Articles & Editorials from mdiConsultants, Inc.

• What is needed for FDA QSR compliance as a Specification Developer
  a warning letter was recently issued to a company (dated Sept 11, 2012) that was registered as a “specification developer”. 
   
• Foreign Companies Beware –The FDA is on the WARPATH
  FDA compliance has been much more difficult to deal with.
   
• No Silver Bullet to Complying with the US FDA GMP's 
  Article for the Chinese agency, CCUS (Certification Center International Standards)

  	CHINESE VERSION		ENGLISH VERSION
  Published in the Chinese Pharmaceutical Technology Exchange, Vol. 7 No.1 2007:  Reprinted by permission

• Japan to require ISO13485
   
• What You Need to Know About Contract Manufacturing
  An article by Alan Schwartz, appearing in the July/August 2006 issue.
   
• Outsourcing - Control is the Key to Success
  An article by Alan Schwartz and George Ye
   **This Magazine article is in Acrobat PDF format.
   
• HACCP Inspectional Approach for Medical Device Manufacturers
    "Should Industry be Accepting?"
  by Alan P. Schwartz
   
• GMP vs. ISO Considerations in Achieving ISO Certification
  By Alan P. Schwartz
   
• REVISED GMPs A call for real added value By Alan P. Schwartz
  Published in Medical Industry Executive February/March 1994