Professional Certificate in Biomanufacturing Legal Compliance Essentials
-- ViewingNowThe Professional Certificate in Biomanufacturing Legal Compliance Essentials is a crucial course for professionals seeking to excel in the biotech and pharmaceutical industries. This program focuses on the legal and regulatory frameworks that govern biomanufacturing, ensuring learners understand the complexities of compliance.
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⢠Regulatory Framework for Biomanufacturing: Understanding the legal and regulatory environment for biomanufacturing, including FDA regulations, GMP (Good Manufacturing Practices), and other international standards.
⢠Quality Management Systems (QMS): Implementing and maintaining a robust QMS to ensure compliance with regulatory requirements, focusing on ISO 13485 and FDA QSR.
⢠Documentation and Record Keeping: Establishing and managing documentation and record-keeping practices that adhere to regulatory requirements and industry best practices.
⢠Change Management: Managing changes in biomanufacturing processes, equipment, and facilities, ensuring compliance with change control regulations and guidelines.
⢠Complaint Handling and CAPA: Implementing complaint handling and CAPA (Corrective and Preventive Action) processes that meet regulatory requirements, focusing on FDA 21 CFR Part 820 and ISO 13485.
⢠Supplier Management: Managing suppliers and ensuring their compliance with regulatory requirements and industry standards, focusing on supplier qualification, monitoring, and auditing.
⢠Clinical Trials and Data Integrity: Ensuring compliance with clinical trial regulations and data integrity requirements, focusing on FDA 21 CFR Part 11, Part 50, and Part 54.
⢠Inspection Readiness: Preparing for regulatory inspections and ensuring readiness, focusing on FDA inspection processes, 483 observations, and warning letters.
⢠Risk Management: Implementing risk management practices that meet regulatory requirements and industry standards, focusing on ISO 14971 and FDA guidance.
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