On May 8-9, you and your team attended a workshop co-driven by US FDA and CDSCO. What was your experience at the meeting?
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Kavita Mehrotra |
On May 8-9th, I had the privilege of attending workshop held in Goa co-driven by US FDA and CDSCO to learn firsthand about GMP, cGMP, and quality management. Our participation on that workshop was based as an attendee: we wanted to see how the Indian top pharma companies carve their roadmap through the learning in this workshop. Speaking as a long-term online learning partner to US FDA, it was thrilling to see the standardised global learning modules come to life in this very focused workshop, with insightful GMP topics like quality control, process validation, and many others.
As an organisation involved in GMP training, what were your key impressions from the Goa meeting?
I was personally and professionally very impressed with many industry relevant topics covered by the US FDA, as that is completely aligned with our areas of focus and expertise, and we see ourselves as agents of change through training as a vehicle for culture of quality. Also, these topics are timely, in the wake of a torrent of warning letters that Indian pharma companies are receiving, and the full attendance in these workshops is a testament to their desire to strengthen their processes and knowledge. What is exciting for me personally is that all the topics covered by US FDA: OOS, GMP, cGMP, GCP, electronic records, and 21 CFR guidelines are represented and covered in our online suite of modules. This is not surprising, since our content on GMP is authored by US FDA subject matter experts.
In fact, our 21CFR 11 compliant award winning Learning Management System, Compliance Wire, is being used to train US FDA inspectors for over a decade, and we have already trained 36000 inspectors and counting. We take the responsibility of bringing the right training to the right people at the right time very seriously, knowing that ultimately we are answerable to patient health and safety by owning the role of thought leaders on compliance, quality and GMP training in the industry globally.
What is UL’s mission in India and development plan to reinforce these messages from the US FDA workshop?
UL’s corporate mission is to make a safer world, and at UL EduNeering we view the production of quality pharmaceuticals and medical devices as a vital part of making the world safe. We have development teams here, and a large office in Bangalore. Our commitment and plan now is to provide pharma-specific feet on the ground dedicated to advising companies on how to leverage technology to sustain these messages and propagate them within their own organisations. We can also help companies tailor those messages to their specific needs. Additional to our relationship with the FDA, we also have knowledge assets that map to other global regulatory bodies. India is playing a vital role in the global pharma industry, and to be true to our mission we need to be here and be of service to Indian pharma.
We are building effective strategic partnerships with similar minded organisations to reinforce this message of a culture of Quality. For example, UL EduNeering, in partnership with IDMA, is holding a one-day seminar on Roadmap for India pharma in Mumbai in September, where we will bring hand-on knowledge and techniques to help audit proof pharma companies by actionable steps and approaches. We hope to replace fear and anxiety with knowledge, empowering companies to master the etiquette of audit readiness both from a technical and soft skills perspective. And ultimately, provide India with resources that enable companies to reclaim their position in the global landscape.
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