Available Courses

The following list identifies all the training courses presented by TRI in the past three years. Please see the current TRI calendar or contact us for details on these courses or to discuss your specific needs.

Aseptic Processing

  • Aseptic Processing Training Program (Lab)
  • Applying Lean to Aseptic Processes
  • CGMP Training for Sterile Manufacturing
  • Clean Room Design, Contamination Control and Environmental Monitoring for Controlled Environments
  • Cleanroom Management
  • Introduction to HACCP and Other Risk-Based Systems as Applied to Aseptic Pharmaceutical Manufacturing
  • Media Fills for Aseptic Processing
  • Quality Systems for Aseptic Processing (Lab)
  • Selection and Implementation of Advanced Aseptic Processing Techniques
  • Steam Sterilizers: Getting it Right from the Beginning
  • Sterile Pharmaceutical Dosage Forms: Basic Principles

Biotechnology

  • Achieving CGMP Compliance During Development of a Biotechnology Product
  • Application of Disposables in Biopharmaceutics (Lab)
  • Biopharmaceutical ICH Q10 for Senior Management
  • Bioprocess Validation
  • Biotechnology: Overview of Principles, Tools, Processes and Products
  • CGMP Biotechnology Facility Design and Validation
  • CGMP Manufacturing of Human Cell-Based Therapeutic Products
  • CMC Regulatory Compliance of Biopharmaceuticals
  • Downstream Processing (Lab)
  • Fermentation/Cell Culture Technologies Training Workshop (Lab)
  • Implementing CGMPs in Biopharmaceutical Manufacturing
  • Quality Control and Quality Assurance of Cell-Based Therapeutic Products
  • What Every Biotech Startup Needs to Know about CMC Compliance

Environmental Monitoring

  • Contamination Control (Lab)
  • Developing an Environmental Monitoring Program (Lab)
  • Environmental Monitoring
  • Environmental Control and Monitoring for Regulatory Compliance

Filtration

  • Filters and Filtration in the Biopharmaceutical Industry – Basics Course
  • Filters and Filtration in the Biopharmaceutical Industry – Advanced Course (Lab)

Microbiology

  • Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
  • Basic Microbiology for Aseptic Processing (Lab)
  • Choosing the "Right" Microbial Identification Program for your Biopharmaceutical/Pharmaceutical Quality Control Laboratory
  • Environmental Mycology Identification Workshop (Lab)
  • Fundamentals of Biopharmaceutical Microbiology
  • Fundamentals of D, F and z Value Analysis (Lab)
  • Investigating Microbiological Failures
  • Microbiological Issues in Non-Sterile Manufacturing
  • Microbiology of Water in a CGMP Environment
  • Mycoplasma in the Biotech and Pharmaceutical Industries
  • Pharmaceutical Water System Microbiology (Lab)
  • Rapid Microbiological Methods (Lab)
  • Rapid Microbiological Methods: Overview of Technologies, Validation Strategies, Regulatory Opportunities and Return on Investment
  • Use of HACCP for Microbiological Control in Pharmaceutical Manufacturing
  • Validation of Microbiological Test Methods

Quality/Regulatory Affairs

  • A Former FDA Investigator's Perspective on Conducting Effective Deviation Investigations, Root Cause Investigations, Corrective and Preventive Actions (CAPA)
  • A Risk Based Approach to Technology Transfer
  • Change Control: A Practical Workshop
  • CGMPs for Manufacturers of Sterile and/or Biotechnology Products
  • Documenting and Conducting OOS Investigations
  • Effective Application of a Quality Systems Approach to Pharmaceutical CGMPs in Compliance with the FDA Guidance
  • Effective Investigations and Corrective Actions
  • Elements of Risk Management
  • Essentials of US and EU GMPs for Manufacturers of Active Pharmaceutical Ingredients
  • Establishing and Operating an Effective GMP Auditing Program
  • FDA Inspection Readiness for a Training Systems Audit
  • Global Harmonized Drug GMPs – Closer Than You Think
  • GMP 101
  • GMPs for Manufacturers of Sterile and/or Biotechnology Products
  • GMP for Clinical Trial Materials: Regulations and Applications
  • Improving Sterile Drug Submissions to the FDA
  • Integration of Risk Management into Quality Systems
  • Making the Grade with the FDA
  • Managing Quality Systems
  • Practical and Effective Application of Design Review as a Risk Management Tool
  • Practical Applications of Risk Management
  • Preparing for an FDA Pre-Approval Inspection
  • Preparing for Regulatory Inspections for the FDA and EMA
  • Principles of Effective Quality Auditing
  • Quality and Compliance Management for Virtual Companies
  • Quality by Design for Biopharmaceuticals: Concepts and Implementation
  • Quality Programs – The Path to Continuous Improvement
  • Quality Risk Management
  • Risk Management for Aseptic Processing
  • Risk Mitigation Solutions: The Response to Risk Assessment
  • Role of the Quality Professional in the 21st Century
  • Root Cause Investigation for CAPA
  • The Quality System: Design, Implementation, Evaluation and Management of Processes
  • Writing Standard Operating Procedures

Training

  • Designing and Presenting Effective GXP Training Programs to Meet New FDA Training Requirements
  • FDA Inspection Readiness for a Training Systems Audit

Validation

  • Active Pharmaceutical Ingredients -  Manufacture and Validation
  • Basic Concepts in Cleaning and Cleaning Validation
  • Bioassay Development and Validation
  • Cleaning Validation (Lab)
  • Design of Experiments for Efficient and Practical Assay Development and Validation
  • Developing a Moist Heat Sterilization Program within FDA Requirements (Lab)
  • Development and Implementation of Qualification and Validation Programs – A Risk and Science Based Approach
  • DoE Basics for Validation by Design
  • Methods Validation
  • Process Validation and Product Lifecycle
  • Process Validation for Pharmaceuticals: Current and Future Trends with Emphasis on Implementation of the New FDA Guidance
  • Pharmaceutical Water Systems – Design and Validation
  • Qualification and Validation of API Manufacturing Operations
  • Six Sigma in Process Validation
  • Validating a Steam Sterilizer (Lab)
  • Validation of Microbiological Test Methods

Specialized

  • An Introduction to Visual Inspection (Lab)
  • Assessing Packaging and Processing Extractables/Leachables
  • Combination Products: Principles, Regulations, Current Issues and Solutions
  • Design Control
  • Developing a Robust Supplier Management Process
  • Developing and Validating a Cleaning and Disinfection Program for Controlled Environments
  • Development of Pre-filled Syringes (Lab)
  • Economical Design of Lyophilization Experiments Workshop
  • Fundamentals of Lyophilization
  • Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems
  • Quality and Regulatory Requirements and Development Strategy for Pre-filled Syringes, Pre-filled Drug Delivery Devices and Other Drug-Device Combination Products
  • Solving Strategic Quality, Regulatory and Technical Issues During the Development of Pre-filled Syringes, Autoinjectors and Injection Pens
  • Syringes and Elastomers: Understanding the Effects on Quality and Demonstrating the Production Process, Influences and Needs
  • Validation of Lyophilization

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