Training

A key requirement to achieve cGMP is ensuring that employees have the necessary training and skills pertaining to their job function and role. PSC Asia has, over the years, gathered a considerable portfolio of training courses and seminars aimed at providing people working within a GxP environment, the necessary background and tools to perform their jobs to the level required.
Training programs can be developed and tailored to meet a customer’s specific needs. The courses are designed at the level of content and length, to fit perfectly to the needs of each trainee organization. The training can be divided into theoretical and practical components, with real life examples taken from your organization.
Training can be conducted at a location to suit your team. We can use your existing facilities or a third party conference centre, or utilise our in-house training facilities. Catering for up to 30 trainees, we can provide a dedicated, offsite location to allow delegates to focus on the training without interruption.

Training topics offered by PSC Asia

Please note; all training courses are individually modified to meet specific client requirements. We can train in our facilities, at your site or at an offsite venue. The majority of courses listed below run from half a day to 3 days depending on the depth of knowledge required. If you do not see a topic listed below that meets your requirements, please contact us. We can often develop a specific course that meets your needs.

Validation

  • Introduction to Validation
  • Cleaning Validation
  • Integrated Commissioning and Qualification
  • Qualifying Laboratory Equipment
  • Analytical Method Validation
  • System Boundary and System Impact Assessment
  • Validation Risk Assessments
  • Process Validation
  • Validation Master Planning, Protocols and Reports
  • Management and Design of Sterile Process Validation
  • Qualifying Facilities, Equipment and Facilities
  • HVAC and Clean Room Validation
  • Computer Systems Validation
  • Validation of Thermal Sterilization

Quality

  • The CAPA Process
  • Managing Change Control
  • Quality Risk Management
  • Tools and Techniques for Risk Assessment
  • Setting up your Quality Management System
  • Meeting ISO 9001:2008
  • Writing your Quality Manual

Pharmaceutical Knowledge

  • Understanding API Manufacture
  • Understanding Oral Solid Dosage Manufacture
  • Understanding manufacture of non sterile liquids, ointments and creams
  • Understanding sterile product manufacturing
  • Understanding manufacture of Biologicals
  • Working in Clean rooms
  • Effective Cleaning and Microbial control
  • Requirements for Containment
  • Containment principles and equipment
  • Materials Transfer Technology
  • Biological containment
  • Process Simulation testing (media fills)
  • Thermal Sterilization Overview

ICH

  • ICH Quality Requirements for Biological Products
  • ICH Requirements for Stability Testing

Medical DevicesMedical Devices

  • Quality System Regulation

Automated Systems

  • Developing Requirements Traceability Matrices
  • Electronic Signatures and Electronic Records
  • Understanding GAMP

GMP

  • GMP –an overview
  • GMP Activities during Design and Construction
  • Premises and Equipment – GMP Requirements
  • Production – GMP Requirements
  • Quality Assurance – GMP Requirements
  • Quality Control – GMP Requirements
  • Personnel – GMP Requirements
  • Sampling – GMP Requirements
  • Contract manufacture – GMP Requirements
  • GMP Compliance of Outsourced Activities
  • Complaints – GMP Requirements
  • Documentation Basics
  • Good Documentation Practices
  • Good Technical Writing and Reviewing
  • EU GMP Sterile Annex 1
  • EU and FDA GMP updates
  • GMP Hot Topics
  • Upgrading to meet International GMP Requirements

GxP

  • Good Engineering Practice
  • GEP Equipment Maintenance Principles
  • GEP Calibration Principles
  • Good Tissue Practice
  • Good Distribution Practice
  • Understanding Your Supply Chain
  • OECD GLP
  • Meeting GLP in your Laboratory
  • Operating in a GLP Environment

Regulatory Requirements

  • WHO requirements for Biological Products
  • EU and FDA Requirements for Biological Products

New Products

  • ANDA Requirements
  • Getting EU Marketing Authorization

Auditing

  • Self Inspection and Internal Audits
  • Auditing Suppliers
  • Preparing for a Regulatory Inspection
  • Managing your Inspector
  • 483s and Warning letters
  • Performing Gap Analysis

Design Principles

  • GMP Facility Design
  • Conceptual Design
  • Designing for Containment

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