Helping you with compliance success!
Hoinowski Consulting, LLC is an independent consulting firm which provides cGMP assessments, auditing, remediation, training and quality management resources to a wide range of organizations, with a focus on Quality Control/Quality Assurance in the pharmaceutical industry.
A Senior Consultant is well versed in the principles and practices of Quality Control/Quality Assurance. He has CGMP expertise in Pharmaceuticals, Biologics, Medical Devices and Chemical Operations and experience in remediation and verification/certification activities involving Companies in Consent Decree. This includes areas such as Laboratory Investigations, Deviation and CAPA Management, Data Integrity, Analytical Method Validation/Qualification, Stability Programs, Change Control, Quality Management, Quality Systems, Validation, Computer Systems, Technology Transfer, Risk Assessment, Sterile Products, Environmental Monitoring, and Supplier Management /Purchasing Controls.
He has performed various consulting services as team leader of the laboratory section for facility certification, laboratory assessment leader, and laboratory remediation leader for clients, including a number of clients under Consent Decrees. He has been involved in verification/certification activities involving a number of Companies in Consent Decree. He has also assisted several companies with clinical trial drug production/compliance readiness.
Alex worked for 30 years in the Pharmaceutical and Specialty Chemicals divisions at Merck serving as Director of Quality Operations for both the Offshore Operations and Domestic Operations divisions and as Director of Systems Development for Quality.
He has authored the chapter on Laboratory Controls in the Seventh Edition of "Good Manufacturing Practices for Pharmaceuticals", published in 2019. He co-authored the chapter in the Sixth Edition of "Good Manufacturing Practices for Pharmaceuticals", published in 2007. He holds several patents from his tenure at Merck Research Laboratories and has published various articles associated with the pharmaceutical industry such as “Investigations of Out-of-Specification Results" in the January 2002 issue of Pharmaceutical Technology. He has been a presenter at various International Pharmaceutical Academy’s Courses and Workshops on OOS.
Postal address 22 Willowbrook Lane, Annandale, NJ 08801
LinkedIn profile http://www.linkedin.com/pub/alex-hoinowski/9/40a/981
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