Advanced Certificate in Biopharma Validation and Qualification
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⢠Fundamentals of Biopharma Validation and Qualification: An overview of the key concepts, principles, and regulations related to biopharma validation and qualification, including an introduction to process validation, equipment qualification, and cleaning validation.
⢠Regulatory Requirements for Biopharma Validation: A detailed analysis of the regulatory requirements for biopharma validation as set forth by the FDA, EMA, and ICH, with a focus on cGMP, GAMP, and Annex 15.
⢠Process Validation in Biopharma: A deep dive into process validation, including design, execution, and reporting of process validation studies, as well as an examination of the different types of validation studies, such as prospective, concurrent, and retrospective validation.
⢠Equipment Qualification in Biopharma: A comprehensive review of equipment qualification, including the different types of qualification (e.g., DQ, IQ, OQ, and PQ), the qualification process, and the documentation requirements for equipment qualification.
⢠Cleaning Validation in Biopharma: An in-depth examination of cleaning validation, including the different types of validation studies, the validation process, and the documentation requirements for cleaning validation.
⢠Computerized Systems Validation in Biopharma: An overview of computerized systems validation, including the regulatory requirements, the validation process, and the documentation requirements for computerized systems validation.
⢠Advanced Topics in Biopharma Validation and Qualification: An exploration of advanced topics in biopharma validation and qualification, such as risk assessment, continuous process verification, and process analytical technology (PAT).
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