Our training courses, seminars and workshops are aimed at professionals from the areas of Production, Engineering and Maintenance, Physicochemical and Microbiological Laboratory, Technical Services (Validation and Qualification) and Quality that collaborate in industries with an interest in implementing these systems in their domain areas in a focused, proficient and dynamic way building from the base of their already applied knowledge that our experience offers them.
In all of our courses we offer follow-ups with advice in your real cases to carry through the knowledge and developed skills.
We have experts with 20+ years in the industry, with certifications from different recognized organizations including certification as instructors and course designers by CONOCER* (National Council for Standardization and Certification of Labor Competencies) that endorse our services.
DATE TBD
Course 1
QUALIFICATION TOOL KIT
QUALIFICATION TOOL KIT
Course duration: 40 hours (7 weeks)
SYLLABUS
Module 1: Qualification Basics and Documentation
Module 2: User Requirement Specification vs Functional Specification Module 3: Risk Analysis and Design of Experiments
Module 4: Qualification of Productive, Manual and Automatic Equipment Module 5: Critical Systems (HVAC, PW, CA, SG)
Module 6: Laboratory Equipment
Module 7: Autoclaves / Cold Chambers
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DATE TBD
Course 2
ANALYTICAL METHODS DEVELOPMENT, QBD
ANALYTICAL METHODS
Course duration: 30 hours (6 weeks)
SYLLABUS
Module 1: Good Laboratory Practices
Module 2: Data Integrity in the Laboratory
Module 3: Introduction to Analytical Method Development
Module 4: Risk Analysis
Module 5: Design of Experiments
Module 6: Validation and Transfer of Analytical Methods
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DATE TBD
Course 3
PROJECT MANAGEMENT
PROJECT MANAGEMENT
Course duration: 30 hours (5 weeks)
SYLLABUS
Module 1: Introduction to Validation Oriented Project Management
Module 2: Project Integration Management
Module 3: Project Scope Management
Module 4: Project Schedule Management
Module 5: Project Quality Management
Module 6: Project Resource Management
Module 7: Risk Analysis in Project Management
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DATE TBD
Course 4
VALIDATION TOOL KIT
VALIDATION TOOL KIT
Course duration: 35 hours (7 weeks)
SYLLABUS
Module 1: Validation Elementals
Module 2: Stage 1: Process Design
Module 3: Stage 1: Risk Analysis and Determination of Critical Parameters
Module 4: Stage 1: Design Of Experiments / Engineering Batches
Module 5: Stage 1: Process Transfer
Module 6: Stage 2: Performance Qualification (Validation)
Module 7: Statistical Evaluation
Module 8: Phase 3: Continuous Monitoring Of Processes (Bases and Documentation)
Module 9: Phase 3: Statistical Process Analysis
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DATE TBD
Course 5
CSV
CSV
Course duration: 14.5 hours (3 weeks)
SYLLABUS
Module 1: Basics
Module 2: Spreadsheets
Module 3: Computerized Systems
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DATE TBD
Course 6
MANUFACTURING OF INJECTABLES
MANUFACTURING OF INJECTABLES
Course duration: 36 hours (6 weeks)
SYLLABUS
Module 1: Critical Systems
Module 2: Qualification of Areas, Systems and Equipment for the Production of Injectables
Module 3: Validation of Processes for the Production of Injectables
Module 4: GMP’s
Module 5: Microbiological Control for Injectables
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DATE TBD
Course 7
CLEANING VALIDATION
CLEANING VALIDATION
Course duration: 38 hours (7 weeks)
SYLLABUS
Module 1: Basic Concepts
Module 2: Design of Cleaning Procedures
Module 3: Risk Analysis to Determine the Worst-Case Scenario
Module 4: Limit Calculation
Module 5: Recovery Qualification
Module 6: Visual Inspection Qualification
Module 7: Developing Analytical Methods for Cleaning
Module 8: Validation of Analytical Methods for Cleaning
Module 9: Microbiology for Cleaning
Module 10: Sustaining of Validated State