50 Kearney Square, Lowell, Massachusetts
5:30 - 6:30 PM Registration and Networking Reception
6:30 - 8:30 PM Presentations
Register now for this re-showing of the September 21st event recorded at Shire, hosted at Middlesex Community College, Lowell, MA. 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, itâ€™s critical to understand the requirements for maintaining regulatory compliance. In this event focused on the FDA, we will hear from both sides of the compliance dilemma: a Director of Quality Assurance in the industry, and an ex-FDA inspector. 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. Our speakers will participate in a joint Q&A after their presentations for discussion and to answer your questions.
PART 1: 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.
PART 2: Regulatory Developments and Areas of Concern
The FDA continues to issue the most warning letters for rudimentary cGMP issues worldwide, but in this presentation Mark Lookabaugh (ex-FDA, Parexel Consulting) will focus on the most modern inspections trends and issues effecting FDA-regulated organizations. Mark will discuss ongoing issues with data integrity, and provide his most current perspective on which guidance to follow to deal with those issues. Mark will also discuss the FDAâ€™s program alignment initiative and how it may affect inspection schedules, turn-around times, as well as the effects of EU / FDA Mutual Recognition Initiative and Responsible Corporate Officer Doctrine.
Mark Lookabaugh, Principal Consultant, PAREXEL Consulting
Mark Lookabaugh, Principal Consultant, provides GMP and QSR auditing and consulting services to PAREXEL clients worldwide. Prior to joining PAREXEL, he served 30 years with the FDA. His career included work as an Analytical Chemist in the New England District laboratory, specializing in pharmaceutical chemistry. He performed Pre-Approval Inspections (PAIs) in the pharmaceutical and biotechnology industries in the US and overseas. He also served for 8 years as a Compliance Officer in the New England District Office, processing FDA enforcement actions in the 6 New England States. During this period, he managed several medical device cases and gained knowledge of the QSR and MDR regulations. In 2004, he was promoted to Director, Compliance Branch, with responsibility for oversight of all FDA enforcement activities in the New England District. He has published scientific papers in the Journal of Chromatography, and is the recipient of several FDA awards. Mark received a BS degree (Chemistry) with high honors from Worcester Polytechnic Institute, Worcester, Massachusetts.
Early bird, register by 10/26/17
Members - $50
YP Members - $20
Nonmembers - $95
Student Members - FREE
Members - $60
YP Members - $30
Nonmembers - $115
Student Members - FREE
On-line Registration is not available