Boston Area Chapter Events Calendar

November 15 Search View Month November 17
November 16, 2017
Title Time Description
RE SHOWING: Focused Trends from FDA: What are they focusing on during their inspection? 5:30 PM to 9:00 PM


Alexion Rhode Island Manufacturing Facility
100 Technology Way, Smithfield, RI 02917


5:30 - 6:30 PM Registration and Networking Reception 
6:30 - 7:30 PM Presentations



Register now for this re-showing of the September 21st event recorded at Shire, hosted at Alexion Rhode Island Manufacturing Facility in Smithfield, RI. A networking reception, including refreshments and appetizers, will occur before the presentation.


Staying up-to-date on the regulatory guidance and health authority expectations is critical for any GMP-regulated organization. With fast growth in technology and changes in how organizations are run, it’s critical to understand the requirements for maintaining regulatory compliance. In this event focused on the FDA, we will hear from a Director of Quality Assurance in the industry. Come to this event to find out the most current perspective on preparing for your inspection, and to learn about upcoming trends in FDA oversight.


Inspection Readiness - The Industry Perspective 
As more and more pharmaceutical companies move towards building their products around contract research, test, and manufacturing organizations, our industry must adapt our understanding of how to operate in compliance with FDA and global regulations when operations are not within our immediate control.  The first presentation of the evening, delivered by Jolly Bhatia, Senior Director of Supply Chain Quality Assurance at Alnylam Pharmaceutials, will focus on current trends in regulatory inspections from the perspective of a CMO-based quality organization.  Jolly will present a case study on inspection planning for a CMO-based organization, and will answer questions on the ever-changing regulatory landscape impacting them.


Jolly Bhatia, Senior Diector, Quality Assurance, Alnylam Pharmaceuticals 
Jolly Bhatia currently works at Alynylam Pharmaceuticals as the Senior Director of Supply Chain Quality Assurance. His responsibilities include quality oversight of manufacturing and supply chain operations, starting from procurement of raw materials to delivery of product to the patient. In his more than 20 years of experience in the bio pharmaceutical industry, Jolly has worked with several internal and contract manufacturing sites, in validation and quality leadership roles, preparing for routine and Pre-Approval Inspections.


After 11/9/17
Members -  $30
YP Members -  $10
Nonmembers - $55
Student Members - FREE 

Alexion Rhode Island Manufacturing Facility, 100 Technology Way, Smithfield, RI 02917

On-line Registration is not available