Good Engineering Practices in Projects

Good Engineering Practices in Projects

On 06/18 at 2 pm Paulo Jolkesky, our engineering manager, who has 21 years of experience with projects will talk about main concepts of Good Engineering Practices in Projects based on the ISPE Good Engineering Practices guide, with a focus on Defining limits and...
Biopharmaceutical Manufacturing Facilities

Biopharmaceutical Manufacturing Facilities

  Main aspects related to good practices in biotechnology plant projects based on the ISPE Baseline guide – Volume 6 Biopharmaceutical Manufacturing Facilities:Main aspects related to good practices in biotechnology plant projects based on the ISPE Baseline...
New ANVISA Guide Computer System Validation

New ANVISA Guide Computer System Validation

   New ANVISA Guide Computer System Validation We will synthesize the main changes of the new CSV Guide from Anvisa with the previous version, the new guide is more overarching, describing a complete CSV life cycle and detailing the application of Risk Analysis...
Maturity Model – Towards Industry 4.0

Maturity Model – Towards Industry 4.0

WEBINAR   Many companies recognize the role of technology in increasing productivity and quality within their processes. Industry 4.0 is a common goal, as everyone will need to be more competitive in the near future, but how do you get there? It is in this...
Risk Analysis

Risk Analysis

  We will approach the roles of a Risk Analysis: Focus: Systems Validation and Equipment Qualification; What are the bases for carrying out a Risk Analysis; What needs to be validated; Establish the test acceptance criteria; Define essential rules for the...
Good Practices of Procurement in Projects

Good Practices of Procurement in Projects

Good Practices of Procurement in Projects Main aspects related to Good Practices of Procurement in Projects based on the ISPE Project Management for the Pharmaceutical Industry guide: Strategy Planning Supplier Qualification Competition Equalization of Proposals...