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GMP Courses Offered

Basic Course

  • Writing Good and Effective Procedures
  • Writing It Down! Keeping Good Records Part 1
  • Writing It Down! Keeping Good Records Part 2
  • Keeping Things Clean – Guarding Against Contamination
  • People! The Key to GMP Compliance
  • Following Our Procedures for Consistency
  • Managing Our Materials to Prevent Contamination, Mix-ups, and Errors
  • Keeping Our Buildings and Equipment in Good Shape
  • Being Sure – Checking and Double Checking
  • How Am I Doing? Performing Self Audits
  • Our Customers are Called Patients and They Trust Us

 

ADVANCED GMP COURSE – LEVEL 1

  • The How-to Guide to Effective Cleaning and Cleaning Validation
  • Validation Protocol Execution and Addressing Deviations
  • Fundamentals of Quality by Design (QbD)
  • New Revisions to Drug cGMP: What You Must Do to Comply
  • Effective Microbial Control in Pharmaceutical Manufacturing Operations: Preventing Contamination of Drug Products
  • Effectively Implementing CAPA (Corrective and Preventive Action): A Risk Mitigating Quality System
  • Implementing a Risk-based Approach to GMP Compliance
  • An FDA Requirement for New or Modified Facilities or Systems
  • Validation of Water Systems in the Biopharmaceutical Industry
  • Using Statistical Methods to Design Method Validation
  • Validation Protocol Development and Acceptance Criteria
  • Validation and Change Control: The Validation Life Cycle
  • Validation of Heating, Ventilation, and Air Conditioning Systems in the Biopharmaceutical Industry
  • Environmental Monitoring: Getting it Right!
  • Master Planning for Validation: Complying with FDA’s New Guidance

 

ADVANCED GMP COURSE – LEVEL 2

  • Developing and Deploying a Successful GMP Training System
  • Implementing FDA’s New Guidance: Quality Systems Approach to Pharmaceutical CGMP Regulations
  • Implementing cGMPs for Dietary Supplements
  • A Case Study in Commissioning and Validation: Application of Commissioning and Validation to a cGMP Project
  • How to Implement FDA’s NEW Guidance on Process Validation 
  • FDA Inspections: What to Expect
  • FDA Inspections: How to Prepare
  • How to Conduct a Successful Supplier Audit: Protecting Your Supply Chain
  • Application of Design of Experiments (DOE) to Process Characterization
  • How to Manage Regulatory Inspections: Getting Ready: Pre-Inspection Auditing, Pre-Approval Inspection Preparation, and System-based Inspections
  • How to Manage the Inspection Room and the Control (War) Room during Regulatory Inspections
  • Staff Training and Preparation for a Regulatory Inspection
  • Developing an Effective Response to Regulatory Inspections (FDA and EU)
  • Effective GMP Auditing: Skills to Audit Manufacturing, 
  • Proven Steps in Reducing Waste in Process Validation
  • Optimizing Key Elements of an Effective Compliance Program
  • How Far is Too Far? Using Statistical Methods for Effective Outlier Detection 
  • How to Effectively Manage Out of Specification (OOS) Results for Pharmaceutical Manufacturers
  • Laboratory Investigations
  • Practical and Effective Application of Design Review:
  • Defining Risk and Risk Levels
  • Engineering Quality by Design (QbD)
  • Effective Data Presentation and Outlier Analysis
  • How to Investigate Deviations and Failures Effectively.