- 10th December 2021
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7718843607
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Overview
For every biopharmaceutical company, attaining quality assurance throughout the manufacturing process is of utmost critical importance. From managing SOPs to work instructions and specifications, nonconformances to CAPAs, audits to change controls and customer complaints; there is a need for Quality Management Solution (QMS) for the streamlined and effective production process. The highest functioning quality programs integrate their quality management and document control processes. By doing so, they maximize the effectiveness of both solutions, widen transparency and create stronger collaboration around quality. Real value comes when companies manage all quality control processes in one QMS solution to provide a single source of truth for quality and support real-time collaboration for a growing digital workforce and ecosystem.
Excellence through quality & compliance is one of the core values every biopharmaceutical company has to strive to achieve consistently across all functions to ensure high standards. Incorporating leading edge quality management technology helps these companies go to market faster while minimizing product risks and ensuring compliance as a top priority today. Keeping that in mind, this webinar will help you understand the future of digital quality, compliance and operational excellence for the biopharmaceutical industry to help you take more efficient and effective decisions.
Speakers
Ramakrishna Parsekar
Deputy General Manager
Global Application Head, Wockhardt Ltd.
Ramakrishna Parsekar
Deputy General Manager
Ramkrishna Parsekar is a Mechanical Engineer and Post graduate Industrial Engineer from Goa College of Engineering. During his post graduation he worked on “Profit Optimization through flexible revenue management models in travel industry”
After having spent 10 years in Teaching Engineering students and building a Production Center through a India wide World Bank Project, he decided to enter into the world of industry through Global Certification in Procurement through SAP-ERP from SAP-AG Germany.
Subsequently he joined the Pharma MNC Wockhardt in Global Information Technology Department and served as a Project Manager in several mission critical projects in US, UK , France, Ireland , Dubai and India. These projects involved extremely complex technology innovations and fundamental transformations in organisational culture.
He currently heads the GxP and commercial applications for Wockhardt globally that includes IT systems for Quality, Manufacturing, Automated Warehouses, R&D, Clinal Studies and Regulatory department as well as Logistics Finance, Sales and Marketing.
He holds the prestigious PMP and Scrum Master certifications in IT Project Management.
He also specialises in Statutory and Regulatory compliances in IT systems.
He has been speaking in various forums on the Role of Digital and IT in Pharma Quality.
Ramakrishna is an Indian classical Vocalist and holds an MA in Hindustani Classical Music.
Ashutosh Mittal
Head Global Quality Digital & Program Leader
Digital Transformation, Biocon Biologics
Ashutosh Mittal
Head Global Quality Digital & Program Leader
With 20+ years of experience in leading roles for business services, quality has always been at the core for Ashutosh. He is currently the Head of Global Quality Digital Team and also leads the Digital Transformation for Biocon Biologics. Prior to this, he was spearheading Corporate Quality including Quality Management Systems, Vendor Qualifications and Medical Devices for Biocon Biologics.
He has also worked in key roles such as with Research and Manufacturing of Medical Devices with Kalam Institute of Health and Technology (Project by Govt. of India), with Stryker India as Director of their Business Unit and as Head of Quality at Philips.
Biocon Biologics embarked the Digital Transformation Journey in 2020 with the Electronic Quality Management System successfully launched as the first Digital Project. Multiple Digital Projects have been successfully launched at the organization in the past year and many more are in the pipeline.
Ashutosh is leading digital strategy for the organization to bring transformation through lean & AI Methodology, creating a benefit to the business, ensuring continuous improvement and a culture shift.
He believes in transforming the systems at the organization, moving to entirely paper-less laboratories. This will help mitigate all risks of non-compliance & embark a journey of ‘Right, First Time’. Ashutosh would like to create an environment fostering Quality Excellence beyond compliance at Biocon Biologics.
Amit Guru
Regional Director
Solution Engineering, APAC, Sparta Systems
Amit Guru
Regional Director
Amit leverages his wealth of subject matter expertise in quality systems, enterprise software deployments, computer software validation 4.0, regulatory compliance, audit, IoT, Pharma 4.0 & compliance, risk management, validation & qualification and the life science industries to support ongoing sales enablement and services efforts in India and the Asia Pacific region.
Amit has worked in various organizations like Ranbaxy, Sunpharma, Cipla, Strides, Merck etc and having over two decades of experience Manufacturing, Research, QA, QC of Pharmaceutical/ Medical Device Industry, IT Project Management, Leadership, Strategic Business Management, GxP Software Implementation etc. He believes in transforming the systems at the organization, moving to entire paper less, connected, integrated system where data can be transformed into wisdom.
Who Should Attend :
President, VP, AVP, Director, Head, General Manager, Manager from –
- Auditing
- Quality Control
- Quality Assurance
- IT Quality
- Regulatory Affairs & Compliance
- Corporate Quality
- Data Integrity
- Clinical Quality
What You Will Learn :
- Simplify Quality Management
- Identifying common challenges and risks involved & how to drive solutions that bring optimum results
- Increase efficiency through seamless collaborations
- Innovative technologies that enable proactive quality
- Understand Intuitive Quality – Everything you need at your fingertips
Register Now
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