Corporate Banner
Satellite Banner
RNAi
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
Turning Skin Cells into Heart, Brain Cells
In a major breakthrough, scientists at the Gladstone Institutes transformed skin cells into heart cells and brain cells using a combination of chemicals.
Detection of HPV in First-Void Urine
Similar sensitivity of HPV test on first void urine sample compared to cervical smear.
Potential “Good Fat” Biomarker
New method to measure the activity of energy consuming brown fat cells could ease the testing weight loss drugs.
Shape Of Tumor May Affect Whether Cells Can Metastasize
Illinois researchers found that the shape of a tumor may play a role in how cancer cells become primed to spread.
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Analysis of Dog Genome will Provide Insight into Human Disease
An important model in studying human disease, the non-coding RNA of the canine genome is an essential starting point for evolutionary and biomedical studies – according to a new study led by The Genome Analysis Centre (TGAC).
New Blood Test for The Earlier Diagnosis of Breast Cancer Spread
Researchers at University of Westminster have confirmed that a new blood test can detect if breast cancer has spread to other parts of the body.
First Gene Therapy Successful Against Human Aging
American woman gets biologically younger after gene therapies.
Targeting an ‘Undruggable’ Cancer Gene
RAS genes are mutated in more than 30 percent of human cancers and represent one of the most sought-after cancer targets for drug developers.
Altered Metabolism of Four Compounds Drives Glioblastoma Growth
Findings suggest new ways to treat the malignancy, slow its progression and reveal its extent more precisely.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!