November 26, 2001 — LOS ANGELES, CA — In an effort to support the biotechnology industry’s robust expansion, UCLA Extension is offering four short courses in biotechnology applications in Winter 2002.
Douglas Stockdale, president and chief technology officer of Stockdale Associates, and numerous guest lecturers from the biotech industry will provide up-to-date information on all aspects of biotechnology product development. The courses will include research and development, product life cycle, customer end-use and disposal, regulatory issues, quality assurance, quality control, manufacturing, and validation.
The courses begin in late February and run through March. Two of the courses are primarily for professionals and managers. Quality Systems for Biotechnology Product Development (February 25 & 26) provides students with a basic understanding of implementation requirements for the various phases of biotechnology product commercialization. Fundamentals of Process Validation for Biotechnology (February 27-March 1) deals with process validations for various biotechnology manufacturing systems.
The remaining courses are introductory courses aimed for a broader audience. Container and Closure Development for Biotechnology and Drugs (March 18 & 19) provides an introduction to primary packaging systems for biotechnology products and drugs, with an overview of the primary package life cycle, regulatory considerations, and current issues for primary package components. Fundamentals of Aseptic Filling for Biotechnology and Drugs (March 20-22) offers a broad operational and technical review of the underlying systems that are required for a successful aseptic filling operation.
Stockdale brings to these courses 25 years of practical experience in product development, technology management, clinical manufacturing, and validation. He has published management and technical papers, presented at international industry meetings, and is a contributing author to the book, Aseptic Pharmaceutical Manufacturing. He is a member of ISPE and PDA.
For detailed information about these courses, go to the UCLA Extension Short