Elaine Duncan’s presentation to the LifeScience Alley REGULATORY 101 course was a hit with the attendees.  It didn’t hurt that each attendee received a free mini-regulatory booklet which contains the regulations for PART 11, GLP regulations, IDE regulations and QSRs all in one collection.  The talk demonstrated how the Quality System Regulations are a SYSTEM, interlocking the parts to provide a network of documentation of the quality efforts.  Comparisons between ISO 13485:2003 and Part 820 were intended to help the audience understand where key differences could lead to difficulties with FDA inspection if they are not addressed.  The presentation is available for download in this attachment.  If you would like a free regulatory booklet, please go to the Contact Us page and request the booklet.  LifeScience Alley Reg 101 Quality Systems