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Course Title
Scheduled
Analytical Methods Validation for FDA Compliance
Best Practices in Being “On-Call” for FDA Submission Audits
Best Practices in SAS Statistical Programming for Regulatory Submission
Best Practices in SAS Statistical Programming for Regulatory Submission: Creating Publication-Quality Summary Tables (SECOND in a Two-Part Series)
Best Practices in SAS Statistical Programming for Regulatory Submission: Understanding and Applying the QC Plan to Validate Summary Tables (FIRST in a Two-Part Series)
Biosafety of Biological Drug Products
Calibration in the FDA Regulated Industry
Choosing Sensors, Monitors and Instruments for PAT Programs
Compare and Conquer SAS Programming Techniques for FDA Submissions
Designing the "State of the Art" Laboratory
High Performance Liquid Chromatography I: Fundamentals, Equipment, and Operation
History, Theory, and Instrumentation of Near-Infrared Spectroscopy
Instrumental Methods for Pharmaceutical Trace Metals Analysis
IQ, OQ, PQ
Keys to Risk Management: Implementation, Documentation, Monitoring and Mitigation
Near Infrared Spectroscopy
PAT Online Process Analysis
Pharmaceutical Laboratory Information Management System (LIMS)
Pharmacokinetics—ADME Fundamentals
Practical Problem Solving in Chemical Analysis
Proven Methods to Root Cause Analysis for CAPA
Qualification and Validation of Analytical Methods for Protein Products
Qualification/Validation for Bacterial Endotoxin Testing (BET)
Quality Assurance for the Analytical Laboratory
Real World Approaches to PAT and QbD Implementation
Role of Pharmaceutical QA/QC in Quality Systems
Statistical Analysis of Laboratory Data
Statistical Process Control for PAT
Strategies for Leveraging PAT/QbD in Biologic Applications
USP Guidelines for Product Quality and Product Performance Tests
Validation and Certification of the Pharmaceutical Quality Control Laboratory