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Pharmaceutical Technology Transfer and Regulatory Strategies

 
  February 13, 2020  
     
 
CfPA- The Center for Professional Advancement, Amsterdam, The Netherlands
8-9 June, 2020


Who Should Attend?
This course is intended for individuals from:
  • Innovator, Generic, CMO, CRO and CDMO Companies
  • Formulation and Process Development/Validation
  • Regulatory Affairs, Quality Assurance
  • Analytical Methods Development/Quality Control
  • Package Development/Package Engineering
  • Manufacturing and Technical Support
  • Project Management and Operations Planning

Participants, as well as their managers, 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.

Course Description
This 2-day intensive, accredited course will provide a basic understanding of the technology transfer of analytical methods, active pharmaceutical ingredients, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting transfers within and outside a company. Topics will include transfers to/from international sites as well as to/from third parties. This course will also provide an overview of relevant FDA and ICH regulatory guidance documents including the Scale-up and Post Approval Changes (SUPAC) guidances documents and the Changes to an Approved NDA or ANDA Guidance. The issues affecting changes to the batch size, formulation, packaging components, site of manufacture, manufacturing process, analytical methods, specifications and processing equipment changes will be addressed. Speakers will use practical examples to highlight issues critical to successful technology transfer. Interactive case studies based on real examples will allow participants to develop strategies and plans in a team environment.
 
 
Organized by: CfPA- The Center for Professional Advancement
Invited Speakers:
Walter G. Chambliss, Ph.D., Professor and Research Professor Emeritus, Pharmaceutics and Drug Delivery, University of Mississippi

Walter G. Chambliss, Ph.D. is Professor Emeritus of Pharmaceutics and Drug Delivery, and Research Professor Emeritus in the Research Institute of Pharmaceutical Sciences at the University of Mississippi. He teaches graduate courses in pharmaceutical formulation development, manufacturing and regulatory sciences. He also lectures in the Hands-on Course in Tablet Technology (tabcourse.com), a post-graduate education course. In addition to teaching he managed the technology transfer operations of the university for 20 years. Dr. Chambliss received a B.S. in Pharmacy, a M.S. in Pharmaceutics and a Ph.D. in Pharmaceutics from the University of Mississippi. He worked for 17 years in research and development in the pharmaceutical industry at G.D. Searle, Bristol-Myers and Schering-Plough where he was Vice President of R&D for the HealthCare Products Division. He has extensive experience in formulation development and process development of a wide variety of dosage forms. Dr. Chambliss is a Fellow of the American Pharmaceutical Association and a past-President of the Academy of Research and Science. He has authored or co-authored over twenty publications including three book chapters in pharmaceutical reference books.
 
Deadline for Abstracts: N/A
 
Registration: Please click here for registration information.
E-mail: knee@cfpa.com
 
 
   
 
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