Michele Simone

Dr. Michele Simone is Director of Corporate Quality Management for Bracco Suisse SA in the pharmaceutical imaging product operations in Lugano, Switzerland, where he is responsible for Quality Management Review, complaints management, auditing, quality risk management, knowledge management, CAPA management and Continual Improvement. Over 28 years’ experience in the pharma/biopharma industry. Michele hold a number of different roles during his career, including: Microbiology and Environmental Monitoring Supervisor, QA GMP Compliance Site Manager of a sterile fill-finish facility (liquids, lyophilized vials, pre-filled syringes, cartridges), QA/QC Senior Site Manager of a medical device J&J facility (coronary coated stents) with a broad international scope, Global Quality and Training Senior Manager (site and corporate quality) of a Parenteral network of J&J facilities, Head of Quality System and Compliance of a Vaccines fill-finish facility, QP and Quality Unit Head of an API plant, Corporate Quality Auditor for API, Finished products, Chemical, Consumer, Commercial Affiliates, Vendors.

He has lived and worked in Italy and Switzerland and has supported sites in Italy, Belgium, Switzerland and USA.

He has extensive experience organizing/leading competent authority inspections, including FDA, and preparing/conducting GMP training courses also for Training Consultancy firms.

In-depth QA and GxP experience in drug products including parenteral, medical device and vaccines manufacturing and control process. Gained the IRCA certification to lead Pharmaceutical Audits and Self-Inspections. Acknowledgement as “Qualified Person” according to Directive 2001/83/EC for Medicinal products for human use. Michele is an active member of PDA and his membership is close to the 18th anniversary. He is part of Board of Directors for PDA Chapter Italy since 2014. He has served as Secretary in the last mandate. He is currently part of the PDA Regulary Affairs Quality Assurance Board (RAQAB) and he is the Chair of the PDA Interest Group “Quality System”. Michele often serves as chair and lecturer at major conferences in Italy and Europe on topics including quality management, supplier quality management, process continual improvement, quality risk management and knowledge management. He has been part of the PDA Task Force “Remote Audits and Inspections” and he contributed to issue the PDA Point of Consider – Remote Audits and he acted as Reviewer of PDA Point of Consider – Remote Inspections.

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Fri. February 24 | 10.30am – Microbial data investigations and effective implementation roadmap of Contamination Control Strategy

• Microbial data deviations are test results that exceed the established specifications or acceptance criteria in a drug application, drug master file, official compendia, good manufacturing practices, or internally by the manufacturer. This includes, but is not limited to, results generated during utilities monitoring, active principal ingredients, materials, in process control and semifinished product testing as well as during environmental monitoring. The validity of the test results is supported by a documented laboratory and manufacturing investigation. A Contamination Control Strategy (CCS) is a cyclical process designed to prompt the manufacturers to identify and resolve risk.
  A (CCS) should be implemented across the facility to assess the effectiveness of all control and monitoring measures employed by a company. And this is living across the lifecycle of the product/process within an effective Quality Management System.
• This presentation includes a holistic approach for conducting a microbiological investigation. It provides a framework to support the investigation of the root cause of microbial data deviations, focusing on all contributing areas, such as sampling, test methodology, and suitability of the test.
• An effective CCS is a key enabler to ensuring Compliance to the revised Annex 1 GMP.
  The preparation of a CCS is challenging and requires a multi discipline team with full process and scientific knowledge. An effective roadmap planning is needed to ensure an identification and assessment of all key components where Contamination Control applies.