Conference Agenda: Day 1, Friday, 10th August 2018
Day1: Focal Theme
“Quality Culture - Revolutionizing Dynamics of Quality Assurance”
Conference Inauguration & Opening Key Note Address
Topic: Challenge of Quality Culture – Articulation & Development
“A Smart Pharma Manufacturing for Operational Excellence; Latest in Pharmaceutical, Analytical & Lab”
Descriptor: What kind of manufacturing set up is required in pharmaceutical production facility to ensure quality product. What kind of machinery, equipment and other inputs are needed for quality production. How Human Resource is also an essential part of quality assurance and how to deal the HR aspect for quality assurance.
Information technology has already revolutionized every sector and world of work. Automation of all the manual work in pharmaceutical sector, known as pharmacy informatics, is based on the principals of IT systems. There are softwares that aid the smooth functioning of pharma units, improve their efficiency & accuracy and as a result help in improved decision making. Among many other functions pharma companies need informatics for crossing the quality chasm and preventing errors. IT, like in any other field, can also give a boost to quality assurance in pharma.
Any improvement in the machines, equipment and manufacturing processes and introduction of new parameters and bench marks done for quality improvement & assurance involves cost. But not doing it also involves cost, sometimes even more than required for improvements. Not realizing this many a times cost is cited as a reason for not been able to take up the improvements in the systems. But is cost really an hindrance in quality assurance?
“Setting Quality Culture Parameters”
One major lacuna in implementing & popularising the quality culture in Indian Pharma is the lack of mechanism to measure the quality culture outcome. No parameters are yet set for quality culture outcome. Hence, quality culture articulation & development is a new industry challenge. It is of paramount importance to set such parameters for only then the quality culture will become of the manufacturing processes in all pharma manufacturing facilities. The issue of having the calibration of equipment right & precise is also important since any error in initial reading will lead to totally wrong results and diagnosis. Hence, how to know that one has perfect equipment to measure rightly calibrated is also very crucial.
Day2: Focal Theme
Opening Keynote Address:
‘Regulatory & Pricing – A Challenge for Pharma Sector’
Conference Agenda: Day 2, Saturday, 11th August 2018
“A Distant View of Indian Pricing & Regulatory; US Perspective”
“Is Regulatory Compliance much more than GMP?”
Quality culture, regulatory compliance, good manufacturing Practices (GMPs) and cost & pricing of products are all interwoven factors, one affecting the other in some way or the other. Thus this needs to be discussed as the subsequent part of Quality Culture. Among them there needs to bring in clarity over GMPs and mere regulatory compliance.
“Presentation of Case study on Pharmacoeconomics” – 30 mins
Panel Discussion on
“Regulatory, Pricing & Patients – Equilibrium”
Vote of Thanks & Closing Ceremony