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Michelle Paganini, CQA
With over 25 years of corporate experience in the Medical Device field,
Michelle Paganini has made her mark in all aspects of training and auditing
programs, and quality systems evaluation and improvement.
Experienced in both FDA Regulations and ISO
Standards.
Ms Paganini has hosted numerous agency audits, including ISO certifications.
She is experienced in improving and developing
quality systems for both
large, established corporations and start-up companies, including
domestic
and international operations. She has also worked with Pharmaceutical
companies
to develop cGMP training.
Ms Paganini knows medical device systems from a broad based perspective,
developing her career first in manufacturing, then in a production lab, and ultimately
in production control as a planner and master scheduler before focusing on
quality assurance.
Michelle's Resume
Michelle's Bio
Clients and Colleagues recommend Michelle Paganini...
"The training materials Michelle developed and
delivered in the area were thoroughly researched and well organized, both
critical attributes for keeping our workforce up-to-date in a highly regulated
field. These materials and the training itself were a key element of a
successful regulatory inspection which followed the training."
-- Frank Matarrese,
Sr. Director
Corporate Regulatory
Compliance, Chiron Corporation, Emeryville,
CA