Gain a fundamental comprehension of technology transfer in the pharmaceutical industry, including the transfer of analytical methods, quality control standards, packaging components/operations, and various dosage forms from R&D to manufacturing. This course provides an overview of scale-up and technology transfer of solid dosage forms, injectables, and semisolids.
During the course, we will delve into the challenges of transfers within and outside a company, including transfers to/from international sites and third parties. Best practices to avoid common pharmaceutical technology transfer issues will be discussed.
We will address issues affecting changes to batch size, formulation, packaging components, site of manufacture, manufacturing process, analytical methods, specifications, and processing equipment changes, with practical examples from experienced speakers.
The importance of technology transfer teams and the roles and responsibilities of project managers and team members will be emphasized.
Additionally, you will engage in interactive case studies, based on real-world examples, to develop collaborative strategies and plans to execute complex transfers with short timelines. The course is designed for professionals involved in technology transfer of prescription (innovator and generic) and over-the-counter drug products.
Upon completion of this course, you will be able to:
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This training is designed for professionals in the pharmaceutical industry. It will be especially valuable to personnel and management, including senior management, in these areas:
You will benefit by gaining a better understanding of the complexities of technology transfer in the pharmaceutical industry. The course covers transfers of small molecule drug products, not biotechnology, vaccines, or medical device products.
Mukund (Mike) Yelvigi
Principal and Managing Partner, Center for Pharmaceutical Integration, LLC
Mukund (Mike) Yelvigi’s Courses
Walter G. Chambliss, Ph.D.
Professor Emeritus and Research Professor Emeritus, Pharmaceutics and Drug Delivery, University of Mississippi
Walter G. Chambliss, Ph.D.’s CoursesWhen you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
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