| Course Title |
Course Date |
Location |
| Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products |
Jul 13, 2020 - Jul 14, 2020 |
Virtual (EDT), |
| Medical Devices: The New MDRs, EU Directives, Guidance, CE Marking and ISO Standard Certifications |
Jul 16, 2020 - Jul 17, 2020 |
Virtual (EDT), |
| FDA Inspections - What Regulators Expect and How to Prepare |
Jul 20, 2020 - Jul 21, 2020 |
Virtual (EDT), |
| Writing Effective SOP and Other Process Documents |
Jul 20, 2020 - Jul 21, 2020 |
Virtual (CDT), |
| Biostatistics for Non-Statisticians |
Jul 21, 2020 - Jul 23, 2020 |
Virtual (EDT), |
| Qualifying, Management and Auditing of Contract Manufacturing Organizations |
Jul 27, 2020 - Jul 28, 2020 |
Virtual (EDT), |
| Quality Assurance/Quality Control for Biologics and Biopharmaceuticals |
Jul 29, 2020 - Jul 31, 2020 |
Virtual (EDT), |
| US Cosmetic Regulation: FDA CFR Title 21 Training |
Aug 03, 2020 - Aug 05, 2020 |
Virtual (EDT), |
| Specifications for APIs & Pharmaceutical Drug Products |
Aug 05, 2020 - Aug 06, 2020 |
Virtual (EDT), |
| Design Control for Medical Device Professionals |
Aug 10, 2020 - Aug 11, 2020 |
Virtual (CDT), |
| Design Validation, Verification, and Risk Analysis for Medical Device Professionals |
Aug 12, 2020 - Aug 13, 2020 |
Virtual (EDT), |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Aug 17, 2020 - Aug 18, 2020 |
Virtual (EDT), |
| Technical Writing for Pharma, Biotech and Med Devices |
Sep 09, 2020 - Sep 11, 2020 |
Virtual (EDT), |
| Preparing the CMC Section for NDAs/INDs/CTDs |
Sep 10, 2020 - Sep 11, 2020 |
Virtual (EDT), |
| Effective Document Management for Pharma, Biotech & Medical Device |
Sep 14, 2020 - Sep 15, 2020 |
Virtual (EDT), |
| Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products |
Sep 14, 2020 - Sep 15, 2020 |
Virtual (EDT), |
| Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management |
Sep 14, 2020 - Sep 15, 2020 |
Virtual (EDT), |
| CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars |
Sep 15, 2020 - Sep 17, 2020 |
Virtual (EDT), |
| Clinical Trial Project Management, Phase 1-4 Best Practices |
Sep 16, 2020 - Sep 18, 2020 |
Virtual (EDT), |
| Preparation of FDA Submissions and Communicating with the FDA |
Sep 17, 2020 - Sep 18, 2020 |
Virtual (EDT), |
| CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars |
Sep 21, 2020 - Sep 23, 2020 |
Virtual (BST), |
| Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems |
Sep 21, 2020 - Sep 22, 2020 |
Virtual (EDT), |
| Auditing and Qualifying Suppliers and Vendors |
Sep 24, 2020 - Sep 25, 2020 |
Virtual (BST), |
