US-based online compliance and regulatory learning solutions company Underwriters Laboratories (UL) Eduneering, which trains drug regulators to ensure safety of FDA related pharma products, is contriving to provide leading Indian pharma companies on maximizing compliances related to consent decree, Form 483, data integrity and quality management systems. This would also help in maintenance of electronic records for inspection readiness of Indian companies.
US FDA Commissioner plans to conduct multi-year capacity building workshops in India for domestic regulators to understand US FDA standardised processes of GMPs and cGMPs in drugs and medical devices segment.
For the fast growing life science community in India, UL and US FDA have also extended their Cooperative Research and Development Agreement (CRADA) for five additional years, extending the agreement till 2019 to serve compliance and regulatory needs of this sector. This CRADA agreement is extended to deal with the training needs that include topics related to international inspections, import and export of products that fall under US FDA purview and intra agency and intra government cooperative agreements. It also involves access to the FDA’s Office of Regulatory Affairs online curriculum via Compliance Wire, which is UL EduNeerings cloud based learning platform.
It is designed particularly for Indian life science industries, to help in audit readiness for training records while being fully secure and complies with US FDA’s electronic signature governance requirements. It provides SOP management, adapts well to the strategic agility of the growing business needs of the organizations.
Mr Vinod Arora, Principal Advisor, IGMPI
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