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
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Researchers Find Key Player in Diabetic Kidney Disease Through Power of Metabolomics
Discovery could lead to new and better diagnostic marker for chronic kidney disease.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Santhera Announces First Patient Dosing with Omigapil in CMD
Company announces full patient recruitment of CALLISTO study.
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Early Antiretroviral Therapy Prevents Non-AIDS Outcomes in HIV-infected People
NIH-supported findings illustrate manifold benefit of therapy.
Adaptimmune’s NY-ESO-1 TCR-engineered T-Cells Demonstrate Durable Persistence
Study has been published in Nature Medicine.
Scroll Up
Scroll Down
SELECTBIO

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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!