ispe india annual conference 2020

April 17 & 18, 2020 - Mumbai , India

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Advances & new Frontiers in Sterile MFG technology

ISPE India Sterile Manufacturing Conference

ISPE India is excited to present 2020 annual conference in Mumbai, India to discuss advances & new Frontiers in Sterile Manufacturing Technology. 

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.

  • The main focus of the conference will be novel techniques, equipment and technology, including the single use technology for commercial manufacturing which are constantly evolving and which are improving aseptic production capabilities. 
  • The second focus area will be the European Medicines Agency’s Annex 1 so as to have a common understanding of the right approach in its implementation , understand exactly  what is required and its implications on microbial monitoring. 
  • The third focus area of the conference will be highly potent/toxic products, which demand more stringent requirements for cleaning in multi-product facilities to prevent cross-contamination and provide occupational safety for the operators. 
  • The fourth focus area of the conference will be rapid microbiological testing which can enable us to get product test results faster, allowing us to make the most appropriate decisions about our batches, saving valuable time and ensuring that product can reach the patient as quickly as possible while still assuring safety.
  • Other area like energy efficiency of the Heating, ventilation and air conditioning (HVAC) which within regulated environments is typically responsible for consuming up to 40-80% of a site’s total energy will also be discussed.  

subject matter experts will discuss following topics

What has changed in Annex 1 - It's implications & Challenges for Sterile Manufacturing

HPAPI Production Suite and Lyophilization Processes- Critical Design considerations & Qualificatio

Low Endotoxin Recovery (LER) – Facts and Myths Explained

Rapid & Alternative Testing Methods – How to Implement quality & data integrity in a Modern Lab

Microbiological Implications of the EU Annex 1 Revision -


Single-use systems for commercial drug production: Navigating the evolving regulatory expectations

Proper Use of Extractables Data for Single Use Systems – Aspects Beyond Measurement

The current state and future perspective of integrity testing of Single Use systems

How to Manage Clean Room Cost - Quality and Environmental Sustainability without compromises

FDA citation trends with respect to Sterile Product Manufacturing

Automation in Sterile Processing

Data based approach to Continuous Control Strategy and Real-Time Release

Challenges in Implementing New EU GMP Annex 1 Draft requirements for sterile manufacturing -

How to make QRM of Aseptic Processing Better

Data Management throughout the Monitoring of a Sterile Manufacturing Environment

Pharmaceutical Product Quality: Visual Inspection

Technology Transfer Essentials for Bio Pharmaceuticals

Approaches to Regulating Innovation: Industry Perspective on CMC Challenges and Opportunities

USFDA Inspectional trends related to smoke studies and points to consider