Courses

Education Course | Curriculum

Entering the U.S. Market: What Does it Take? (On-Demand)

GMP-PHARM-15

Education Course | Curriculum

Pharmacopeial Forum (PF) Alert 51(3) (On-Demand)

PF-51-3

Education Course | Curriculum

Raw Materials Quality: Requirements, Limitations, and Recommendations (from an Ancillary Material Manufacturer’s Perspective) (On-Demand)

BIO-RAW-15

Education Course | Curriculum

Validation, Verification, and Transfer of Analytical Procedures (On-Demand)

CM-1225-02

Education Course | Curriculum

EU Annex 1 in Full Effect Are Manufacturers with EU Drug Products Prepared (On-Demand)

GMP-PHARM-17

Education Course | Curriculum

Best Practices for Mass Spectrometry-Based Multi-Attribute Method (MAM) for Therapeutic Proteins USP General Chapter 1060 (On-Demand)

BIO-MAM-02

Education Course | Curriculum

USP Certificate on Impurities (On-Demand)

CM-CERT-06

Education Course | Curriculum

An Attribute Focused Approach to Identify and Control Raw Material Variability (On-Demand)

BIO-RAW-10

Education Course | Curriculum

Analytical Strategies for Characterization of Stereopure Platform Chemistry (On-Demand)

BIO-PEP-25

Education Course | Curriculum

eLearning: Foundations of GMP: Active Pharmaceutical Ingredient (API)

GMP-EL-02

Education Course | Curriculum

What’s New in Biologics? Focus on USP’s Vaccine Initiatives (On-Demand)

BIO-NEW-03

Education Course | Curriculum

eLearning: Foundations of GMP: Validation

GMP-EL-05

Education Course | Curriculum

What You Always Wanted to Know About USP Reference Standards (On-Demand)

EURS-07

Education Course | Curriculum

USP Excipients Workshop: Improved Excipient Characterization Beyond USP Monographs (On-Demand)

EXC-WS-06

Education Course | Curriculum

LC-HRMS-based Multi-attribute Method for Oligonucleotides (MAMO): Characterization and Impurity Profiling (On-Demand)

BIO-PEP-42

Education Course | Curriculum

USP General Chapter 797 Pharmaceutical Compounding—Sterile Preparations (On-Demand)

HQS-797-01

Education Course | Curriculum

eLearning: Foundations of GMP: Deviations, Root Cause Analysis (RCA) Tools and Corrective and Preventive Action (CAPA) - Sequence flow for handling of any non-conformance in the GMP environment

GMP-EL-04

Education Course | Curriculum

Analytical Method Development for Critical Impurities in Phosphoramidites (On-Demand)

BIO-PEP-24

Education Course | Curriculum

CMC Regulatory Considerations for Oligonucleotides and Peptides: Similarities and Differences (On-Demand)

BIO-PEP-17

Education Course | Curriculum

Development and Characterization of Monoclonal Antibody Therapeutics (On-Demand)

BIO-MAB-01

Education Course | Curriculum

PCM – Continuous Manufacturing: Presenting Your Business Case (On-Demand)

GMP-PHARM-19

Education Course | Curriculum

Quality Considerations for Plasmid DNA as a Starting Material for Cell and Gene Therapies (On-Demand)

BIO-PDNA-01

Education Course | Curriculum

Current Good Manufacturing Practices (cGMPs) for Dietary Supplements, 21 CFR Part 111 (On-Demand)

DS-GMP-01

Education Course | Curriculum

USPID Workflow Animation (On-Demand)

DIG-USPID-02

Education Course | Curriculum

USP 1469 Nitrosamines Impurities On-Demand Video Tutorials

CM-1469-01a