Training and education for the pharma & biotech industry, since 1990.
PCS has 33 of experience in providing training to GMP and GDP regulated organizations. This includes manufacturers, distributors, laboratories, hospitals, pharmacies and related industries. An advantage of our in-house training courses is that the program, training content, workshops, exercises and methodology can be adapted to suit the specific needs of your company.
- Good Manufacturing Practices (GMP Basics & Expert)
- Good Distribution Practices (GDP Basics & Expert)
- Data Integrity
- Human Error Reduction
- Auditing & Self Inspections
- Risk Management
- Train the Trainer
Below you will find an overview of some of our internal training courses. The list below is not all-encompassing. Contact PCS if the training you are looking for is not listed.
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Internal & External Auditing
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Advanced Auditing Techniques
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FDA Inspection Preparedness
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Auditing QC Laboratories
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Auditing Aseptic Laboratories
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Auditing API / Excipient Suppliers
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Auditing Computerised Systems
The production process is the most important element within every pharmaceutical company. To retain control of this process is essential to adhering to GMP & GDP regulations. These PCS courses are designed to assist your company in controlling, upgrading and assessing your production processes.
Auditing (Inspection) of suppliers is a GMP & GDP requirement. PCS has a number of auditing courses which can be provided in-house. PCS can focus on your specific GMP & GDP Auditing procedures and/or policies.
As we are working in a high-risk industry it is essential for engineering activities to be executed according to GMP & GDP regulations. PCS can help your Maintenance and Engineering departments develop a better understanding of these regulations and adapt accordingly.
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GEP (Good Engineering Practices)
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Equipment Management
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Water Systems
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Self-Inspection Techniques
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Equipment Maintenance
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Equipment Calibration
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Equipment Validation
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Validation Master Plan
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Sterilisation Process
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Sterilisation and Validation – Advanced
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Bio-Indicators
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Implementation of ASTM2500 (Risk-Based Qualification)
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Equipment Control during the Life Cycle
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Packaging
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Aseptic Production
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Environmental Monitoring
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Disinfection and Sterilisation
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Process Validation
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Risk Analysis of Production Processes
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Hygiene for Production Personnel
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Microbiology for Non-Microbiologists
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Cleaning Validation
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HACCP
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FMEA
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Principles of Contamination Control
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Critical to Quality Parameters (CQP)
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Critical to Quality Attributes (CQA)
Quality Management systems are difficult to implement, maintain or upgrade. PCS has a number of courses aimed at specific parts of a QMS which can be adapted to focus on your own Quality System.
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Documentation / System Management
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Setting up a CAPA System
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Deviation / CAPA Management
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Change Control
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Risk Management
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Third Party Contracting
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Contract Production
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Contract Analysis
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Training Systems
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Train the Trainer
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Supplier Qualification
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PQR (Product Quality Review
The Quality Control department is responsible for testing a variety of parameters. Whether its a complex finished product or a bag of talc, you want the tests to be accurate and according to GMP & GDP regulations. PCS can help your QC department reduce deviations and apply to regulatory requirements through its courses specifically designed for the Quality Control laboratory.
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GcLP (Good Control Laboratory Practices)
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Laboratory Equipment Management
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OOS (Out of Specification)
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Reagents and Standards
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Validation of Analytical Methods
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Validation of Microbiological Methods
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Stability Testing
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Transfer of Analytical Methods
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Handling RAW Data
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Implementation of LIMS
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Spread Sheet Validation
The following courses do not apply to a specific category but are designed to offer participants different levels of GMP & GDP related training. Process operators might benefit from a GMP Basic Course while upper management may benefit from a Quality Culture training or GMP Update seminar.
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GMP – the Basics
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GMP for Process Operators
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GMP for Mid-Level Management
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GMP for Upper Management
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GMP Awareness
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Quality Culture
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Annual GMP Update 2023
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Good Distribution Practices (GMP)
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GMP for Biotechnological Products
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GMP – For the Entire Organization
