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Since 2001 CfPIE has
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- AMDE, PK/TK & Drug Metabolism in Drug Discovery and Development
- Advanced Topics in Biostatistics for Non-Statisticians
- Analytical Chemistry Principles for Pharmaceutical Scientists
- Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
- Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
- Auditing and Qualifying Suppliers and Vendors
- Best Practices for an Effective Cleaning Validation Program
- Biostatistics for Non-Statisticians
- CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines
- CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars
- Change Control - GMP Requirements and FDA Enforcement
- Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management
- Clinical Document Management: A Trial-by-Trial Compliance Approach
- Clinical Trial Project Management, Phase 1-4 Best Practices
- Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
- Computer System Validation
- CRO, CDMO and Non-Clinical Vendor Management Fundamentals
- Development and Validation of Bioanalytical Assays for Biologics: Quantification (PK) and Immunogenicity Assays
- Effective Document Management for Pharma, Biotech & Medical Device
- Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
- Ethics in Research - Values for Responsible Conduct of Research
- European Regulatory Procedures - EMA & National Requirements
- FDA Inspections - What Regulators Expect and How to Prepare
- GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials
- GMP Training for the QC Laboratory
- Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements
- Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
- Good Manufacturing Practices Training | GMP Course
- Human Error Prevention (HEP) - Risk Factors and Strategies
- Implementing and FDA Compliant Stability Program
- Integration of Risk Management Principles and Activities into the Pharmaceutical Quality System
- Intro to Medical Device Submission - 510(s)s, PMAs & Exemptions
- Introduction to Medical Combination Products
- Introduction to Statistical Analysis of Laboratory Data
- Introduction to Vaccines - CMC Regulatory and Quality Aspects
- Laboratory Equipment Validation and Qualification
- Lyophilization Technology - Application of Scientific Principles
- Marketing & Advertising of Pharmaceutical & Medical Devices
- Medical Device Process Validation Training for Professionals
- Medical Devices: Developing Effective Post Market Surveillance and Compliant Handling Systems
- Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries
- OTC Drug and Personal Care Product GMP & FDA Regulation
- Oncology Drug Development Course - A Comprehensive Overview
- Overview of FDA Regulatory Compliance for Medical Devices
- Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals
- Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy
- Preparation of FDA Submissions and Communicating with the FDA
- Preparing the CMC Section for NDAs/INDs/CTDs
- Process Validation for Drugs and Biologics
- QbD - Product & Process Optimization using Design of Experiments
- Quality Assurance/Quality Control for Biologics and Biopharmaceuticals
- RNA Biotechnology - An Introductory Course
- Specifications for APIs & Pharmaceutical Drug Products
- Technical Writing for Pharma, Biotech and Med Devices
- The Drug Development Process from Concept to Market
- US Medical Device & Quality Systems Regulations - Design Controls & Validation
- Writing Effective SOP and Other Process Documents
ABOUT US
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site, and certification programs.
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All Rights Reserved | CfPIE Inc. | Our courses and materials are copyrighted by CfPIE, Inc. and may not be used or reproduced without the written permission of CfPIE, Inc. management. | In partnership with CCC