Pharmaceutical Regulatory Courses

CfPA offers numerous Pharmaceutical Regulatory Courses:

• Adverse Drug Event Monitoring and Reporting
• Annual Product Reviews (APRs) for Pharmaceuticals
• Auditing and Inspecting Clinical Research in the Global Environment
• Auditing and Inspecting Preclinical Research for GLP Compliance
• Auditing for GMP Compliance
• Change Control/Deviation
• CMC Submissions in CTD Format
• Conducting Effective Quality Audits
• Developing and Managing Complaint Procedures for Medical Devices
• Documentation Management and Control in the Pharmaceutical and Related Industries
• Drug Regulatory Compliance/Drug Approval and Preapproval Inspection
• Drug Specifications for APIs and Drug Products
• EU Regulations, Label and Leaflet Technology for Pharmaceutical Packaging
• Generic Drug Approvals
• ICH-Q7A
• Labeling OTC Drugs
• Laboratory Control System
• The Mechanics of Preparing INDs and NDAs and FDA Regulations
• IQ/OQ/PQ
• Pharmaceutical Quality Assurance and Control
• Pharmaceutical Production and QA/QC Records and Reports
• Preparing for and Surviving an FDA Inspection
• Quality System
• Registration of Pharmaceutical Products in the European Union
• Root Cause Investigation for CAPA
• Scale-Up and Post Approval Changes Guidelines (SUPAC & BACPAC)
• Selecting & Managing CROs
• Surviving an FDA Inspection – FDA Inspections of Non-U.S. Sites
• U.S. FDA Regulatory Compliance
• Vendor and Contract Supplier Qualification
• Writing and Implementing Clinical Protocols in the Global Process of New Drug Development

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