in a … more »
PhRMA Code's revised guidelines take effect January 2009
abhishekkatiyar wrote 4 days ago: The Pharmaceutical Research and Manufacturers of America (PhRMA) released updates to its voluntary … more »
Asset Management with SaaS
— 1 comment
itatsmallbiz wrote 4 days ago: I previously posted on License and Patch Management which is very closely related to asset managemen … more »
FDA evolves application process
abhishekkatiyar wrote 4 days ago: The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges … more »
IFRS and When
abhishekkatiyar wrote 5 days ago: The SEC may decide soon whether and when U.S. companies will switch to international accounting stan … more »
Identification: The Breakfast of Marketing Champions
marketingspoonful wrote 5 days ago: Great things come in threes. They’re easier to remember that way. Like Tom Asacker’s … more »
Matthew Bannister: Compliance is killing creativity
Paul McNally wrote 1 week ago: The Radio Magazine: The former BBC director of radio, Matthew Bannister, has claimed the knee-jerk r … more »
Pre-Inspectional Activity for Medical Device Manufacturers
abhishekkatiyar wrote 1 week ago: Prior to the start of any medical device inspection, the factory jacket or establishment history of … more »
What is black box warning
abhishekkatiyar wrote 1 week ago: Is a type of warning that appears on the package insert for prescription drugs that may cause seriou … more »
FDA finalizing epilepsy black-box warnings
abhishekkatiyar wrote 1 week ago: Stringent epilepsy drug black-box labeling is likely to worry consumers and drug manufacturers alike … more »
Agencies Issue Statement on Basel II Advanced Approaches Qualification Process
abhishekkatiyar wrote 1 week ago: The federal banking and thrift agencies today issued an interagency statement outlining the qualific … more »
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