Understanding the specific requirements for cGMP compliance with respect to quality assurance, quality control and process optimisation processes

• Learning the latest updates on cGMP requirements to stay abreast with the evolving regulatory policy and development
• Identifying the existing gaps and discrepancies in Indian cGMP guidelines and fulfilling these to meet international standards
• Evaluating various quality control processes , quality assurance requirements and complete regulatory interface to comply with cGMP standards
• Understanding the manufacturing requirements with respect to plant area, equipment and processes to meet international quality and safety standards
• Highlighting the specific documentation requirements with respect to the updated GMP standards to ensure swift and smooth commercialisation of your product
• Case Study: Overcoming specific cGMP concerns raised in the emerging markets and effective strategies to deal with these

• Leveraging the latest developments in fermentation, aseptic connections, control of filters and duration of filters to achieve high quality with maximised yield
• Examining the process changes during scale-up and pro-rata scale-up to ascertain their impact on the overall yield of the product
• Determining the appropriate control parameters required for effective scale-up
• Navigating the complete regulatory landscape of the scale-up process – level 1,2 or 3 and validation of scale-up
• Highlighting success stories in the scada system for fermentation control, on-line pH and DO measurement

• Troubleshooting chromatography and filtration challenges to achieve the desired purity standards
• Establishing the need and importance of product concentration and identify various techniques for effective purification process
• Examining how process changes in scale-up and pro-rata scale-up impact the yield
• Determining the appropriate control parameters required for effective scale-up in the downstream processing
• Navigating the complete regulatory landscape of the scale up process – level 1,2 or 3 and validation of scale-up in downstream processing
• Devising effective strategies to overcome the hurdles faced in the downstream process to ensure purity and high yield
• Exploring best practice case studies on bio-controlled process versus aseptic process

• Outlining the importance of effective technology transfer at different stages in the inlicensing procedures to avoid legal implications and ensure easy access to technical know-how
• Devising effective strategies to ensure smooth technology transfer with respect to processes, testing, raw materials and method of transfer
• Undertaking proactive measures to reduce the time lines and eliminate potential re-work
• Leveraging on the parent product data to ensure its effective usage in pre-clinical and clinical data
• Overcoming specific challenges faced due to different locations, climatic conditions and other environmental problems to ensure smooth and flawless transfer procedures
• Emphasising on the need of appropriate co-ordination between R&D and manufacturing departments to ensure a smooth transfer process
• Analysing a case study on Japanese encephalitis
• Highlighting specific challanges in technology transfer of Hib (Haemophilus influenza type b) vaccine from research to production

• Identifying how VLP vaccines are different to conventional vaccines
• Understanding and overcoming challenges in the clinical development of VLP vaccines to ensure high quality product
• Highlighting the specific benefits offered by VLP vaccines with respect to achieving full biocompatibility and biodegradability
• Determining the most effective techniques for simple purification and quality analysis

• Comparing the benefits of one-time use machines with the regular ones to determine the differences with respect to cost, quality, speed and efficacy in vaccine production
• Determining innovative ways to control the manufacturing costs by continuous improvement in technologies with minimal changes in process scheme to ensure higher product quality

• Understanding the cold chain management requirements for storage and distribution
• Assessing cold chain management needs of vaccines as against other biological products
• Overcoming the challenges of continuous monitoring of in-transit vaccine products
• Finding a cost-effective means of dealing with power cuts and other cold chain barriers
• Developing effective processes to ensure compliance with end-to-end cold chain culture
• Assessing state-of-the-art equipment for cold chain management of vaccines
• Determining the advances in validated packaging systems to identify the best ways to maintain the desired temperature during transit
• Leveraging on the optimisation of design, size and packaging for transportation of vaccines
• Tracking cold chain performance by innovative devices and technology throughout the shipment cycle

• Exploring the most effective cold chain options available for different stages of distribution including manufacturing site, CWH, CFAs, distributors and doctors
• Troubleshooting the maintenance of cold chain at various stages of distribution to determine the most effective and flawless maintenance system
• Analysing the most innovative solutions in cold chain management and understanding their cost and time benefits over traditional systems

• Devising the most cost-effective strategies to ensure consistent raw material supply, the right equipments and the right resources
• Understanding innovative inventory management techniques to reduce cost, maintain quality and ensure timely delivery
• Identifying innovative techniques by predicting market requirements to ensure better inventory management
• Leveraging the latest developments and overcoming specific challenges faced in the 2D bar-coding system and RFID to track and trace the product till it safely reaches the end user
• Understanding with practical examples how to effectively link inventory management with market forecasting to ensure an appropriate demand-supply matrix
• Determining the most appropriate option for inventory management – comparing manufacturing site with CWH and CFAs
• Identifying the need for having a CWH, and it’s contribution towards efficient inventory management
• Establishing the most effective practices followed for maintaining inventory at primary and secondary levels for cold chain sensitive products
• Establishing the co-relation of product life cycle and inventory norms to ensure optimum quality and minimum wastage

• Critically analysing the most appropriate alternative for your company - ‘Pure steam’ versus ‘Clean steam’
• Leveraging the latest developments in water purification systems for vaccines to ensure a clean and safe manufacturing process

• Understanding the specific intricacies of catering to supranational organisations such as the UNICEF and PAHO
• Devising effective strategies to take vaccines to the non-donor international markets with special reference to Non-UN healthcare agency based public markets
• Devising effective strategies to take vaccines to the non-donor international markets with special reference to Non-UN healthcare agency based public markets
• Exploring the best strategies for brand building and direct intuitional supplies to private international markets to ensure swift and wider market reach

Conference Day One | Conference Day Two | Regulatory Focus Day
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