| Course Title |
Course Date |
Location |
| Specifications for APIs & Pharmaceutical Drug Products |
Aug 05, 2020 - Aug 06, 2020 |
Virtual (EDT), |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Aug 17, 2020 - Aug 18, 2020 |
Virtual (EDT), |
| Good Manufacturing Practices Training | GMP Course |
Aug 24, 2020 - Aug 26, 2020 |
Virtual (PDT), |
| 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), |
| GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials |
Sep 14, 2020 - Sep 15, 2020 |
Virtual (PDT), |
| 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), |
| Lyophilization Technology-Application of Scientific Principles |
Sep 17, 2020 - Sep 18, 2020 |
Virtual (PDT), |
| CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars |
Sep 21, 2020 - Sep 23, 2020 |
Virtual (BST), |
| GMPs for OTC & Cosmetic Products - US and Global Requirements |
Sep 21, 2020 - Sep 22, 2020 |
Virtual (PDT), |
| Auditing and Qualifying Suppliers and Vendors |
Sep 24, 2020 - Sep 25, 2020 |
Virtual (BST), |
| Product Quality Reviews |
Oct 01, 2020 - Oct 02, 2020 |
Virtual (EDT), |
| Stability Programs for Determining Product Shelf Life |
Oct 01, 2020 - Oct 02, 2020 |
Virtual (EDT), |
| Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies |
Oct 05, 2020 - Oct 07, 2020 |
Virtual (EDT), |
| Biostatistics for Non-Statisticians |
Oct 07, 2020 - Oct 09, 2020 |
Virtual (EDT), |
| Auditing and Qualifying Suppliers and Vendors |
Oct 15, 2020 - Oct 16, 2020 |
Virtual (PDT), |
| Selecting and Managing CROs |
Oct 15, 2020 - Oct 16, 2020 |
Virtual (EDT), |
| Best Practices for an Effective Cleaning Validation Program |
Oct 15, 2020 - Oct 16, 2020 |
Virtual (PDT), |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Oct 19, 2020 - Oct 20, 2020 |
Virtual (BST), |
| Pharmaceutical Production Batch Record Review | Training |
Oct 19, 2020 - Oct 20, 2020 |
Virtual (PDT), |
| Integration of Risk Management Principles and Activities into the Quality System |
Oct 19, 2020 - Oct 20, 2020 |
Virtual (EDT), |
| Quality Assurance/Quality Control for Biologics and Biopharmaceuticals |
Oct 19, 2020 - Oct 21, 2020 |
Virtual (BST), |
| Process Validation for Drugs and Biologics |
Oct 19, 2020 - Oct 20, 2020 |
Virtual (PDT), |
| The Drug Development Process from Concept to Market |
Oct 20, 2020 - Oct 22, 2020 |
Virtual (EDT), |
| Basic GMP Training for the QC Laboratory |
Oct 21, 2020 - Oct 22, 2020 |
Virtual (PDT), |
| Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy |
Oct 21, 2020 - Oct 23, 2020 |
Virtual (PDT), |
| European Regulatory Procedures - EMA & National Requirements |
Oct 22, 2020 - Oct 23, 2020 |
Virtual (BST), |
| Developability Assessment – The Logical Approach to Discovery Lead Selection |
Oct 22, 2020 - Oct 23, 2020 |
Virtual (EDT), |
| Qualifying, Management and Auditing of Contract Manufacturing Organizations |
Oct 22, 2020 - Oct 23, 2020 |
Virtual (PDT), |
| Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries |
Oct 22, 2020 - Oct 23, 2020 |
Virtual (EDT), |
| ADME, PK/TK & Drug Metabolism in Drug Discovery and Development |
Oct 26, 2020 - Oct 28, 2020 |
Virtual (GMT), |
| The Drug Development Process from Concept to Market |
Oct 26, 2020 - Oct 28, 2020 |
Virtual (GMT), |
| QbD - Product & Process Optimization using Design of Experiments |
Nov 09, 2020 - Nov 11, 2020 |
Virtual (EST), |
| Computer System Validation |
Nov 09, 2020 - Nov 10, 2020 |
Virtual (EST), |
| FDA Inspections - What Regulators Expect and How to Prepare |
Nov 09, 2020 - Nov 10, 2020 |
Virtual (PST), |
| Technical Writing for Pharma, Biotech and Med Devices |
Nov 11, 2020 - Nov 13, 2020 |
Virtual (EST), |
| ADME, PK/TK & Drug Metabolism in Drug Discovery and Development |
Nov 16, 2020 - Nov 18, 2020 |
Virtual (EST), |
| Marketing & Advertising of Pharmaceutical & Medical Devices |
Nov 16, 2020 - Nov 17, 2020 |
Virtual (EST), |
| Preparing the CMC Section for MAAs-IMPDs |
Nov 16, 2020 - Nov 17, 2020 |
Virtual (GMT), |
| Good Manufacturing Practices Training | GMP Course |
Nov 16, 2020 - Nov 18, 2020 |
Virtual (EST), |
| Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products |
Nov 16, 2020 - Nov 17, 2020 |
Virtual (EST), |
| Introduction to Medical Combination Products |
Nov 18, 2020 - Nov 20, 2020 |
Virtual (EST), |
| Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products |
Nov 19, 2020 - Nov 20, 2020 |
Virtual (EST), |
| Development and Validation of Bioanalytical Assays for Biologics Quantitation and Immunogenicity Assays |
Dec 03, 2020 - Dec 04, 2020 |
Virtual (PST), |
| 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), |
