| Course Title |
Course Date |
Location |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Dec 03, 2020 - Dec 04, 2020 |
Virtual (PST), |
| European Regulatory Procedures - EMA & National Requirements |
Dec 03, 2020 - Dec 04, 2020 |
Virtual (EST), |
| Good Manufacturing Practices Training | GMP Course |
Dec 07, 2020 - Dec 09, 2020 |
Virtual (GMT), |
| The Drug Development Process from Concept to Market |
Dec 07, 2020 - Dec 09, 2020 |
Virtual (EST), |
| Preparing the CMC Section for NDAs/INDs/CTDs |
Dec 07, 2020 - Dec 08, 2020 |
Virtual (PST), |
| Understanding & Implementing New EU Clinical Trial Regulation & GDPR |
Dec 10, 2020 - Dec 11, 2020 |
Virtual (EST), |
| Quality Assurance/Quality Control for Biologics and Biopharmaceuticals |
Jan 11, 2021 - Jan 13, 2021 |
Virtual (CST), |
| Good Manufacturing Practices Training | GMP Course |
Jan 13, 2021 - Jan 15, 2021 |
Virtual (CST), |
| Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products |
Jan 21, 2021 - Jan 22, 2021 |
Virtual (CST), |
| Writing Effective SOP and Other Process Documents |
Jan 25, 2021 - Jan 26, 2021 |
Virtual (CST), |
| CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars |
Jan 25, 2021 - Jan 27, 2021 |
Virtual (CST), |
| Biostatistics for Non-Statisticians |
Jan 27, 2021 - Jan 29, 2021 |
Virtual (CST), |
| Auditing and Qualifying Suppliers and Vendors |
Jan 28, 2021 - Jan 29, 2021 |
Virtual (CST), |
| Process Validation for Drugs and Biologics |
Feb 01, 2021 - Feb 02, 2021 |
Virtual (CST), |
| Developability Assessment – The Logical Approach to Discovery Lead Selection |
Feb 04, 2021 - Feb 05, 2021 |
Virtual (CST), |
| Basic GMP Training for the QC Laboratory |
Feb 04, 2021 - Feb 05, 2021 |
Virtual (CST), |
| Stability Programs for Determining Product Shelf Life |
Feb 08, 2021 - Feb 09, 2021 |
Virtual (CST), |
| ADME, PK/TK & Drug Metabolism in Drug Discovery and Development |
Feb 10, 2021 - Feb 12, 2021 |
Virtual (CST), |
| Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions |
Feb 17, 2021 - Feb 19, 2021 |
Virtual (GMT), |
| Pharmaceutical Production Batch Record Review | Training |
Feb 18, 2021 - Feb 19, 2021 |
Virtual (CST), |
| Technical Writing for Pharma, Biotech and Med Devices |
Feb 22, 2021 - Feb 24, 2021 |
Virtual (CST), |
| Design Control for Medical Device Professionals |
Feb 22, 2021 - Feb 23, 2021 |
Virtual (CST), |
| Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy |
Feb 24, 2021 - Feb 26, 2021 |
Virtual (CST), |
| Best Practices for an Effective Cleaning Validation Program |
Feb 25, 2021 - Feb 26, 2021 |
Virtual (CST), |
| Design Validation, Verification, and Risk Analysis for Medical Device Professionals |
Feb 25, 2021 - Feb 26, 2021 |
Virtual (CST), |
| Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products |
Mar 01, 2021 - Mar 02, 2021 |
Virtual (CST), |
| Introduction to Medical Combination Products |
Mar 02, 2021 - Mar 05, 2021 |
Virtual (GMT), |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Mar 04, 2021 - Mar 05, 2021 |
Virtual, |
| FDA Inspections - What Regulators Expect and How to Prepare |
Mar 04, 2021 - Mar 05, 2021 |
Virtual (CST), |
| Laboratory Equipment Validation and Qualification |
Mar 08, 2021 - Mar 09, 2021 |
Virtual (CST), |
| GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials |
Mar 08, 2021 - Mar 09, 2021 |
Virtual (CST), |
| Computer System Validation |
Mar 08, 2021 - Mar 09, 2021 |
Virtual (CST), |
| The Drug Development Process from Concept to Market |
Mar 08, 2021 - Mar 10, 2021 |
Virtual (CST), |
| Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries |
Mar 10, 2021 - Mar 12, 2021 |
Virtual (CST), |
| Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management |
Mar 15, 2021 - Mar 16, 2021 |
Virtual (CDT), |
| Effective Document Management for Pharma, Biotech & Medical Device |
Mar 18, 2021 - Mar 19, 2021 |
Virtual (CDT), |
| GMPs for OTC & Cosmetic Products - US and Global Requirements |
Mar 18, 2021 - Mar 19, 2021 |
Virtual (CDT), |
| Preparation of FDA Submissions and Communicating with the FDA |
Mar 22, 2021 - Mar 23, 2021 |
Virtual (CDT), |
| Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products |
Mar 22, 2021 - Mar 23, 2021 |
Virtual (CDT), |
| Medical Device Process Validation Training for Professionals |
Mar 24, 2021 - Mar 26, 2021 |
Virtual (CDT), |
| Lyophilization Technology-Application of Scientific Principles |
Mar 25, 2021 - Mar 26, 2021 |
Virtual (CDT), |
