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FasTrainCourses

Dedicated to Safer and Faster Biopharmaceutical Product Development

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FasTrainCourses

Dedicated to Safer and Faster Biopharmaceutical Product Development

Live Webinar & Recordings Quote

Please fill out the form below entirely to receive a quote for live webinar enrollment or recordings of past webinars.

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Which training course are you interested in?*
- Potency Bioassay Training
- SPC for the Biopharmaceutical Industry
- Comparability: Statistical Fundamentals
- CMC & Its Roles in Drug Development
- Cell Culture and Cell Based Assays
- Tools for Quality Control
- Statistics for Bioassay
- Statistical Method for Bioassay
- Host Cell Proteins
- Annual GXP Update
- Annual GXP Training
- Basic GMPs for Early-Stage Product Development
- Basic Good Tissue Practices (GTP) Training
SPC for the Biopharmaceutical Industry Course options*
Please select your SPC for the Biopharmaceutical Industry sessions:*
- Session 1: Measurement
- Session 2: Relevant Concepts in Statistics
- Session 3: Control Charts
- Session 4: Lack of Control
- Session 5: Extremes of Control
- Session 6: Process Capability
- Session 7: Measurement Redux
- Session 8: Final Comments
Comparability: Statistical Fundamentals Course options*
Please select your Comparability: Statistical Fundamentals sessions:*
- Session 1: Introduction to Comparability
- Session 2: Comparability: Testing of Means
- Session 3: Defining the Margins
- Session 4: Comparability in 3-D
- Session 5: Introduction to Some Important Intervals
- Session 6: Comparability by Variability
- Session 7: Bringing it all Together/Summary
CMC & Its Roles in Drug Development Course options*
Please select your Entire CMC & Its Roles in Drug Development Course sessions:*
- Session 1: An Introduction to CMC
- Session 2: Manufacturing – The ‘M’ in CMC
- Session 3: Raw Materials
- Session 4: Drug Substance Process Development
- Session 5: Drug Product Process Development
- Session 6: cGMP Manufacturing
- Session 7: Operational Excellence & Risk Management
- Session 8: MFG Audit Readiness & Case Studies
Cell Culture and Cell Based Assays Course package options*
Please select your Cell Culture and Cell Based Assays sessions:*
- Session 1: Introduction into Mammalian Cell Culture
- Session 2: Maintenance of Cultured Cells
- Session 3: Contaminations in Cell Culture
- Session 4: Genetic Modifications
- Session 5: Cell Based Assays
Annual GXP Update Course package options*
Statistical Method for Bioassay Course package options*
Please select your Statistical Method for Bioassay sessions:*
- Session 1: Introduction to Bioassay (FREE!)
- Session 2: Statistical Fundamentals (1)
- Session 3: Statistical Fundamentals (2)
- Session 4: Intro to Bioassay Design
- Session 5: Intro to Bioassay Development
- Session 6: Setting Equivalence Bounds for Similarity Assessment
- Session 7: Mixed Models for Bioassay
- Session 8: Intro to DOE
- Session 9: Development & Robustness Experiments
- Session 10: Qualification & Validation Experiment Design & Analysis
- Session 11: Bioassay Stability Experiment Design & Analysis
- Session 12: Product Specification & Process Control Limits
- Session 13: Monitoring Bioassays
- Session 14: Questions, Discussion and Additional Resources
Potency Bioassay Training Course package options*
Please select your Potency Bioassay Training sessions:*
- Session 1: Introduction to Bioassays (FREE)
- Session 2: Relative Potency
- Session 3: Dose-Response Curves
- Session 4: Similarity Testing
- Session 5: Rare Reagents
- Session 6: QbD Tools for Development
- Session 7: The Use of Outlier Approaches in Bioassays
- Session 8: USP Recommendations
- Session 9: Qualification and Validation
- Session 10: Monitoring the Bioassay
- Session 11: The Reference Standard
- Session 12: Bioassay Inspections & Trends
Tools for Quality Control Course package options*
Please select your Tools for Quality Control sessions:*
- Session 1: Introduction to Tools for Quality Control (FREE!)
- Session 2: QC Laboratory Equipment
- Session 3: Analytical Rare Reagents
- Session 4: Basic Statistical Tools
- Session 5: Specifications and System Suitability Criteria
- Session 6: Statistical Process Control Charts
- Session 7: Specifications and the Use of Capability Analyses
- Session 8: Failure Investigations
- Session 9: Quality by Design (QbD)
- Session 10: Validating Methods
- Session 11: Transferring Methods
- Session 12: Recent Regulatory Audit Results
Statistics for Bioassay Course package options*
Please select your Statistics for Bioassay sessions:*
- Session 1: Statspeak – Statistical Terms & Why They Are Important (FREE!)
- Session 2: Descriptive Statistics
- Session 3: Statistical Plots
- Session 4: Hypothesis Testing
- Session 5: ANOVA (1 way & 2 way)
- Session 6: Linear Regression
- Session 7: The 4PL Model
- Session 8: Understanding the USP Guidance on System Suitability
- Session 9: Understanding the USP Guidance on Sample Suitability
- Session 10: Combining Results from Multiple Assays
- Session 11: Assay Validation
- Session 12: SPC - Monitoring Your Assay Over Time
Host Cell Proteins Course package options*
Please select your Host Cell Proteins sessions:*
- Session 1: Introduction to the Evolving Landscape of Host Cell Proteins (FREE!)
- Session 2: Generating High-Quality HCP Immunoassay Reagents
- Session 3: Characterization of Reagents for HCP Immunoassays
- Session 4: Development and Validation of an HCP Immunoassay
- Session 5: Use of Orthogonal Methods for HCP Characterization
- Session 6: HCP Control Strategy at All Development Phases
- Session 7: Overview of USP
- Session 8: Regulatory Expectations for HCP Analysis
- Session 9: Characterization of HCPs During Process Development
- Session 10: Clinical Case Studies
- Session 11: Future Trends
- Session 12: How to Assess Risk of HCPs in your Product
Basic GTP Training Course package options*
Please select your GTP Training sessions:*
- Session 1: Intro to the World of Drug Regulations
- Session 2: QSR vs. GMP vs. GTP
- Session 3: Good Tissue (cGTP) Requirements
Basic GMPs Course package options*
Please select your GMP sessions:*
- Session 1: Intro to the Product Development Cycle
- Session 2: The cGMPs
- Session 3: The cGMPs (continued)
- Session 4: Approaching Early Stage GMPs
- Session 5: Application Integrity Issues When Manufacturing Clinical Materials
- Session 6: Recent Pre-Approval Inspection Results
Annual GXP Training Course package options*
Please select your GXP Training sessions:*
- Session 1: GXPs and Their Legal Foundation
- Session 2: GMP 211 Continued
- Session 3: GLPs Part 58
- Session 4: Keeping the GXP Frame of Mind
- Session 5: When Things Go Astray
- Session 6: Tracking the Risk: Aseptic Processing
- Session 7: Hot Topics
- Session 8: Recent Inspection Trends and Case Studies
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Welcome to FasTrain Courses

FasTrain provides professional training for bio/pharmaceutical and biotech professionals. Our courses are designed to meet FDA, EMA and other regulatory agency training requirements.

Save time and precious travel dollars and still get the best up-to-date training in the industry. Our multi-session courses are designed to give you all the information you need to get your job done. Course Registration

Available Courses

Breaking Down CMC
Comparability: Statistical Fundamentals
Annual cGXP Update
Statistical Process Control for the Biopharmaceutical Industry
Cell Culture and Cell-Based Assays
Bioassay Training

Intro to Statistics for Bioassays
Statistical Method in Bioassay
Tools for Quality Control
Host Cell Protein
GXP Training
Basic Good Tissue Practices
Basic GMPs

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