Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>Events>This Event
  Events - June 2013

GMP Auditor Training for Quality Systems

11 Jun 2013 - 12 Jun 2013 - Amsterdam, Netherlands

Bookmark and Share

This 2 day course is aimed at Quality Assurance auditors and production management for Level 2 internal audits and supplier auditing.

To be a business benefit rather than a drain on resources, your auditing programmes must be integral to continuous improvement. The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channelled to achieve business and compliance improvements.

Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, the audit team, structuring the audit, close out, CAPAs and follow up.

Who Should Attend?

  •   QA auditors and trainees
  •   Production managers who receive internal QA and corporate GMP audits
  •   Engineering managers who receive internal QA and corporate
  •   GMP audits
  •   Production supervisors who lead Self Inspection audits
  •   Auditors of suppliers and contractors

Course Programme

Part 1: Auditing Basics

  •   Purpose of audits and audit models (overview)
  •   Role Characteristics of the Auditor
  •   Audit Types and Classification
  •   Audit Methods
  •   General Themes for All Audits

Part 2: Auditing Tools and Techniques

  •   Basic auditing tools
  •   Audit Techniques
  •   Audit scheduling, planning and management

Part 3: The audit process

  •   Audit scheduling
  •   Conducting the audit
  •   Managing an Audit Team
  •   The Exit Meeting
  •   Audit Reporting and closeout

Part 4: Improving the audit system

  •   Adding Value from the Audit programme
  •   Organisation of the internal audit programme (Self Inspection)

Part 5: How to Audit CAPA, OOS and QRM

  •   The necessity for structured investigation
  •   Corrective and Preventive Action procedures
  •   Out of Specification procedures
  •   Risk Assessment techniques

Part 6: Auditing API Manufacturers

  •   Why Audit API Manufacturers
  •   Control of raw materials and process intermediates
  •   Handling Manufacturing Deviations
  •   QC Laboratories
  •   Distribution
  •   Computer systems
  •   QP Declaration

Part 7: Auditing Products Manufacturers

  •   Oral solid and liquid dosage forms
  •   Packaging and labelling
  •   Distribution
  •   QC Laboratories
  •   Computer systems

Part 8: Auditing for Approval of Contractors / Suppliers

  •   Technical requirements (physical properties, purity, quantity, frequency, etc)
  •   Critical steps and controls
  •   Preferred location (UK, EU, Far East, world-wide)
  •   Key points of contract (Quality Technical Agreement)

The course will include several Workshops on specific aspects of the programme

Further information
Scientific News
New Class of RNA Tumor Suppressors Identified
Two short, “housekeeping” RNA molecules block cancer growth by binding to an important cancer-associated protein called KRAS. More than a quarter of all human cancers are missing these RNAs.
Mathematical Model Forecasts the Path of Breast Cancer
Chances of survival depend on which organs breast cancer tumors colonize first.
Exploring the Causes of Cancer
Queen's research to understand the regulation of a cell surface protein involved in cancer.
Nanocarriers May Carry New Hope for Brain Cancer Therapy
Berkeley lab researchers develop nanoparticles that can carry therapeutics across the brain blood barrier.
RNA-Based Drugs Give More Control Over Gene Editing
CRISPR/Cas9 gene editing technique can be transiently activated and inactivated using RNA-based drugs, giving researchers more precise control in correcting and inactivating genes.
University of Glasgow Researchers Make An Impact in 60 Seconds
Early-career researchers were invited to submit an engaging, dynamic and compelling 60 second video illuminating an aspect of their research.
Metabolic Profiles Distinguish Early Stage Ovarian Cancer with Unprecedented Accuracy
Studying blood serum compounds of different molecular weights has led scientists to a set of biomarkers that may enable development of a highly accurate screening test for early-stage ovarian cancer.
Dead Bacteria to Kill Colorectal Cancer
Scientists from Nanyang Technological University (NTU Singapore) have successfully used dead bacteria to kill colorectal cancer cells.
CRISPR-Cas9 Gene Editing: Check Three Times, Cut Once
Two new studies from UC Berkeley should give scientists who use CRISPR-Cas9 for genome engineering greater confidence that they won’t inadvertently edit the wrong DNA.
Genetically Engineering Algae to Kill Cancer Cells
New interdisciplinary research has revealed the frontline role tiny algae could play in the battle against cancer, through the innovative use of nanotechnology.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos