11th Annual FDA and the Changing Paradigm

The 11th Annual FDA and the Changing Paradigm for Blood Regulation Meeting covered a range of topics including a workshop approach.

Blood Systems Inc. is very active and well represented at this year’s annual meeting. The Keynote Speaker was our very own Mr. J. Daniel Conner CEO / President and the Associate Conference Chair was Ms. Mary Beth Bassett VP of Quality Management and Regulatory Affairs.

A broad range of topics were discussed at this years meeting that included the following: -Strategic Alignment to Achieve Compliance -Managing Risks Using FMEA -Outsourcing, Compliance Risks - Adverse Reactions in Recipients and Donors -Human Error, “Human Factor” -FDA Hot Topics -Registration and Licensure -How to Obtain Licensure -Managing Changes to Licensure -Exceptions under 640.120

A workshop approach was incorporated into this year’s meeting which received positive responses and interaction. The workshops included the following topics: -Deviation Management -Auditing -Training -Quality -Validation -Competency -Implementation of Change –Product Impact of Failures

This years meeting recognized an increase in first time attendees indicating a shift in our industry’s participants and applicability of new information coordinated by the conference committee chairs.

Quality Source has developed On-Target solutions / programs covering similar topics and material that can be utilized by your organization if you were unable to attend this years meeting. Contact Quality Source today to see how we can support your organizations compliance excellence