Certificate in Results-Oriented Biomanufacturing Regulations
-- ViewingNowThe Certificate in Results-Oriented Biomanufacturing Regulations is a crucial course designed to meet the growing industry demand for professionals with a deep understanding of biomanufacturing regulations. This program emphasizes the importance of a results-oriented approach, ensuring that learners gain the skills needed to excel in this highly regulated field.
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⢠Biomanufacturing Regulations Overview: Understanding the regulatory landscape of biomanufacturing, including FDA regulations and guidelines.
⢠Quality Systems: Implementing and maintaining quality systems that meet regulatory requirements, such as Quality Management Systems (QMS) and Good Manufacturing Practices (GMP).
⢠Design Controls: Establishing design controls for biomanufacturing processes, including design input, output, and verification.
⢠Risk Management: Implementing risk management strategies in biomanufacturing, including Failure Modes and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).
⢠Documentation Control: Managing documentation control in biomanufacturing, including the creation, review, and approval of documents, and document change control.
⢠Change Management: Implementing change management strategies in biomanufacturing, including Change Control Boards (CCB) and change evaluation.
⢠Supplier Qualification: Establishing supplier qualification programs, including supplier selection, evaluation, and monitoring.
⢠Validation and Qualification: Performing validation and qualification activities for biomanufacturing processes, including process validation, equipment qualification, and installation qualification.
⢠Complaint Handling: Implementing complaint handling processes, including complaint intake, investigation, and resolution, and adverse event reporting.
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