Manufacturing , Quality & Compliance Conference 2023
The Pharmaceutical industry in India is the 3rd largest in the world in terms of volume and14th largest in terms of value. The Pharma sector currently contributes to around 1.72% of the country’s GDP. India has the second-highest number of US FDA approved plants outside the US. India is the largest provider of generic drugs globally.
Since 2005 ISPE India has been at the forefront to bring Subject matter experts to discuss technological, regulatory, quality and compliance advances and latest trends for the benefit of Pharma Professionals. ISPE India is excited to present 2023 annual conference in Hyderabad, India to discuss advances & new Frontiers in Manufacturing Technology, Quality and Compliance.
The event this year will bring some key international experts representing Pharmaceutical and Bio pharmaceutical Industry to take a look at Technological Innovation, Emerging Global GMP regulations, current industry standards and some exciting new approaches to meeting product quality requirements.
One of the focus areas of the conference will be the European Medicines Agency’s NEW Annex 1 to have a common understanding of the right approach in its implementation, understand exactly what is required and its implications on microbial monitoring. We will have subject matter experts who have been associated in shaping the Annex 1 present on Contamination control strategy, what has changed for Sterile processing and for Aseptic Manufacturing.
The second focus area will be Quality & Compliance. We will have several sessions dealing with current challenges in Quality Systems. We will explore how to build pharmaceutical quality systems with a sustainable quality culture and meeting all necessary compliance requirements internationally. We will look at the critical role played by professionals actually working on the shop floor and labs and how their attitude toward quality is shaped by the management of the company. NEW We will discuss guidances released by FDA , ICH and other agencies for cGMP's; delve into challenges in process validations and cleaning validations, innovative ways to implement process control , Qualifications and good engineering practices.
The third focus area will be Innovations in Analytical and Manufacturing Technology- Automation in analysis and Manufacturing, Continuous Manufacturing , Single use technology for commercial Manufacturing which are constantly evolving, and which are improving analytical and Manufacturing capabilities.
The fourth area we will focus on is Critical Utilities Technological and technical progress have increased in the pharmaceutical industry in the last decades. Progress has not only been made in the area of production equipment, technology and quality control but also in the area of auxiliary systems such as HVAC , PW , WFI , Compressed Air and Steam. We will have presentations on advances and recent inspection trends.
The fifth focus area will be Good Engineering Practices. The session will focus on the main principles and application of Good Engineering Practices. We will have presentations by experts covering the steps that are necessary to achieve a continuous state of GMP compliance through correct operating practices, as well as the correct documentation practices and the correct practices to demonstrate compliance.
Finally we will have First Hand FDA Perspective. We will have Ex FDA personnel who have extensively worked in India share their perspective and Experience and the USFDA has been invited to speak as well.
For sponsorship opportunities contact Uday Shetty at shettyuc@outlook.com