Services

Data Integrity Training Build Competency in Maintaining Compliance Across Computerized & Paper-Based Systems Computerized systems are widely used in pharmaceutical and biopharmaceutical environments to capture, analyze, store, and report data, and to control equipment and processes. Internal and external audits have consistently revealed gaps in validated computer controls and Data…

Computerized System Validation (CSV) Strengthen Compliance by Validating Every System — from Software to Shop-Floor Automation Target Audience QA / QC IT and Automation Teams Production and Shop-Floor Operations Validation Teams Engineering Teams Project & System Implementation Teams Data Management and Documentation Staff 2-Computerized System Validation Course Outline Day One…

Quality Metrics Training Measure What Matters. Improve What Counts. The FDA has shifted from routine biannual inspections to a risk-based inspection model under the Food and Drug Administration Safety and Innovation Act (FDASIA). Quality Metrics now play a vital role in demonstrating the strength of a pharmaceutical manufacturer’s quality system.This…

Advanced Good Manufacturing Practices Introduction to Good Manufacturing Practices (cGMP) Build a Strong GMP Foundation for Daily Operations and Regulatory Confidence This course presents the principles and fundamental requirements of Good Manufacturing Practices (GMP) and helps participants understand their role within the quality system so they can practice GMP reliably…

HVAC Qualification & Validation for GMP Facilities Master Compliance for Sterile and Non-Sterile Facility HVAC Systems This training provides a complete understanding of HVAC qualification and validation requirements in pharmaceutical and life-science facilities, covering both sterile and non-sterile environments. The course teaches how to evaluate, design, qualify, validate, operate, and…

Statistical Analysis in pharmaceutical industry Statistics in Pharmaceutical Science: Principles and ApplicationsMaster Statistical Tools to Strengthen Decision-Making, Quality, and Process Performance This training is designed for pharmaceutical professionals with minimal or no previous exposure to statistics. It provides a strong understanding of statistical concepts and equips participants to apply statistical…

How to inspection cGMP Compliance Inspection Master Inspection Readiness and Audit Execution with Confidence This course provides a practical understanding of cGMP auditing from both perspectives — preparing for inspections and conducting inspections. It addresses the regulatory expectations of EU and US agencies and equips participants with the skills to…

Analytical Method Validation Validate Methods with Confidence — From Definitions to Execution, Reporting, and Transfer Analytical Method Validation is essential to demonstrate that analytical procedures are suitable for their intended purpose. It is a mandatory requirement for marketing authorization and a core element of GMP compliance. This training provides participants…

Production and Packaging Troubleshooting Solve Manufacturing & Packaging Problems with Practical, Real-World Techniques This training provides hands-on troubleshooting skills for pharmaceutical production and packaging operations. Participants learn how to identify, analyze, and eliminate recurring defects across solid, semi-solid, liquid, suspension, and sterile dosage forms. The program also addresses optimization of…

Water Purification Water Purification, Storage & Distribution System Qualification and Validation Master Design, Compliance and Validation of Pharmaceutical Water Systems This course covers the design, qualification, operation, and validation of pharmaceutical water systems, including Purified Water (PW), Water for Injection (WFI), Pure Steam, and their distribution systems. Participants gain complete…

Cleaning Validation Achieve Robust Cleaning Programs That Meet Regulatory and Inspection Expectations Cleaning validation continues to be one of the highest-scrutiny compliance areas in pharmaceutical inspections. From 2000 to 2010, around 25% of FDA Warning Letters cited concerns related to cleaning and cleaning validation. Today, the control of cleaning processes…

Preparing for an FDA & EU Audit Inspection Readiness Starts With Knowledge, Strategy and Confident Execution Auditing is a critical function within pharmaceutical manufacturing because it provides management with insight into how effectively the quality system protects product and patient safety. A GMP-licensed manufacturer must always be audit-ready — not…