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GMP - In-House GMP Training by PCS

In-House GMP Training

For the Pharmaceutical Industry

If a larger number of employees should be trained, it can be financially advantageous to organise an in-house training. These can be held locally, so that as a rule, no additional travel or subsistence costs are incurred by the participants.

In-House GMP, GDP and GLP Training Solutions by PCS

Own Rules, Own Product, Own Requirements

An advantage of our internal training courses is that the program, training content, workshops, exercises and methodology can be adapted to suit the specific needs of your company. Made-to-measure training can be provided by incorporating your product and your procedures into the programme, so that the participants receive specific input that relates directly to their own tasks, responsibilities and daily experience.

Professional Trainers

PCS provides suitably educated and professional trainers who are all experts in the setup, development, supervision and performance of training. In order to enhance the efficacy of in-house courses, PCS may use various training methods; in addition to the transfer of knowledge via (interactive) lectures, intensive use is also made of questionnaires, practical exercises, workshops and photo presentations, if desired.

Advantages

There are a number of advantages to our internal training courses; we follow your schedule, through personal contact the content of the training is highly customizable and you can certify a large number of staff (following relevant training courses regularly is a GMP requirement).

Internal GMP Training Courses PCS

In-House GxP Training Courses

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.

GxP Auditing Training

Auditing (Inspection) of suppliers is a GxP requirement. PCS has a number of auditing courses which can be provided in-house. PCS can focus on your specific GxP Auditing procedures and/or policies.

  • 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
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Engineering

As we are working in a high-risk industry it is essential for engineering activities to be executed according to GxP regulations. PCS can help your Maintenance and Engineering departments develop a better understanding of these regulations and adapt accordingly.

  • 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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Production Process

The production process is the most important element within every pharmaceutical company. To retain control of this process is essential to adhering to GxP regulations. These PCS courses are designed to assist your company in controlling, upgrading and assessing your production processes.

  • Packaging
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  • Aseptic Production
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  • Environmental Monitoring
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  • Disinfectation 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)
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Quality Management Systems

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.

  • 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
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Quality Control (QC)

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 GxP regulations. PCS can help your QC department reduce deviations and apply to regulatory requirements through its courses specifically designed for the Quality Control laboratory.

  • 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
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General GXP Courses

The following courses do not apply to a specific category but are designed to offer participants different levels of GxP 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.

  • 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
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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
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