Clinical and Non-Clinical Training Courses from CfPA

Browse the Clinical/Non-Clinical courses below or visit our GCP Training or GLP Training pages.

Course Title	Scheduled
21 CFR Part 11: Strategies for Cost Effective Compliance Using a Risk-based Approach
ADME Fundamentals
Auditing and Inspecting Clinical Research in the Global Environment
Auditing and Inspecting Preclinical Research for GLP Compliance
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)
Biosafety of Biological Drug Products
Biostatistics for the Non-Statistician - Beyond the Basics
Characterization of Proteins: Isolation & Analysis
Claim Substantiation for Clinical Studies of Cosmetic Products
Clinical Testing Submissions
Combination Product Development: Safety/Registration/Approval
Computerized Systems Used in Clinical Investigations: the New FDA Guidance
Conducting Effective Quality Audits
Crackdown on Institutional Review Boards (IRBs)
Developing Specifications for Drug Substances (APIs) and Drug Products
Early Stage Clinical Studies for Drugs and Devices
Effective Clinical Data Acceptance Testing
Effective Tools in Selecting a CRO
Effectively Managing CROs
Effects of Psychological Factors and Stress on Skin Inflammatory Disorders
Endotoxin Testing: Resolving Interference and Test Validation
FDA Quarterly Briefing–January 2009
FDA Quarterly Briefing–July 2008
FDA Quarterly Briefing–July 2009
FDA Quarterly Briefing–October 2008
FDA Quarterly Briefing–October 2009
Fundamentals of Biochemistry: Background for Biotechnology
GLP Study Director
Good Clinical Practices (GCP)
Good Laboratory Practices (GLP)
Guidelines for Skin Absorption Studies
Guidelines to In Vitro Skin Absorption Studies
INDs/NDAs/CTDs
Introduction to Drug Delivery Technology
IQ, OQ, PQ
Lyophilization: Optimized Pre-Formulation, Formulation, and Cycle Development Techniques
Measurement Uncertainty in Analytical Chemistry
Meeting Today’s FDA Requirements for Clinical Trial Processes
Monitoring of Clinical Drug Studies
Non-Clinical Drug Safety Evaluation and Drug Development
Orphan Drug Application and Submission
Overcoming the Challenges to Transdermal Drug Delivery Development–An Introduction
Practical Biostatistics for the Non-Statistician - The Basics
Preparation, Packaging and Labeling of Clinical Trial Materials
Principles of Contemporary Immunology
Qualification and Validation of Analytical Methods for Protein Products
Safety Assessment of Cosmetic Ingredients and Formulations–An Introduction
Selecting and Managing CROs
Testing for Acute Chemical Toxicity – In Vitro Approaches Compliance with REACH and the 7th Amendment
Testing for Cytotoxicity-Compliance with REACH and the 7th Amendment
Testing for Eye Irritation and Corrosion: Compliance with REACH and the 7th Amendment
Testing for Genotoxicity, Mutagenicity and Carcinogenicity: Compliance with REACH and the 7th Amendment
Testing for Toxicity to Reproduction and Endocrine Disruption – Compliance with REACH and the 7th Amendment
The China Syndrome: Quality Issues in Manufacturing
Toxicokinetics and Skin Metabolism Testing: Compliance with REACH and the 7th Amendment
Writing and Implementing Clinical Protocols