Corporate Banner
Satellite Banner
Pharma Outsourcing
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
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
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