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Medical Devices (includes In Vitro Diagnostics)
Applied
Mindy McCann
Vice President Regulatory Compliance
Qserve Group Inc. - ENTERPRISE
Sharon Murphy, MBA
Senior Director Regulatory Affairs
Hologic, Inc.
Participants will hear from speakers what key changes were required in their quality management systems. This will include methods used to assist in ensuring processes were adequately linked together, and processes followed to ensure the requirements were met in a practical and effective manner. Speakers will provide an overview of specific existing procedures that may need to be part of the update, what to look for when reviewing those procedures, and what other processes should be considered.