The Truth about Serialization and Brazilian Regulation
Manufacturers need to move forward with their serialization and traceability initiatives. Recent modifications in Brazilian regulations have misled many pharmaceutical manufacturers and contract packagers who believe that “they are off the hook” when in fact, Anvisa is moving to tighten the system and finalize the timeline.
Optel, Montesino and Sindusfarma are working together to create this special joint webinar to discuss how to interpret Brazil’s regulatory system, review important RDC details, and provide helpful suggestions on how to manage serialization implementation process.
- Understanding new regulations and deadlines
- Defining the impacts of serialization in Brazilian packaging lines
- How to effectively manage this process to comply
Peter Schmitt, Managing Director and Co-Founder at Montesino
Mr. Schmitt began his career in the early 1980s by selling various types of polymeric raw materials (film, sheet, and synthetic resin) to the medical, pharmaceutical and electronics industries in Puerto Rico and throughout the Caribbean. In 1996, he founded Montesino Associates, which provides consulting services to the healthcare packaging industry in regulatory, technical, M&A and marketing areas. And in 2000, he founded Montesino Technologies, a manufacturers’ representative for high technology film and converting equipment.
Jair Calixto, GMP and Audits Manager at SINDUSFARMA
Mr. Calixto is the Manager of Good Practices and Audits at SINDUSFARMA – Pharmaceutical Industry Association of the State of São Paulo. In his position, Mr. Calixto works with SINDUSFARMA members to discuss and diffuse all new knowledge relating to Brazil’s ANVISA and has published technical publications on Qualification, GMP, Stability study, APIs, and Excipients. Prior to joining SINDUSFARMA in 2008, Mr. Calixto spent 28 years working at pharmaceutical companies and 13 years in private pharmacies.
Jean-Pierre Allard, Chief Technology Officer at Optel
Mr. Allard’s nearly 20 years’ experience in vision and electronics and a decade-long focus on the pharmaceutical industry have made him a recognized expert in global serialization. A founding member of the Open Serialization Communication Standard, Mr. Allard is currently Chief Technology Officer for Optel, where his main role is to lead the company’s general technological direction. Jean-Pierre Allard holds a bachelor’s degree in electrical and electronics engineering from the University of Sherbrooke.
Giancarlo Fusaro, Sales Director ─ Latin America at Optel
Mr. Fusaro has 15 years’ experience working with global, multinational customer organizations. During this time, he developed in-depth knowledge of Latin American markets and customer needs. In his current role at Optel, Mr. Fusaro helps pharmaceutical customers in Latin America establish their specific needs and personalized solutions for their serialization implementation projects. Giancarlo Fusaro holds a degree in engineering from Escola Politécnica da USP and an MBA from Fundação Getúlio Vargas, both in Brazil.