ISPE India in collaboration with

Transcription

1 ISPE India in collaboration with Glatt India Engineering Pvt. Ltd. IPS Mehtalia Private Limited Jacobs NNE Powder Systems Group Steris Life Sciences Presents a conference on Current Trends and Development In Sterile Manufacturing Technology Friday April 21 st and Saturday April 22 nd 2017 The Westin Garden City, Mumbai

2 Conference Programme Registration Friday 21st April ISPE: A brief Overview of Current Activities and Future Plans Kapil Bhargav Chairman ISPE India Key note address Life Sciences Sector: Challenges and Opportunities Utkarsh Palnitkar, Partner, National Head Infrastructure, Government and Healthcare; and National Head Life Sciences, KPMG Sudesh Shetty, Partner, Forensic, leads Life Sciences Forensic practice, KPMG to 11.00: Net Working Break Session Presented by Powder Systems Group UK Sterile Microsphere formulations Michelle Frisch Sr. Manager Global Technical Systems Session Presented by Steris Life Sciences 12 to 1.00 Challenges in Stainless Steel Maintenance Richard Chai Technical Service Manager STERIS Corporation 1.00 to 2.00 pm Net Working Lunch Visit to Poster Presentation Poster Presentation Session Presented by Glatt Integrated Process Solutions Sterile manufacturing facilities- Case Study of Large Scale Manufacturing of Monoclonal Antibodies to 16.30: Net Working Break Dirk Steinhauser Vice Head Dresden Engineering office & Sales Glatt Ingenieurtechnik GmbH to Upgrade of facilities & systems : Sterile Manufacturing of Vaccines Case Study of an Upgrade Project Dirk Steinhauser Vice Head Dresden Engineering office & Sales Glatt Ingenieurtechnik GmbH

3 Saturday April 22nd, 2017 Session Presented by IPS Mehtalia to Comparison of Barrier Isolators vs RABS to Net Working Break Session Presented by NNE to Managing Requirements in Process Automation Design Robert L Roy SME Aseptic Filling & Validation IPS Prasanna Vudayagiri Director Automation NNE to Serialization: Global Overview and Trends, Opportunities and Challenges to A quick Introduction of ISPE GAMP India Community of Practice Lars Olsen Global Technology Partner NNE Navaneetha Kannan Chair - ISPE GAMP India CoP Steering Committee to Net Working Lunch Session Presented by STERIS Life Sciences to Current global industry best practices in clean room bio burden control, cleaning and disinfection Session Presented by Jacobs to Design of Sterile Fill & Finish Facility with Isolator Technology to Net Working Break to Announcement of Winner of Poster Presentation Richard Chai Technical Service Manager STERIS Corporation Anil Relan Director, Life Sciences Jacobs Jayawant Pawar Chairman Young Professionals ISPE India to Vote of Thanks A.K. Singal, Vice Chairman ISPE India

4 Speaker Resume Kapil Bhargav Chairman, ISPE India Mr. Kapil Bhargava is M. Pharm in Pharmaceutical Chemistry. He retired as Dy. Drugs controller (I) CDSCO with an overall experience of more than 36 years in enforcement of Indian drug rules, manufacture and testing of pharmaceuticals and as an academician. For many years he was involved in implementation of WHO GMP certification scheme, inspection of Pharmaceuticals and Biologicals. with inspecting agencies from United Nations & European Commission and others. He has been WHO Expert and Advisor on quality of biological products. He has reviewed articles in Pharmaceutical Engineering journal, PDA Bulletin (Europe) and is on the Editorial board of Pharma Review (India) and other journals. He is advisor to few pharmaceutical companies and trade associations in private and public sector. Utkarsh Palnitkar Partner, National Head Infrastructure, Government and Healthcare; and National Head Life Sciences at KPMG Mr. Utkarsh Palnitkar has over 30 years of experience in strategy planning (including India entry strategy), feasibility studies, business and financial modeling, public Private Partnership (PPP) structuring for health sciences, policy advisory, impact assessment studies, investment advisory and promotion, funding, human resources development and investment promotion. He is on the Boards of a number of Life Sciences related trade bodies and chairs committees on policy in India He has been associated with pioneering initiatives such as the country s first and largest biotech cluster Genome Valley, the creation of BIRAC under the Department of Biotechnology (DBT) and the country s first Biotech incubator. He was a member of the committee set by the DBT, which provided its inputs to the Government on FDI in pharmaceuticals. He has led the country s largest investment promotion initiative Vibrant Gujarat Sudesh Shetty, Partner, Forensic, leads Life Sciences Forensic practice at KPMG. Mr. Sudesh Shetty has over 16 years of experience in fraud investigation associated with, joint venture disputes, employee frauds, data theft, data leakage, data breach, kickbacks; damage claims and intellectual property thefts; regulatory compliance like US FCPA and US FDA; computer forensic; client relationship management; project management; data integrity investigation around US FDA, UK MHRA and Health Canada inspections to name a few; and building new technical solutions for clients. His investigations have covered medical device companies, API and Formulation plants, payouts to KOL s and HCP and initiatives around seminars, speaker fees and travel to identify trends between speaker fees vs. business generated among others.

5 Sudesh has been involved in multiple global projects around compliance dashboards or global pharma and med device companies; he is a regular speaker on risk and compliance and has been actively driving Data integrity discussions with Indian pharm companies and has successfully conducted multiple audits in identifying noncompliance around US FDA inspection which is impacting companies in India and China (only other two countries with the highest US FDA approved plants outside of US) Dirk Steinhäuser Vice Head of Glatt GIT Dresden Engineering office Dirk Steinhäuser has more than 24 years professional experience in pharmaceutical projects and biotechnology. He holds a scientific degree in Process Biotechnology from University of Teesside, Middlesbrough, UK and an Engineering Diploma degree from Technical University Dresden, Germany. He has worked for Engineering companies, equipment specialists, in R&D and in pharmaceutical companies (NEBC, Oxyphen AG, Linde AG and Glatt Group). He currently holds the position of the Vice Manager of Glatt GIT Dresden Engineering office, where he is steering Conceptual Design and Front End Engineering for biopharmaceutical projects as well being active in BD / Sales and Contract Management. He was part of the core team of the large scale Biotech project for Monoclonal Antibodies for Hoffmann-La Roche in Basel Switzerland, for which he had lived 2 years in Basel Switzerland. Dirk continuously engages in pharmaceutical education and training and has actively supported ISPE Europe, ACHEMA, Dechema GVC, Pharma+Food (EU), The American Academy of continuing Medical Education, and The Russian Pharma Association with specific contributions on congresses, publications and presentations during the past 20 years. Robert L Roy SME Aseptic Filling & Validation, IPS Roy offers more than 30 years of dedicated professional experience in aseptic products manufacture and advanced processing technologies. Over the past 10+ years he has been extensively involved in the engineering, operations and qualification of a number of isolator systems, and is currently considered to be one of the leading experts in the field. Other areas of expertise include potent material handling and containment, Single Use Disposable technologies, Blow Fill Seal technology, cleaning validation and CIP/SIP systems. He has served in senior level management roles directing global engineering, design and manufacturing teams on fast-track design/build/qualification activities for clinical and commercial scale aseptic fill/finish facilities. Because of this background, he is uniquely qualified to assist clients in the development of business and operating plans for new projects. He is currently serving on the ISPE committee to re-write the ISPE Baseline Guide for Sterile Product Manufacturing Facilities, and frequently presents an FDA training module on isolators and RABS for FDA field inspectors and auditors. Anil Relan Director, Life Sciences, Jacobs Anil Relan, a member of ISPE & PDA, is currently working with Jacobs Engineering as Director Life Sciences for India and Asia. Jacobs is one of largest Professional Services Provider for the Life Sciences Industry globally. With more than 30 years of industry experience in Bio API &

6 Dosage forms, Anil has been associated with Design, Delivery & debottlenecking of number of Sterile Fill & Finish Facilities for companies like Shantha (Sanofi), GSK, Biocon, Akorn, Serum Institute, Reliance Life Sciences to name a few. Prasanna Vudayagiri Director Automation, NNE Prasanna Vudayagiri is an automation engineer and project manager. He has over 18 years experience in the pharmaceutical and biotechnology industries specifically in the areas of control system and computer system validation. His greatest technical strength is in Process Automation Systems Design where he has amassed considerable experience in a wide range of control systems involving DCS, PLC, SCADA, and BAS applications used in Pharmaceutical and Biotechnology environments. He has extensive experience in computer validation ranging from setting up site procedures, co-coordinating validation and 21CFR Part11 projects, performing validation determination, validation planning, supplier audits, testing, and validation reporting through to compliance assessment. He has excellent knowledge on DCS, Batch control (S88), GAMP, cgmp, and MS Windows compliance solutions. Prasanna has lead teams on projects including initial design through to final process of commissioning and qualification. He has been responsible to establishing new business units demonstrating his abilities to coach, guide and mentor other Engineers. Lars Olsen Global Technology Partner, NNE Lars is a Global Technology Partner with more than 25 years of experience from Pharmaceutical Assembly and Packaging. Over the last 10 years, he has been working dedicated with Serialization and Anti-counterfeit protection as Subject Matter Expert within numerous global pharmaceutical companies. Covering roles from initiating Strategy and Impact Assessments trough Scoping and Support with Regulatory Compliance and Packaging Technology/Supply Chain knowledge. Michelle Frisch Sr. Manager Global Technical Systems Michelle Frisch holds two Bachelor of Science degrees, and also maintains a Technical Education Teaching Certificate. She has completed her Masters in Business Administration. She is a member of the prestigious Golden Key National Honor Society. She has presented at numerous ISPE Conferences and International Symposiums worldwide and was the first American speaker to present at an International Pharmaceutical Symposium in Japan. Michelle worked for Boise State University as a program manager, in conjunction with OHSA, establishing/developing OSHA compliance and writing operational/training manuals for external corporations. Along with this she developed risk assessment training for blood born pathogens and high-risk environmental exposure. Her articles have been published in Pharmaceutical Technology, Manufacturing Chemist, just to name a few. Michelle has been working with the pharmaceutical industry for over 20 years, specializing in high containment technologies. She is a member of the American Institute of Chemical Engineers, American Industrial Hygiene Association, AAPS, SBE, ISPE, and is on the Standards Committee for the American Glovebox Society. Michelle has also served on the subcommittee for COP for ISPE.

7 Navaneetha Kannan Chair - ISPE GAMP India CoP Steering Committee Navaneetha Kannan is a passionate, dynamic and motivated Pharmaceutical Industry Leader & Chair - ISPE GAMP India CoP Steering Committee with 24 years of Life Sciences crossfunctional business operations experience in diverse areas. Strategic leader who is responsible for all the IT programs in the regulated environment are being managed without compromising on the schedule, scope, cost and regulatory compliance across Software Development Life-Cycle. He is currently working for AstraZeneca as the IT Quality Management Director - Asia Pac Region. He is leading the IT Quality & Compliance activities across all the Manufacturing and R&D sites within the region including the Global Technology Centre/Captive Centre in Chennai, India. He has Masters degrees in Chemistry & Business Administration. He is a PMI certified PMP (Project Management Professional), Lead Auditor - ISO 27001, successfully completed the Mastering Project Portfolio course from Stanford University.