Michel Raschas

PROGMP SAS
Consulting Validation & Services Director
Michel Raschas is an e-compliance expert and Consulting Validation & Services Director of PROGMP, a consulting, engineering, and validation company. He has an engineer degree and has been working for more than 30 years on information system topics. Michel is a Certified Fellow in Production and Inventory Management (CFPIM) by the American Production and Inventory Control Society (APICS). He provides training for professionals and lectures for major schools such as the Pharmaceutical Master of the University Saclay Paris Sud and the University of Burgundy. He has written reference documents and articles concerning various subjects of computer compliance and industrial and logistical management for the process industry. Michel has been a member of ISPE since 2003 and is Secretary of the ISPE France Affiliate. He is the cofounder of the Community of Practice GAMP® Francophone and he initiated the working groups on serialization and DM UDI for ISPE France.

Related Articles

Medical Device UDI Components Management in the European Union
Technical
Medical Device UDI Components Management in the European Union

Since 2019, the ISPE France Affiliate’s Unique Device Identification (UDI) Medical Device Work Group has been producing tools to help project stakeholders within the EU or overseas understand and comply with EU regulations of UDIs in medical devices. Some of those tools are highlighted in the article.

Serialization model
Features
Ten Frequently Asked Questions about Serialization

To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161 of 2016. Worldwide, other anticounterfeiting regulations are already in place or coming soon in...