Training Accreditations

Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products Biostatistics for Non-Statisticians Clinical Document Management - A Trial-by-Trial Approach to Compliance Clinical Trial Project Management, Phase 1-4 Best Practices CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products Overview of FDA Regulatory Compliance for Medical Devices Effective Document Management for Pharma, Biotech & Medical Device Electronic Common Technical Document (eCTD) Submission Training - US vs EU, with Global Insight European Regulatory Procedures - EMA & National Requirements European Union Regulatory Issues – New Product Development FDA Inspections – What Regulators Expect & How to Prepare GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

Good Clinical Practices (GCP) & Risk Based Monitoring- Understanding and Implementing Current Global Requirements Good Manufacturing Practices Marketing & Advertising of Pharmaceutical & Medical Devices Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Medical Devices: The New MDRs, EU Directives, Guidance, CE Marking and ISO Standard Certifications Basic GMP Training for the QC Laboratory Preparation of FDA Submissions and Communicating with the FDA Preparing the CMC Section for MAAs-IMPDs Preparing the CMC Section for NDAs-CTDs-INDs Selecting and Managing CRO's Technical Writing for Pharmaceutical, Medical Device and Biotech Industries The Drug Development Process from Concept to Market Computer System Validation