Technology Transfer

Dr. Ajay Babu Pazhayattil, Pharmaceutical Consultant, Toronto, CanadaDr. Ajay Babu Pazhayattil is a highly experienced pharmaceutical professional with a strong background in industrial pharmacy and executive management. He has a track record of driving innovation for brand, generic, and CDMO pharmaceutical organizations. He is known for his data-driven, regulatory-compliant approach to formulation and is well-respected in the industry. He is actively involved in industry organizations and is recognized as a thought leader in the field, having made significant contributions through published journal articles and textbooks. Sanjay Sharma, Senior Vice President & Head Manufacturing Science and Technology, ZydusSanjay is a seasoned pharmaceutical industry professional with over 23 years of experience in the development, launch, and maintenance of drug supply. He possesses a results-driven approach and a deep understanding of pharmaceutical manufacturing science, which has enabled him to contribute to the success of some of the largest organizations in the industry. Sanjay has held various leadership positions in Indian and multinational pharmaceutical companies such as Cipla, Dr. Reddy's Laboratories, Sandoz, Watson, Torrent, and Lupin. Joe Paul Philip, Joe Paul Philip, Vice President & Head, Global Process Excellence and New Products, Glenmark PharmaceuticalsJoe Paul Philip has over 20 years of experience in Technical and Strategic Leadership roles, specifically in Life Cycle Management of Formulations. He has experience leading multicultural teams globally and expertise in Process Development, New Product Launches, Technical Services, R&D Technology Transfers, Global Technology Transfers, Process Validations, Computer System Validations, Equipment Qualifications, Technical Investigation, Root Cause Analysis, and Data Analytics for OSD, Parenteral & Semi-solid technology platforms. He also has experience and knowledge in negotiating development/commercial agreements. Michelle Gischewski-Silva, Scientific Advisor, Eurofins Alphora, Alphora Research Inc As a highly experienced and accomplished leader in the pharmaceutical industry, Michelle brings a wealth of knowledge and expertise to her role. With a solid background in critical new product development projects, she possesses deep technical knowledge in R&D formulation development, scale-up, process validation, and technology transfer of solid and liquid dosages. As the head of the formulation, she was responsible for optimizing formulations and streamlining processes to ensure robustness. Marzena Ingram, Senior Consultant, Validant Inc.Marzena Ingram is an experienced independent senior pharmaceutical consultant who specializes in quality and technical operations for solid-dose and active pharmaceutical ingredient manufacturing. She helps clients address FDA warning letter scenarios. She has developed a specialized team for continued process verification. She has also implemented programs to meet global regulatory requirements, developed and published statistical tools for pharmaceutical manufacturing processes, and led the implementation of a comprehensive life cycle management software. Marzena is a board member of ISPE Canada.

• ​Chapter 1: Current Status of Technology Transfer.- Chapter 2: Quality by Design (QbD) Process Design.- Chapter 3: Quality Risk Management (QRM).- Chapter 4: Technology Transfer Process.- Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies.- Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management.- Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products.