The inherent complexity and uncertainty of biotechnology makes developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using FDA's new Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products.
This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. In addition, the course identifies the long list of activities required to validate biopharmaceutical processes.
Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes, and the regulatory requirements for their validation.
In addition to classroom lectures, participants will take part in several interactive exercises, solve group problems, and participate in class discussions to understand the underlying principles behind Process Validation.
This is an advanced course. Participants should have a basic understanding of commissioning, qualification and validation and basic familiarity with biotechnology manufacturing processes and unit operations.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
This training course is of particular interest to existing and future members of the ISPE Biotechnology and Process/Product Development Community of Practice (COP).
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.
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