A Whole New World Opened Up!

“You don’t understand anything until you learn it more than one way.”?— Marvin Minsky

That learning in more than one way began with Case Studies, and did it surprise everyone? It turned out to be a befitting way to open the doors to that whole New World that lay beyond. The World of Supply Chain Resilience overlaid on Quality Management Maturity! PDA - Parenteral Drug Association has been at the forefront of bringing the science, regulations, and people together for over 7 decades now! The PDA India Chapter's tribute to this spirit of sharing was embedded in this 1 + 2-day event, held in Bangalore for a small group of passionate participants.

While all of this began with scepticism, as we progressed, the energy levels, on a virtual mode, were palpable! Near-miss episodes of planning never became showstoppers. The team that kept pushing and participating in meetings, although they were a handful, the activities kept rolling, like a relay baton that went around from team member to team member!

The specific topics covered were picked off the Quality Management Maturity expectations from the US FDA. Leading the sessions were Jennifer Huntington, Nandini Rakala, Ph.D. & Eric Twum, for all medicines, while Carmen A RODRIGUEZ HERNANDEZ from World Health Organization added the perspectives to vaccines. Mr.Rajshekar, CDSCO added his perspectives from the Indian context. A huge shout-out to the line-up of other speakers and panel members/leaders who journeyed to teach-speak-unlearn and relearn with such enthusiasm! Anil Sawant Rustom Mody Greg Smith Ramrao KVS Dr. Ranjana Pathak Srivathsa Yajaman Denyse Baker Ravi Menon Sandeep Raktate Krishna Venkatesh Abhay Kumar Srivastava Pravin Kulkarnni Mayilvahanan Vijayaraghavan Emabelle Ramnarine Jignesh Vora Samantha Atkinson Chella Pandian Pitchai Sreenath N S Ran Bahadur Singh David Talmage Yogish Arora Anshul S.

Participants came from all walks and verticals of the industry! That maiden effort has certainly set a new expectation, where moving the needle from "Why am I required in a PDA event" to "How can I help support this initiative" has not been an easy task, but been a gratifying one, for all of us involved in the Planning Committee! Abhay Kumar Srivastava Bhaskar Krishna Arumugam Constance Richard-Math Dhruv Shah Geena Malhotra M. Gopi Reddy Greg Smith Indrajit Bose Jacquin Jones, DHSc, MS Krishna Venkatesh Michael Cutter Niraj Mehta, PhD Ravi Menon Dr. Ranjana Pathak Reem Malki Vishal Sharma

The lines of open communication between the regulatory agencies and the regulated have been a benchmark, too. There were not many among the audience, who held back because learning that the initiative for Supply Chain Resilience emerges from the maturity of the management of quality, not just at the manufacturing/operational line, but between the two ears of just every individual engaged in this industry was crystal clear. That effort seems daunting! That anyone could do it alone is unthinkable, but, when it becomes a movement, it can and will be actualized/accomplished. Cheers to that spirit and resolution!

Listening to the concept of building resilience by pivoting at the supply chain level, the necessity to bring the quality mindset at every level, and its executable structure from the practice areas as outlined by the speakers/panel members, the tea-lunch-coffeee breaks were encouraging and motivating! What we heard from the regulators, the industry, and service providers was gratifying! The spells of silence also meant a great deal! Jugalbandhi (entwined twins) was the only way neutrality could be woven in, and all moderators did more than that with each of the speakers, and each panel member while balancing the deliberations!

Kudos to the team efforts, the hard work from the sponsors, and bringing a whole new world to each of us!

Learning-Unlearning-Relearning happened in so many ways for this India Chapter Event, because we had a 350-degree camera span and nearly 170 pair of eyes viewpoints! That last 10 degrees remain to be factored in!