Given the recent US Food & Drug Administration (FDA) scrutiny on Indian pharma companies, US based premier safety science company Underwriters Laboratories (UL), which works to support safety of pharma products globally is planning to guide the Indian pharma industry on compliance to Good Manufacturing Practices (GMPs) through its online compliance subsidiary EduNeering.
EduNeering serves as the online compliance partner for the US FDA, Duke Clinical Research Institute, the Drug Information Association (DIA) and AdvaMed.
Says Kavita Mehrotra, global head, Strategic Alliance, UL (Life and Health division), "We look forward to offer learning solutions to Indian pharma industry through an online education platform comprising of over 700 courses and a validated Learning Management System (LMS). This is an excellent opportunity for us to bring global GMP training standards in a scalable, agile and relevant format to the Indian pharma and medical device market with stronger emphasis."
Designed specifically for life science industry, the LMS called ComplianceWire is built on a Cloud-based model which helps reduce IT and validation costs. Equipped to provide SOP management, it adapts well to the strategic agility of the growing business needs of the organizations. Capable to cater globally in 34 languages, it is also equipped with learning effectiveness suite and robust reporting tools to ensure audit readiness and management visibility.
The system helps in audit readiness for training records while being fully secure and complies with US FDA’s electronic signature governance requirements.
UL has a long standing relationship with US FDA and has trained over 30,000 FDA inspectors. "As a statistical testament to our product leadership in this area, in 2013, we recorded 23 million training completions by our global audience, with four hundred clients in pharma and medical device area and government agencies," she adds.
Using technology as a tool to provide the right training to the right people at the right time, UL is recognized in the industry for subject matter expertise in Global manufacturing practices (GMP), 21 CFR 11 Chapter 21 compliance, and QSR (Quality System Regulations). It provide regulatory and compliance focused Learning Solutions that enable life science companies to achieve regulatory compliance, minimize organizational risk and improve quality and business performance.