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Journal of sexual and Reproductive medicine | Volume.1, Issue.2
Page 9
Notes:
3rd International Congress on
Annual Summit on
October 02-03, 2017 Atlanta,USA
&
Microbiology and Pharmaceutical Microbiology
Sexual & Reproductive Health
Hope Mueller
Horizon Pharma Inc, Ireland
Quality oversite of CMO’s microbiology investigation
Statement of the Problem: CMO partnerships can be challenging both for the CMO and the product owner,
especially when a significant OOS or other microbiology investigation arises. We will be discussing the CMO
relationship and best practices that will ensure consistent, reliable, and quality supply throughout a difficult
investigation. There are optimal organizational designs for CMO’s and product owners that increase the
likelihood of a successful partnership and outcome of the investigation. Clearly defined roles, responsibilities,
and accountabilities are required. How to take increased action in the event the CMO’s performance is suboptimal
or represents a compliance risk? Establish short term and long-term corrective actions to ensure regulatory
compliance throughout and in response to a critical event. Real world and first-hand examples to be discussed
OOS events in products on stability, facility impacting sterility failure, aseptic processing validation failures, and
critical system events experienced at the CMO. The discussion will instruct the participants how to effectively
partner with CMO to ensure safe and quality product is provided to patients.
Biography
Hope Mueller has over 18 years in Contract Manufacturing or Contract Manufacturing Oversight. She has designed organizations as a Contract Manufacturer and
as a Product Owner. She has experience in the pharmaceutical microbiology laboratory and most of her career was within and managing analytical laboratories.
She has lead large teams ensuring consistent and reliable supply of quality product. She has managed relationships with virtual and big pharma clients, and over-
seen multiple vendors. Hopes expertise lies in quality, operations, and continuous improvement. She has hosted, participated and executed hundreds regulatory
and client audits. She has expertise in aseptic filling, BFS, oral configurations, topicals, inhalants, and biologics. She has proven success in launching efficient
systems and improving operational performance at all levels. She is an exceptional leader proving her skills through the construction, training and mentorship
of highly productive teams.