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The

 

INSIGHT ARCHIVE 1998-2000

        Insight Volume 11: 2008 Year Issues

• 2008 - Chapter and Verse on SOP's - November 2008

        Insight Volume 10: 2007 Year Issues

• 2007 - MDI Visits Nicaragua – June 17 – 21
• 2007 – New FDA oversight to take place – Democrats Rule – Now What?

Insight Volume 9: 2006 Year Issues

• Boston Scientific Corporation – Market Savvy but Compliance Deficient!

Insight Volume 8: 2005 Year Issues

• Will compliance to ISO-13485 assure you that you will also meet the Canadian Standards? Don’t bet on it!
• Plan B – Victim to a Politicized FDA - We Hope Not!
• FDA Inspection of Clinical Trial Sites
• 'Combination Products' - Part Two
• 'Combination Products' - Part One
• The 510(k) - an asset that can be sold and transferred
• FDA Affidavits -  YOU NEVER SIGN !!!
• The FDA - A Tale of Two Inspections

Insight Volume 7: 2004 Year Issues

• Are you as bad as the FDA483 appears to say you are?
• How the FDA is Causing Monopolies

Insight Volume 6: 2003 Year Issues

• The FDA Can Not Be Your Consultant!
• Finding the Right Consultant for dealing with an FDA Injunction
• What is the difference between ISO 9000:1994 and ISO 9000:2000?
• Maybe you should be careful about what you wish for?

Insight Volume 5: 2002 Year Issues

• The FDA can be Petitioned and...  You do have a say in the REGULATIONS that affect you.
• The turtle that wins the race…. Or, The slow moving FDA gets the final say
  CAPA: Corrective Action - Preventive Action…  aren’t they really the same
• The Olympus Recall: A lesson to be learned
• ISO9001:2000 Quality Management Systems
• Complying with the IVD Directive
• Warning Letters Review
• Closing Gaps in Our Post-market Safety Net for Medical Devices
• Risk Management: Hazard Analysis and FMEA

Insight Volume 4:  2001 Year Issues

• Design Requirements and Design Specifications
• Outsourcing - China
• What the FDA wants to Know about your Recalled Product.
• Know your Preamble? Or, better yet, KNOW YOUR PREAMBLE!! 
• Problems Encountered with Equipment Validation Software - Part 2
• Problems Encountered with Process Validations - Part 1
• FDA's Civil Money Penalty Policy - The Guidance on Reduction of Civil Money Penalties for Small Entities
• The new FDA Compliance Program for the Inspection of Medical Device Manufacturers and what it means to you
• The New Year - Keeping “arrogance” at BAY
   

Insight Archives  1998-2000

• The 1998 - 2000 newsletters

e-mail INSIGHT 

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