| Course Title |
Course Date |
Location |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Mar 04, 2021 - Mar 05, 2021 |
Virtual (CST) |
| FDA Inspections - What Regulators Expect and How to Prepare |
Mar 04, 2021 - Mar 05, 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) |
| Preparing the CMC Section for NDAs/INDs/CTDs |
Mar 11, 2021 - Mar 12, 2021 |
Virtual (CST) |
| 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) |
| Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems |
Apr 08, 2021 - Apr 09, 2021 |
Virtual (CDT) |
| Biostatistics for Non-Statisticians |
Apr 12, 2021 - Apr 14, 2021 |
Virtual (CDT) |
| Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries |
Apr 12, 2021 - Apr 13, 2021 |
Virtual (CDT) |
| Selecting and Managing CROs |
Apr 22, 2021 - Apr 23, 2021 |
Virtual (CDT) |
| Integration of Risk Management Principles and Activities into the Quality System |
Apr 22, 2021 - Apr 23, 2021 |
Virtual (CDT) |
| Overview of FDA Regulatory Compliance for Medical Devices |
Apr 26, 2021 - Apr 27, 2021 |
Virtual (CDT) |
| Auditing and Qualifying Suppliers and Vendors |
Apr 26, 2021 - Apr 27, 2021 |
Virtual (CDT) |
| Lyophilization Technology-Application of Scientific Principles |
Apr 28, 2021 - Apr 29, 2021 |
Virtual (CDT) |
| Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy |
May 03, 2021 - May 05, 2021 |
Virtual (CDT) |
| Technical Writing for Pharma, Biotech and Med Devices |
May 05, 2021 - May 07, 2021 |
Virtual (CDT) |
| CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars |
May 05, 2021 - May 07, 2021 |
Virtual (CDT) |
| Introduction to Medical Combination Products |
May 10, 2021 - May 12, 2021 |
Virtual (CDT) |
| US Cosmetic Regulation: FDA CFR Title 21 Training |
May 12, 2021 - May 14, 2021 |
Virtual (CDT) |
| Product Quality Reviews |
May 13, 2021 - May 14, 2021 |
Virtual (CDT) |
| Pharmaceutical Production Batch Record Review | Training |
May 17, 2021 - May 18, 2021 |
Virtual (CDT) |
| Quality Assurance/Quality Control for Biologics and Biopharmaceuticals |
May 17, 2021 - May 19, 2021 |
Virtual (CDT) |
| Design Control for Medical Device Professionals |
May 20, 2021 - May 21, 2021 |
Virtual (CDT) |
| Design Validation, Verification, and Risk Analysis for Medical Device Professionals |
May 24, 2021 - May 25, 2021 |
Virtual (CDT) |
| Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions |
May 24, 2021 - May 25, 2021 |
Virtual (CDT) |
| Process Validation for Drugs and Biologics |
Jun 07, 2021 - Jun 08, 2021 |
Virtual (CDT) |
| European Regulatory Procedures - EMA & National Requirements |
Jun 10, 2021 - Jun 11, 2021 |
Virtual (EDT) |
| Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products |
Jun 10, 2021 - Jun 11, 2021 |
Virtual (CDT) |
| Best Practices for an Effective Cleaning Validation Program |
Jun 14, 2021 - Jun 15, 2021 |
Virtual (CDT) |
| Developability Assessment – The Logical Approach to Discovery Lead Selection |
Jun 14, 2021 - Jun 15, 2021 |
Virtual (CDT) |
| Laboratory Equipment Validation and Qualification |
Jun 14, 2021 - Jun 15, 2021 |
Virtual (CDT) |
| Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies |
Jun 16, 2021 - Jun 18, 2021 |
Virtual (CDT) |
| Stability Programs for Determining Product Shelf Life |
Jun 17, 2021 - Jun 18, 2021 |
Virtual (CDT) |
| CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines |
Jun 17, 2021 - Jun 18, 2021 |
Virtual (CDT) |
| Marketing & Advertising of Pharmaceutical & Medical Devices |
Jun 22, 2021 - Jun 23, 2021 |
Virtual (CDT) |
| ADME, PK/TK & Drug Metabolism in Drug Discovery and Development |
Jun 23, 2021 - Jun 24, 2021 |
Virtual (CDT) |
| Basic GMP Training for the QC Laboratory |
Jun 28, 2021 - Jun 29, 2021 |
Virtual (CDT) |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Jul 12, 2021 - Jul 13, 2021 |
Virtual (CDT) |
| FDA Inspections - What Regulators Expect and How to Prepare |
Jul 15, 2021 - Jul 16, 2021 |
Virtual (CDT) |
| Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products |
Jul 19, 2021 - Jul 20, 2021 |
Virtual (CDT) |
| Good Manufacturing Practices Training | GMP Course |
Jul 21, 2021 - Jul 23, 2021 |
Virtual (CDT) |
| Writing Effective SOP and Other Process Documents |
Jul 26, 2021 - Jul 27, 2021 |
Virtual (CDT) |
| Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements |
Jul 26, 2021 - Jul 28, 2021 |
Virtual (CDT) |
| Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries |
Sep 22, 2021 - Sep 24, 2021 |
Virtual (CDT) |
| GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials |
Sep 23, 2021 - Sep 24, 2021 |
Virtual (CDT) |
| Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements |
Nov 03, 2021 - Nov 05, 2021 |
Virtual (CST) |
| Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies |
Dec 08, 2021 - Dec 10, 2021 |
Virtual (CST) |
| Understanding & Implementing New EU Clinical Trial Regulation & GDPR |
Dec 09, 2021 - Dec 10, 2021 |
Virtual (CDT) |
